FDA adverse reactions (665)

January 10, 2009

Is there any specific reason you don't want them to be scared of this ?

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:12/01/97ISR Number: 3003007-4Report Type:Expedited (15-DaCompany Report #971121-008013188 Age:82 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Hyperglycaemia Foreign Haldol PS ORAL ORAL

Hypokalaemia Health Risperidone SS ORAL ORAL

Hyponatraemia Professional Cisapride SS ORAL 10 MG, TID,

ORAL

Buflomedil SS ORAL 15O MG, QD,

ORAL

Propafenone SS 300 MG, QD

Zopiclone SS ORAL 7.5 MG,ORAL

Paroxetine SS ORAL 20 MG, ORAL

Macrogol SS ORAL ORAL

Gaviscon SS ORAL ORAL

Efferalgan SS ORAL ORAL

Unknown C

Date:01/28/98ISR Number: 3021591-1Report Type:Direct Company Report # Age:50 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Nausea Colyte PS ORAL 4L PO X 1

Date:01/28/98ISR Number: 3021649-7Report Type:Direct Company Report # Age:68 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Asthenia Colyte PS 4 L PO X1

Vomiting

Date:01/28/98ISR Number: 3087029-3Report Type:Direct Company Report # Age:50 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Nausea Colyte PS ORAL 4 L PO X 1

Date:02/05/98ISR Number: 3024084-0Report Type:Expedited (15-DaCompany Report #971121-008013188 Age:82 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Sudden Death Foreign Haldol PS ORAL UNK, UNK,

Health ORAL

Professional Risperidone SS ORAL UNK, UNK,

ORAL

Cisapride SS ORAL 10 MG, TID,

ORAL

Buflomedil SS ORAL 150 MG, QD,

ORAL

Propafenone SS 300 MG, QD,

UNK

Zopiclone SS ORAL 7.5 MG, UNK,

ORAL

Paroxetine SS ORAL 20 MG, UNK,

ORAL

18-Apr-2007 11:25 AM Page: 1

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Macrogol SS ORAL UNK, UNK,

ORAL

Gaviscon SS ORAL UNK, UNK,

ORAL

Efferalgan SS ORAL UNK, UNK,

ORAL

Date:03/03/98ISR Number: 3040331-3Report Type:Expedited (15-DaCompany Report #94236 Age:37 YR Gender:Male I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Blood Amylase Increased Foreign Bactrim Forte PS ORAL 480 MG 1 X

Hospitalization - Blood Creatinine Other PER DAY ORAL

Initial or Prolonged Increased Zelitrex SS ORAL 500 MG 6 X

Blood Urea Increased PER DAY ORAL

Lipase Increased Forlax SS ORAL 10 GRAM 6 X

Lymphoma PER DAY ORAL

Pancreatitis Mag 2 SS ORAL 2.250 MG 2 X

PER DAY ORAL

Zovirax SS INTRAVENOUS 600 MG 3 X

PER DAY

INTRAVENOUS

Skenan Lp SS ORAL 20 MG 2 X PER

DAY ORAL

Date:03/13/98ISR Number: 3054911-2Report Type:Expedited (15-DaCompany Report #B0053861 Age:37 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Blood Creatinine Foreign Valacyclovir PS ORAL (TABLET)

Initial or Prolonged Increased Magnesium Pidolate SS ORAL

Other Blood Urea Increased Zovirax SS INTRAVENOUS 600 MG

Lymphoma (STERILE

Pancreatitis POWDER)THREE

TIMES PER DAY

Macrogol SS ORAL SIX TIMES PER

DAY

Morphine Sulphate SS ORAL 20 MG /TWICE

PER DAY

Septra SS ORAL 480 MG

(TABLET)/PER

DAY

Date:03/16/98ISR Number: 3056047-3Report Type:Expedited (15-DaCompany Report #94236 Age:37 YR Gender:Male I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Abdominal Pain Foreign Bactrim Forte PS ORAL 480.0000 MG

Hospitalization - Blood Amylase Increased Other 1.0 X PER DAY

Initial or Prolonged Blood Creatinine ORAL

Increased Zelitrex SS ORAL 500.0000 MG

Blood Urea Increased 6.0 X PER DAY

Herpes Zoster Mag 2 SS ORAL 2.500 MG 2.0

Ileus Paralytic X PER DAY

Lipase Increased ORAL

Lymphoma Aids Related Forlax SS ORAL 10.0000 GRAM

Pancreatitis 6.0 X PER DAY

ORAL

18-Apr-2007 11:25 AM Page: 2

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Zovirax SS INTRAVENOUS 600.0000 MG

3.0 X PER DAY

INTRAVENOUS

Invirase SS

Skenan Lp SS ORAL 20.0000 MG

2.0 X PER DAY

ORAL

Norvir C

Zerit C

Epivir C

Date:03/20/98ISR Number: 3057049-3Report Type:Expedited (15-DaCompany Report #199810592RHF Age:51 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Anaphylactic Shock Foreign Sucralfate PS ORAL 1 G/DAY PO 2 DAY

Initial or Prolonged Rash Generalised Paracetamol,

Rash Maculo-Papular Dextropropoxyphene

Rash Pruritic Hydrochloride SS ORAL ORAL 9 WK

Vitamins Nos SS ORAL ORAL 2 DAY

Troxerutin, Ginkgo

Leaves Extract SS ORAL ORAL 9 WK

Metopimazine SS ORAL ORAL 5 DAY

Ciprofloxacin SS INTRAVENOUS QD IV 2 DAY

Methylprednisolone SS 5 DAY

Macrogol SS 5 WK

Date:04/03/98ISR Number: 3061359-3Report Type:Expedited (15-DaCompany Report #B0053861 Age:37 YR Gender:Male I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Abdominal Pain Foreign Valaciclovir PS ORAL ORAL

Hospitalization - Blood Amylase Increased Magnesium Pidolate SS ORAL ORAL

Initial or Prolonged Blood Creatinine Zovirax SS INTRAVENOUS 600 MG/THREE

Increased TIMES PER DAY

Blood Urea Increased INTRAVENOUS

Intestinal Obstruction Macrogol 4000 SS ORAL SIX TIMES PER

Lipase Increased DAY ORAL

Lymphoma Morphine SS ORAL 20 MG/TWICE

Necrosis PER DAY/ORAL

Pancreatitis Acute Septra SS ORAL 480 MG/PER

DAY/ORAL

Date:05/07/98ISR Number: 3074639-2Report Type:Expedited (15-DaCompany Report #B0053861 Age:37 YR Gender:Male I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Abdominal Pain Foreign Valaciclovir PS ORAL ORAL

Hospitalization - Arterial Occlusive Magnesium Pidolate SS ORAL ORAL

Initial or Prolonged Disease Zovirax Sterile

Other Blood Amylase Increased Powder SS INTRAVENOUS 600 MG/THREE

Blood Creatinine TIMES PER DAY

Increased INTRAVENOUS

Blood Urea Increased Macrogol 4000 SS ORAL SIX TIMES PER

Lipase Increased DAY/ORAL

Necrosis Morphine Sulphate SS ORAL 20 MG/TWICE

Pancreatitis Acute PER DAY/ORAL

Septra SS ORAL 480 MG /PER

18-Apr-2007 11:25 AM Page: 3

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

DAY/ORAL

Date:07/01/98ISR Number: 3100677-7Report Type:Expedited (15-DaCompany Report #1998AP46578 Age:53 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Life-Threatening Anaphylactic Shock Foreign Atenolol PS

Literature Macrogol SS

Health

Professional

Other

Date:07/02/98ISR Number: 3108606-7Report Type:Direct Company Report # Age:49 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Life-Threatening Abdominal Pain Upper Golytely PS

Anaphylactoid Reaction

Cardiac Failure

Congestive

Coronary Artery Disease

Diarrhoea

Diverticulum

Dysphonia

Dyspnoea

Nausea

Pharyngolaryngeal Pain

Tongue Oedema

Vomiting

Date:08/03/98ISR Number: 3111591-5Report Type:Direct Company Report # Age:4.5 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Anion Gap Increased Golytely PS Braintree

Life-Threatening Brain Oedema Laboratories Inc 2400CC PER NG

Other Gastrointestinal Disorder TUBE OVER 12

Hyponatraemia HOURS

Metabolic Acidosis Fentanyl C

Neuropathy Peripheral Ondansetron C

Date:08/11/98ISR Number: 3115488-6Report Type:Expedited (15-DaCompany Report #002#4#1998-00152000 Age: Gender: I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Life-Threatening Medication Error Health Colyte PS NASAL NASAL

Hospitalization - Pulmonary Function Test Professional

Initial or Prolonged Decreased

Date:11/11/98ISR Number: 3155050-2Report Type:Direct Company Report # Age:71 YR Gender:Male I/FU:I

Outcome PT

Hospitalization - Chest Pain

Initial or Prolonged Chills

Pyrexia

Retching

18-Apr-2007 11:25 AM Page: 4

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Tremor

Vomiting

Report Source Product Role Manufacturer Route Dose Duration

Golytely PS ONCE

Colace C

Asa C

Dorzolamide

Ophthalmic C

Date:12/31/98ISR Number: 3177008-XReport Type:Expedited (15-DaCompany Report #111159 Age:88 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Abdominal Pain Foreign Rocephine PS INTRAVENOUS 1 GRAM 1 X

Hospitalization - Hallucination Other PER DAY

Initial or Prolonged Intestinal Obstruction INTRAVENOUS

Miosis Loxen SS ORAL ORAL

Urinary Retention Maalox SS ORAL 3 DOSE FORM 3

Vomiting X PER DAY

ORAL

Forlax SS ORAL 2 DOSE FORM 1

X PER DAY

ORAL

Clivarine SS SUBCUTANEOUS SUBCUTANEOUS

Skenan SS ORAL 60 MG 2 X PER

DAY ORAL

Date:01/22/99ISR Number: 3184608-XReport Type:Expedited (15-DaCompany Report #990001 Age:60 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Required Intestinal Perforation Health Golytely PS ORAL 500 CC PO

Intervention to Professional

Prevent Permanent

Impairment/Damage

Date:03/12/99ISR Number: 3218990-1Report Type:Expedited (15-DaCompany Report #201719 Age:88 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Abdominal Pain Foreign Loxen (Nicardipine

Hospitalization - Hallucination Other Hydrochloride) PS ORAL ORAL 9 DAY

Initial or Prolonged Ileus Paralytic Rocephine

Miosis (Ceftriaxone Sodium) SS INTRAMUSCULAR INTRAMUSCULAR

Urinary Retention Maalox (Aluminum

Vomiting Hydroxide/Magnesium

Hydroxide) SS

Forlax (Polyethylene

Glycol) SS

Clivarine (Reviparin

Sodium) SS

Morphine Sulfate C

18-Apr-2007 11:25 AM Page: 5

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:03/16/99ISR Number: 3220543-6Report Type:Direct Company Report # Age: Gender: I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Medication Error Colyte PS ORAL

Date:04/30/99ISR Number: 3251233-1Report Type:Expedited (15-DaCompany Report #201719 Age:88 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Abdominal Pain Foreign Loxen (Nicardipine

Hospitalization - Hallucination Other Hydrochloride) PS ORAL 9 DAY

Initial or Prolonged Ileus Paralytic Rocephine

Miosis (Ceftriaxone Sodium) SS INTRAMUSCULAR

Urinary Retention Maalox (Aluminum

Vomiting Hydroxide/Magnesium

Hydroxide) SS

Forlax (Polyethylene

Glycol) SS

Clivarine (Reviparin

Sodium) SS

Morphine Sulfate

(Morphine Sulfate) C

Date:08/23/99ISR Number: 3332612-0Report Type:Expedited (15-DaCompany Report #002#1#1999-00294 Age:16 MON Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Aspiration Health Colyte-For-Oral-Solu

Initial or Prolonged Medication Error Professional tion (Sodium

Respiratory Disorder Bicarbonate,

Potassium Chloride,

Sodium Chloride, PS ORAL 4 LIT, 1 IN 1

D, ORAL

Sulfamethoxazole/Tri

methoprim C

Date:08/31/99ISR Number: 3338228-4Report Type:Expedited (15-DaCompany Report #201719 Age:88 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Abdominal Pain Foreign Loxen (Nicardipine

Hospitalization - Hallucination, Visual Other Hydrochloride) PS ORAL ORAL 9 DAY

Initial or Prolonged Ileus Paralytic Rocephine

Miosis (Ceftriaxone Sodium) SS INTRAMUSCULAR INTRAMUSCULAR

Urinary Retention Maalox (Aluminum

Vomiting Hydroxide/Magnesium

Hydroxide) SS

Forlax (Polyethylene

Glycol) SS

Clivarine (Reviparin

Sodium) SS

Morphine Sulfate C

18-Apr-2007 11:25 AM Page: 6

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:09/01/99ISR Number: 3339417-5Report Type:Expedited (15-DaCompany Report #201719 Age:88 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Abdominal Pain Foreign Loxen (Nicardipine

Hospitalization - Hallucination Other Hydrochloride) PS ORAL ORAL 9 DAY

Initial or Prolonged Ileus Paralytic Rocephine

Miosis (Ceftriaxone Sodium) SS INTRAMUSCULAR INTRAMUSCULAR

Urinary Retention Maalox (Aluminum

Vomiting Hydroxide/ Magnesium

Hydroxide) SS

Forlax (Polyethylene

Glycol) SS

Clivarine (Reviparin

Sodium) SS

Morphine Sulfate C

Date:09/02/99ISR Number: 3339800-8Report Type:Expedited (15-DaCompany Report #B0069440A Age:95 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Cholangitis Foreign Macrogol

Initial or Prolonged Coombs Direct Test (Formulation

Positive Unknown) PS

Haemolytic Anaemia Potassium Chloride

(Formulation

Unknown) SS

Gelopectose

(Formulation

Unknown) SS

Zyloprim Tablet SS

Omeprazole

(Formulation

Unknown) SS ORAL 20 MG DAILY

ORAL

Isosorbide Dinitrate

(Formulation

Unknown) SS ORAL ORAL

Colchimax

(Formulation

Unknown) SS ORAL ORAL

Quinapril

(Formulation

Unknown) SS ORAL ORAL

Frusemide

(Formulation

Unknown) SS ORAL ORAL

Nitroglycerin

(Formulation

Unknown) SS PATH

Alfuzosin Tablet SS ORAL 1TABLET PER

DAY ORAL

Nicoumalone Tablet SS ORAL 1 TABLET PER

DAY ORAL

18-Apr-2007 11:25 AM Page: 7

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:09/08/99ISR Number: 3343153-9Report Type:Expedited (15-DaCompany Report #214164 Age:48 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Petechiae Foreign Valium (epam) 1% PS ORAL 4 DROP DAILY

Initial or Prolonged Vascular Purpura Other ORAL

Lutheran

(Chlormadinone

Acetate) 5 Mg SS ORAL 5 MG DAILY

ORAL

Depakine (Valproate

Sodium) SS ORAL ORAL

Lioresal (Baclofen)

10 Mg SS ORAL 30 MG 3 PER

DAY ORAL

Forlax (

Polyethylene Glycol)

10gram SS ORAL 30 GRAM DAILY

ORAL

Date:09/09/99ISR Number: 3347059-0Report Type:Periodic Company Report #990007 Age:89 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Diarrhoea Consumer Miralax PS ORAL 17 GRAM DAILY

Nausea PO

Date:09/27/99ISR Number: 3358169-6Report Type:Direct Company Report # Age:81 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Cardiac Failure Health Golytely PS ONCE

Initial or Prolonged Congestive Professional

Condition Aggravated

Date:11/15/99ISR Number: 3399336-5Report Type:Expedited (15-DaCompany Report #10167070 Age:74 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Tongue Oedema Foreign Vasten Tabs 20mg

Initial or Prolonged Health (Pravastatin Sodium) PS ORAL 10 MILLIGRAM,

Professional 1 DAY ORAL

Other Diamicron(Gliclazide

) SS

Zestril(Lisinopril) SS 4000

Lasilix(Furosemide) SS

Diffu-K(Potassium

Supplements) SS

Macrogol SS

Tanakan(Ginkgo

Biloba) C

Jonctum(Oxaceprol) C

Ginkor(Ginkgo

Biloba+Heptaminol+) C

18-Apr-2007 11:25 AM Page: 8

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:11/16/99ISR Number: 3397967-XReport Type:Direct Company Report # Age:81 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Rhinorrhoea Health Golightly PS 4 LITERS1CUP

Professional Q15 MIN PER

NGT

Date:12/01/99ISR Number: 3411732-6Report Type:Direct Company Report #USP 52654 Age: Gender: I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Medication Error Health Miralax PS Braintree Labs

Professional Mirapex (Pramipexole

Dihydrochloride) SS Pharmacia & Unjohn

Date:01/18/00ISR Number: 3446137-5Report Type:Expedited (15-DaCompany Report #HQ0042430DEC1999 Age:58 YR Gender:Male I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Burns Second Degree Health Temesta Tablet

Initial or Prolonged Erythema Multiforme Professional (Lorazepam) PS

Other Pain Deroxat (Paroxetine

Skin Exfoliation Hydrochloride) SS

Klean-Prep

(Macrogol, Potassium

Chloride, Sodium

Bicarbonate, Sodium

Chloride, Sodium SS

Lioresal (Baclofen) SS

Normacol (Frangula

Extract, Sterulia) SS SEE IMAGE

Date:02/22/00ISR Number: 3462012-4Report Type:Expedited (15-DaCompany Report #2000CG00101 Age:64 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Leukocytoclastic Foreign Diprivan PS

Initial or Prolonged Vasculitis Health Rapifen SS

Nodular Vasculitis Professional Hypnovel SS

Purpura Other Ephedrine SS

Visceralgine SS

Ulcar SS

Klean-Prep SS

Atorvastatin C

Fonzylane C

Kardegic C

Date:02/28/00ISR Number: 3464392-2Report Type:Expedited (15-DaCompany Report #B0076632A Age:92 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Hyponatraemia Foreign Zantac Tablet

Initial or Prolonged Inappropriate -Effervescent

Antidiuretic Hormone (Ranitidine

Secretion Hydrochloride) PS ORAL 150 MG ORAL

Oedema Peripheral Domperidone

(Domperidone) SS ORAL THREE TIMES

18-Apr-2007 11:25 AM Page: 9

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

PER DAY ORAL

Citalopram

(Citalopram) SS ORAL PER DAY ORAL

Macrogol 3350

(Macrogol 3350) SS ORAL FOUR TIMES

PER DAY ORAL

Trimebutine C

Di-Antalvic C

Carbomere C

Potassium Chloride C

Date:03/07/00ISR Number: 3470394-2Report Type:Direct Company Report # Age: Gender: I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Life-Threatening Peritonitis Golyte PS PO

Date:03/14/00ISR Number: 3474503-0Report Type:Direct Company Report #USP 52905 Age: Gender: I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Medication Error Miralax PS Braintree Labs

Mirapex

(Promipexole) SS Pharmacia & Upjohn

Date:04/14/00ISR Number: 3487816-3Report Type:Direct Company Report #USP 52991 Age:79 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Medication Error Mirapex PS Pharmacia & Upjohn

Miralax

(Polyethylene Glyol) SS Braintree Labs

Date:04/21/00ISR Number: 3490965-7Report Type:Expedited (15-DaCompany Report #1346832A Age:39 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Dysphagia Consumer Tylenol Sore Throat

Required Laryngospasm Product PS ORAL 2

Intervention to Odynophagia TABLESPOONS,

Prevent Permanent Pharyngitis PRN, PO

Impairment/Damage Sensation Of Foreign Body

Speech Disorder

Throat Tightness

Vomiting

Date:05/25/00ISR Number: 3566076-9Report Type:Periodic Company Report #000008 Age:76 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Nausea Other Miralax PS Braintree

Laboratories Inc ORAL 17 GRAMS

ONE/DAY, ORAL 6 MON

18-Apr-2007 11:25 AM Page: 10

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:08/03/00ISR Number: 3540387-5Report Type:Expedited (15-DaCompany Report #200429 Age:42 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Abdominal Pain Foreign X-Prep Liquid PS ORAL 2 DF QD PO

Initial or Prolonged Appendicitis Health Colopeg

Condition Aggravated Professional (Macrogol/Kcl/Naco3/

Peritonitis Company Nacl/Naso4) SS ORAL 2 DF QD PO

Vomiting Representative

Other

Date:08/23/00ISR Number: 3556117-7Report Type:Direct Company Report # Age:16 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Required Abdominal Distension Golytely PS 150 CC/HR PER

Intervention to Blood Creatinine G-TUBE

Prevent Permanent Increased

Impairment/Damage Blood Urea Increased

Hypotension

Sluggishness

Tachycardia

Wound Secretion

Date:09/08/00ISR Number: 3568189-4Report Type:Direct Company Report #USP 53263 Age:42 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Medication Error Mirapex PS Pharmacia/Upjohn

Miralax SS Braintree Lab

Date:10/19/00ISR Number: 3598396-6Report Type:Direct Company Report # Age:3 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Abdominal Pain Miralax Mfd By

Initial or Prolonged Abnormal Behaviour Braintree Labs PS Braintree Labs SEE ITEM B5 11 DAY

Antisocial Behaviour

Bipolar I Disorder

Convulsion

Decreased Appetite

Depressed Mood

Disturbance In Attention

Fear

Feeling Cold

Frequent Bowel Movements

Insomnia

Movement Disorder

Neurological Symptom

Night Sweats

Obsessive-Compulsive

Disorder

Paranoia

Speech Disorder

Staring

Throat Tightness

Tremor

18-Apr-2007 11:25 AM Page: 11

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:10/20/00ISR Number: 3598900-8Report Type:Direct Company Report # Age:71 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Haemoglobin Decreased Golytely PS AS DIRECTED

Life-Threatening Haemorrhage

Intestinal Perforation

Sepsis

Date:10/23/00ISR Number: 3599878-3Report Type:Expedited (15-DaCompany Report #002#1#2000-00228 Age:71 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Abdominal Pain Health Colyte PS Schwarz Pharma Inc ORAL 41, ONCE,

Flatulence Professional ORAL

Shock Digoxin C

Levothyroxine-Sodium C

Isosorbide-Dinitrate C

Atenolol C

Date:11/06/00ISR Number: 3607898-5Report Type:Expedited (15-DaCompany Report #002#1#2000-00228(1) Age:71 YR Gender:Male I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Abdominal Pain Health Colyte PS Schwarz Pharma Inc ORAL 41, ONCE,

Shock Professional ORAL

X-Ray Gastrointestinal Digoxin C

Tract Abnormal Levothytroxine-Sodiu

m C

Isosorbide-Dinitrate C

Atenolol C

Date:11/14/00ISR Number: 3610886-6Report Type:Direct Company Report # Age:3 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Abnormal Behaviour Miralax PS Braintree Labs SEE ITEM B5 11 DAY

Initial or Prolonged Adjustment Disorder

Bipolar I Disorder

Convulsion

Decreased Appetite

Depressed Mood

Enuresis

Fear

Feeling Abnormal

Frequent Bowel Movements

Muscle Spasms

Nervous System Disorder

Nervousness

Night Sweats

Obsessive-Compulsive

Disorder

Paranoia

Sleep Disorder

Throat Tightness

Tremor

18-Apr-2007 11:25 AM Page: 12

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:11/28/00ISR Number: 3622979-8Report Type:Periodic Company Report #000019 Age:3 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Convulsion Other Miralax PS Braintree

Initial or Prolonged Delusion Laboratories Inc ORAL 17 G QD PO

Paranoia

Social Avoidant Behaviour

Tremor

Date:11/28/00ISR Number: 3622981-6Report Type:Periodic Company Report #000022 Age:41 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Hypersensitivity Consumer Miralax PS Braintree

Laboratories Inc ORAL 17 GRAMS PO

Date:11/28/00ISR Number: 3622985-3Report Type:Periodic Company Report #000017 Age:26 MON Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Convulsion Consumer Miralax PS Braintree

Laboratories Inc ORAL 8.5 GRAMS QD

PO 1 WK

Date:11/28/00ISR Number: 3622987-7Report Type:Periodic Company Report #000015 Age:63 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Chest Pain Other Miralax PS Braintree

Initial or Prolonged Laboratories Inc ORAL 17 GRAMS QD

PO

Mavik SS ORAL 2 MCG QD PO

Atenolol SS ORAL 50 MG QD PO

Ms Contin/Morphine

Sulfate SS ORAL 30 MG BID PO

Dilaudid/Hydromorpho

ne Hydrochloride SS ORAL 2 MG PRN PO

Pericolace SS ORAL 1 TAB BID PO

Flomax SS ORAL 0.4 MG QD PO

Amaryl/Glimepiride SS ORAL 2 MG QD PO

Asa/Acetylsalicylic

Acid C

Lopid/Gemfibrozil C

Tagamet/Cimetidine C

Date:11/28/00ISR Number: 3631935-5Report Type:Periodic Company Report #000016 Age:3 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hypersensitivity Health Miralax PS Braintree

Professional Laboratories Inc ORAL 17 GRAMS QD

PO

18-Apr-2007 11:25 AM Page: 13

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:11/28/00ISR Number: 3631937-9Report Type:Periodic Company Report #000018 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Vomiting Consumer Miralax PS Braintree

Laboratories Inc ORAL 17 GRAMS QD

PO

Date:12/01/00ISR Number: 3620980-1Report Type:Expedited (15-DaCompany Report #0011034 Age: Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Corneal Disorder Foreign Hypotears PS OPHTHALMIC 1 DAY

Initial or Prolonged Health Effexor Xr 150mg C

Professional

Other

Date:12/01/00ISR Number: 3628282-4Report Type:Periodic Company Report #002#1#2000-00101(0) Age:40 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Life-Threatening Anaphylactoid Reaction Health Colyte PS Schwarz Pharma Inc ORAL ORAL

Professional

Date:12/07/00ISR Number: 3625146-7Report Type:Expedited (15-DaCompany Report #2000CG00794 Age:62 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Required Angioneurotic Oedema Foreign Zestoretic PS Astrazeneca

Intervention to Drug Interaction Health Pharmaceuticals Lp ORAL 20 MG DAILY

Prevent Permanent Professional PO ; 12.5 MG

Impairment/Damage Other DAILY PO;

Polyethylene Glycol SS

Atenolol C

Ibuprophene C

Lipur C

Date:12/20/00ISR Number: 3635048-8Report Type:Expedited (15-DaCompany Report #200021279FR Age:89 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Anaemia Foreign Lasix PS Aventis

Hospitalization - Antibody Test Abnormal Health Pharmaceuticals Inc ORAL 40 MG DAY PO 2 WK

Initial or Prolonged Condition Aggravated Professional Zopiclone SS ORAL 7.5 MG DAY

Fall Other PO 2 WK

Haematuria Ferrous Sulfate

Haemoptysis (Tardyferon) SS ORAL QD PO

Rectal Haemorrhage Amlodipine Besilate

Thrombocytopenia (Amlor) SS ORAL SEE IMAGE 18 DAY

Macrogol (Forlax)

Powder For Oral

Solution SS ORAL 20 G DAY PO

18-Apr-2007 11:25 AM Page: 14

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:01/25/01ISR Number: 3654125-9Report Type:Direct Company Report #USP 53641 Age: Gender: I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Medication Error Golytely PS Braintree POWDER FOR

RECONSTITUTIO

N

Miralax

(Polyethylene

Glycol) SS Braintree POWDER FOR

RECONSTITUTIO

N

Date:01/25/01ISR Number: 3654131-4Report Type:Direct Company Report # Age:10 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Mouth Ulceration Miralax PS ORAL 17 GRAMS ORAL

Bactrim C

Date:02/23/01ISR Number: 3669899-0Report Type:Expedited (15-DaCompany Report #010007 Age:77 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Medication Error Health Golytely PS Braintree

Professional Laboratories Inc 2 LITRES OG

Date:03/06/01ISR Number: 3675237-XReport Type:Direct Company Report # Age: Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Abdominal Tenderness Miralax 17 G/Capful

Constipation Braintree Labs PS Braintree Labs ORAL 1 CAPFUL BID

ORAL

Vincristine 2mg/2ml

Faulding SS Faulding INTRAVENOUS

BOLUS 1.4 Q7D TID

INTRAVENOUS

BOLUS

Prednisone 20mg SS Udl 20 MG

Fluconazole C

Bactrim Ss C

Filgrastim C

Prednisone C

Peri-Colace C

Bisacodyl C

Peridex Oral Rinse C

Ranitidine C

Date:03/06/01ISR Number: 3675615-9Report Type:Expedited (15-DaCompany Report #A103970 Age:87 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Hepatitis C Foreign Feldene PS Pfizer Laboratories

Initial or Prolonged Jaundice Health Div Pfizer Inc ORAL ORAL

Professional Macrogol SS ORAL ORAL

Other Ginkgo Biloba SS OPHTHALMIC ORAL

Captea C

18-Apr-2007 11:25 AM Page: 15

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Aspegic C

Date:04/20/01ISR Number: 3708716-7Report Type:Expedited (15-DaCompany Report #WAES 01037335 Age:79 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Acidosis Foreign Vioxx PS Merck Research

Hospitalization - Condition Aggravated Other Laboratories Div

Initial or Prolonged Hyperkalaemia Merck Co Inc ORAL 12.5 MG/DAILY

Renal Failure PO 2 DAY

Sepsis Tab Spironolactone SS ORAL 50 MG/DAILY

Sudden Death PO

Tab Calcium

Carbonate (+)

Cholecalciferol SS ORAL PO

Powd Polyethylene

Glycol

3350/Kcl/Nahco3/Nacl SS ORAL PO

Zocor C

Aspirin C

Dltiazem

Hydrochloride C

Etidronate Disodium C

Flunitrazepam C

Isosorbide C

Nitroglycerin C

Simethicone C

Sotalol

Hydrochloride C

Date:05/10/01ISR Number: 3720755-9Report Type:Expedited (15-DaCompany Report #002#1#2001-00051 (1) Age:69 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Life-Threatening Candidiasis Health Colyte-Flavored PS Schwarz Pharma Inc ORAL 41, ONCE,

Hospitalization - Coma Professional ORAL

Initial or Prolonged Mental Impairment Lisinopril C

Disability Platelet Count Decreased

Staphylococcal Infection

Throat Irritation

Tongue Oedema

Date:05/18/01ISR Number: 3726246-3Report Type:Expedited (15-DaCompany Report #200113417FR Age:85 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Pneumonitis Foreign Lovenox PS Aventis

Initial or Prolonged Other Pharmaceutical

Products Inc ORAL 300 MG/DAY PO 1 WK

Heparin-Fraction,

Sodium Salt

(Lovenox) SS SUBCUTANEOUS SC

Amiodarone

Hydrochloride

(Cordarone) SS ORAL 200 MG QD PO 5 YR

Enalapril Maleate

(Renitec) SS ORAL 5 MG QD PO 4 YR

Paracetamol

18-Apr-2007 11:25 AM Page: 16

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

(Dafalgan) SS ORAL 3 G/DAY PO 8 DAY

Acetylsalicylate

Lysine (Kardegic) SS ORAL 75 MG QD PO 4 YR

Digoxin (Hemigoxine

Nativelle) SS ORAL 0.125 MG QD

PO 4 YR

Movicol Powder

(Lyophilisate) SS ORAL PO

Domperidone SS ORAL ORAL

Cacit SS ORAL PO

Ondansetron

Hydrochloride

(Zophren) SS ORAL PO

Date:05/22/01ISR Number: 3727239-2Report Type:Expedited (15-DaCompany Report #2001UW05309 Age:85 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Blood Disorder Health Seroquel PS Astrazeneca Lp

Initial or Prolonged Faecaloma Professional Seroquel SS Zeneca ORAL 25 MG BID PO

Renal Failure Acute Fleet Enema SS

Renal Tubular Necrosis Dulcolax SS

Milk Of Magnesia SS

Fleet Mineral Oil

Enema SS

Golytely SS

Magnesium Citrate SS

Zoloft C

Nifedipine Xl C

Metamucil C

Clonidine C

Prilosec C

Lorazepam C

Percocet C

Eulexin C

Date:05/22/01ISR Number: 3727241-0Report Type:Expedited (15-DaCompany Report #002#1#2001-00051 (3) Age:69 YR Gender:Male I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Life-Threatening Angioneurotic Oedema Health Colyte PS Schwarz Pharma Inc ORAL 41, ONCE,

Hospitalization - Coma Professional ORAL

Initial or Prolonged Gram Stain Positive Lisinopril C

Disability Infection

Mental Impairment

Nervous System Disorder

Oral Candidiasis

Platelet Count Decreased

Productive Cough

Pyrexia

Staphylococcal Infection

Throat Irritation

Tongue Oedema

18-Apr-2007 11:25 AM Page: 17

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:05/25/01ISR Number: 3730590-3Report Type:Expedited (15-DaCompany Report #PHRM2001FR01274 Age:78 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Abnormal Behaviour Foreign Transderm-Nitro PS Novartis

Initial or Prolonged Anorexia Health Pharmaceuticals Corp TRANSDERMAL 5 MG, QD,

Weight Decreased Professional TRANSDERMAL

Other Kardegic(Acetylsalic

ylate Lysine) SS 1 DF, QD, UNK

Aricept (Donepezil

Hydrochloride) SS ORAL 1 DF, QD,

ORAL

Transipeg (Macrogol) SS ORAL 1 DF, QD,

ORAL

Date:06/06/01ISR Number: 3735787-4Report Type:Expedited (15-DaCompany Report #002#1#2001-00051(4) Age:69 YR Gender:Male I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Life-Threatening Angioneurotic Oedema Health Colyte-Flavored PS Schwarz Pharma Inc ORAL 41, ONCE,

Hospitalization - Coma Professional ORAL

Initial or Prolonged Depressed Level Of Lisinopril C

Disability Consciousness

Disorientation

Hypertension

Mental Disorder

Nervous System Disorder

Oral Candidiasis

Platelet Count Decreased

Productive Cough

Staphylococcal Infection

Throat Irritation

Thrombocytopenia

Tongue Disorder

Tongue Oedema

Date:06/11/01ISR Number: 3737225-4Report Type:Periodic Company Report #2000090617 Age: Gender:Not SpecifiI/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Drug Interaction Health Claritin PS Schering Corp Sub

Syncope Vasovagal Professional Schering Plough Corp ORAL ORAL

Company Miralax (Macrogol) SS

Representative

Date:07/11/01ISR Number: 3757166-6Report Type:Expedited (15-DaCompany Report #001#1#2001-00106 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Cardiovascular Disorder Health Isomol (Macrogol) PS ORAL 2-3 CACHETS

Dizziness Professional

Syncope

18-Apr-2007 11:25 AM Page: 18

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:08/24/01ISR Number: 3783103-4Report Type:Expedited (15-DaCompany Report #001#1#2001-00132(1) Age:72 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Asthenia Health Isomol (Macrogol) PS ORAL ONCE ORAL

Dizziness Professional Atenolol (Atenolol) C

Tachycardia A-Tocopherolacetat

(Tocopherol) C

Denosentan C

Thiamazole

(Thiamazole) C

Date:09/21/01ISR Number: 3797585-5Report Type:Expedited (15-DaCompany Report #HQ5902512SEP2001 Age:94 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Life-Threatening Agranulocytosis Health Seresta (Oxazepam,

Asthenia Professional Unspec) PS ORAL 10 MG 1X PER

Delirium Other 1 DAY ORAL

Depression Athymil (Mianserin

Hallucination Hydrochloride) SS 30 MG 1X PER

Leukopenia 1 DAY 294 DAY

Lung Disorder Forlax (Macrogol, ) SS

Lymphopenia Haldol (Haloperidol,

Malaise ) SS 292 DAY

Neutrophil Count

Decreased

Viral Infection

Date:09/28/01ISR Number: 3802017-4Report Type:Direct Company Report # Age: Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Life-Threatening Medication Error Colyte (4l) PS Schwarz Pharma NASAL 400 CC/HR NGT

Respiratory Failure X 3 HRS

Date:10/04/01ISR Number: 3805237-8Report Type:Expedited (15-DaCompany Report #002#4#1998-00152(1) Age:9 YR Gender: I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Life-Threatening Iatrogenic Injury Health Colyte-For-Oral-Solu

Hospitalization - Lung Disorder Professional tion (Polyethylene

Initial or Prolonged Medication Error Other Glycol 3350) PS NASAL ONE TIME

Disability Pulmonary Fibrosis DOSE, NASAL 16 HR

Pulmonary Function Test

Decreased

Date:10/11/01ISR Number: 3808143-8Report Type:Expedited (15-DaCompany Report #002#1#2001-00114(1) Age:6 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Life-Threatening Aspiration Health Colyte-For-Oral-Solu

Hospitalization - Atelectasis Professional tion (Polyethylene

Initial or Prolonged Implant Site Reaction Glycol 3350) PS 600ML, ONCE,

Lung Infiltration OTHER

18-Apr-2007 11:25 AM Page: 19

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:10/22/01ISR Number: 3811719-5Report Type:Direct Company Report # Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Drug Ineffective P.E.G. Colyte

Flavored PS ORAL ORAL

Date:10/30/01ISR Number: 3817675-8Report Type:Expedited (15-DaCompany Report #002#1#2001-00114 (2) Age:6 YR Gender:Male I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Life-Threatening Aspiration Health Colyte-For-Oral-Solu

Hospitalization - Atelectasis Professional tion (Polyethylene

Initial or Prolonged Lung Infiltration Glycol 3350) PS 600 ML, ONCE,

Pco2 Increased OTHER

Date:11/14/01ISR Number: 3825559-4Report Type:Expedited (15-DaCompany Report #002#2#2000-00281 Age:61 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Electrolyte Imbalance Consumer Peg-3350- & -Electroly

Hyperhidrosis tes-For-Oral-Solutio

Palpitations n PS ORAL 31,ONCE,ORAL

Aspirin C

Atorvastatin C

Date:11/14/01ISR Number: 3825561-2Report Type:Expedited (15-DaCompany Report #002#2#2000-00309 Age:71 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Feeling Cold Consumer Colyte-For-Oral-Solu

Tremor tion (Polyethylene

Glycol 3350) PS ORAL 41,ONCE, ORAL

Insulin C

Conjugated-Estrogens C

Date:11/14/01ISR Number: 3825563-6Report Type:Expedited (15-DaCompany Report #002#2#2000-00310 Age:55 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Life-Threatening Anaphylactic Reaction Consumer Colyte-With-Flavor-P

Health acks(Citrus-Berry)

Professional (Polyethylene Glycol

3350) PS ORAL 480M.,ONCE,OR

AL

Date:11/14/01ISR Number: 3825565-XReport Type:Expedited (15-DaCompany Report #002#2#2000-00312 Age: Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Chills Consumer Peg-3350- & -Electroly

Drug Effect Decreased tes-For-Oral-Solutio

Faeces Discoloured n(Polyethylene

Muscle Spasms Glycol 3350) PS ORAL 31,ONCE,ORAL

18-Apr-2007 11:25 AM Page: 20

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:11/14/01ISR Number: 3825567-3Report Type:Expedited (15-DaCompany Report #002#1#2001-00003 (1) Age:52 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Fluid Retention Health Coyte-For-Oral-Solut

Hyponatraemia Professional ion (Polyethylene

Urine Osmolarity Glycol 3350) PS OTHER 2.51, ONCE,

Decreased OTHER

Hyperalimentation C

Sodium Chloride 0.9% C

Date:11/14/01ISR Number: 3825578-8Report Type:Periodic Company Report #002#1#2001-00012 (0) Age:63 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Nausea Consumer Colyte-With-Flavor-P

Vomiting Health acks(Lemon-Lime)

Professional (Polyethylene Glycol

3350) PS Schwarz Pharma Inc ORAL 240ML, ONCE,

ORAL

Alendronate C

Conjugated-Estrogens C

Hydroxychloroquine C

Date:11/14/01ISR Number: 3825582-XReport Type:Periodic Company Report #002#2#2001-00014 (0) Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Therapeutic Response Consumer Colyte With Flavor

Decreased Packs PS Schwarz Pharma Inc ORAL 41, ONCE,

ORAL

Date:11/14/01ISR Number: 3825583-1Report Type:Periodic Company Report #002#1#2001-00032 (0) Age:33 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Fatigue Health Colyte-For-Oral-Solu

Professional tion (Polyethylene

Glycol 3350) PS Schwarz Pharma Inc ORAL 2000ML, 2 IN

1 W, ORAL

Date:11/14/01ISR Number: 3825584-3Report Type:Periodic Company Report #002#2#2001-00034 (0) Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Abdominal Pain Consumer Colyte-For-Oral-Solu

Nausea tion (Polyethylene

Vomiting Glycol 3350) PS Schwarz Pharma Inc ORAL 41, ONCE,

ORAL

Date:11/14/01ISR Number: 3825585-5Report Type:Periodic Company Report #002#2#2001-00050 (0) Age:48 YR Gender:Female I/FU:I

Outcome PT

Back Pain

Constipation

Hypersensitivity

18-Apr-2007 11:25 AM Page: 21

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Pain In Extremity

Report Source Product Role Manufacturer Route Dose Duration

Consumer Colyte-Flavored-For-

Oral-Solution

(Polyethylene Glycol

3350) PS ORAL 480ML, ONCE,

ORAL

Lotrel C

Prempro C

Date:11/14/01ISR Number: 3825586-7Report Type:Periodic Company Report #002#2#2001-00053 (0) Age:68 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Chills Consumer Colyte-Flavored-For-

Oral-Solution

(Polyethylene Glycol

3350) PS ORAL 41, ONCE,

ORAL

Conjugated-Estrogens C

Medroxyprogesterone C

Lisinopril C

Date:11/14/01ISR Number: 3825587-9Report Type:Periodic Company Report #002#1#2001-00063 (0) Age:74 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hypertension Consumer Colyte-With-Flavor-P

Therapeutic Response Health acks (Cherry)

Decreased Professional (Polyethylene Glycol

3350) PS ORAL 200ML, ONCE,

ORAL

Candesartan C

Rofecoxib C

Tamsulosin C

Simethicone C

Date:11/14/01ISR Number: 3825588-0Report Type:Periodic Company Report #002#1#2001-00079(0) Age:46 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Ageusia Consumer Colyte-For-Oral-Solu

Dry Mouth Health tion (Polyethylene

Professional Glycol 3350) PS ORAL 41, ONCE,

ORAL

Tri-Leven C

Date:11/14/01ISR Number: 3825589-2Report Type:Periodic Company Report #002#2#2001-00111(1) Age:69 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hypersensitivity Consumer Peg-3350- & -Electroly

tes-For-Oral-Solutio

n (Polyethylene

Glycol 3350) PS ORAL 480ML, ONCE,

ORAL

18-Apr-2007 11:25 AM Page: 22

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Verapamil C

Digoxin C

Date:11/14/01ISR Number: 3825590-9Report Type:Periodic Company Report #002#2#2001-00118(0) Age:54 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hypersensitivity Consumer Colyte-With-Flavor-P

Vomiting acks (Flavor

Unknown)

(Polyethylene Glycol

3350) PS ORAL 2160ML, ONCE,

ORAL

Date:11/14/01ISR Number: 3825591-0Report Type:Periodic Company Report #002#1#2001-00138(0) Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Drug Effect Decreased Health Colyte-With-Flavor-P

Polyuria Professional acks (Lemon-Lime)

Company (Polyethylene Glycol

Representative 3350) PS ORAL 3800ML, ONCE,

ORAL

Date:11/14/01ISR Number: 3826405-5Report Type:Expedited (15-DaCompany Report #002#2#2001-00121 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Body Temperature Foreign Colyte-For-Oral-Solu

Increased Consumer tion (Polyethylene

Drug Effect Decreased Glycol 3350) PS ORAL 2.51, ONCE,

Malaise ORAL

Date:12/04/01ISR Number: 3834027-5Report Type:Direct Company Report # Age:58 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Blood Pressure Increased Golytely PS ORAL AS DIREC ORAL

Chills

Epistaxis

Hypothermia

Tremor

Date:12/18/01ISR Number: 3841299-XReport Type:Expedited (15-DaCompany Report #200121819FR Age:39 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Skin Exfoliation Foreign Lovenox 40 Mg/0.4 Ml

Initial or Prolonged Other Solution For

Injection PS SUBCUTANEOUS 40 MG QD SC

Didanosine (Videx) SS ORAL 1 U QD PO

Gabapentin

(Neurontin) Capsules SS ORAL 5 U PO

Stavudine (Zerit) SS ORAL 2 U PO

Macrogol 4000

(Forlax 10 G) Powder

18-Apr-2007 11:25 AM Page: 23

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

(Lyophilisate) SS ORAL 10 G QD PO 4 DAY

Atovaquone

(Wellvone) Coated

Tablets SS ORAL 500 MG PO

Date:12/26/01ISR Number: 3845066-2Report Type:Expedited (15-DaCompany Report #033-0945-M0100158 Age:39 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Cerebellar Syndrome Foreign Neurontin

Initial or Prolonged Confusional State Health (Gabapentin) PS ORAL (DAILY), PER

Disorientation Professional ORAL

Erythema (Didanosine) SS ORAL (DAILY), PER

Hallucination ORAL

Skin Exfoliation (Heparin-Fraction,

Skin Nodule Sodium Salt) SS SUBCUTANEOUS 40 MG

Toxoplasmosis (DAILY),

SUBCUTANEOUS

(Stavudine) SS ORAL (DAILY), PER

ORAL

(Macrogol) SS ORAL 10 GM

(DAILY), PER

ORAL

(Atovaquone) SS ORAL 500 MG

(DAILY), PER

ORAL

Date:01/03/02ISR Number: 3848692-XReport Type:Direct Company Report #CTU 158288 Age:66 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Anaphylactic Reaction Golitely PS ORAL 1 GAL ONCE

Initial or Prolonged ORAL

Required Aspirin C

Intervention to Atenolol C

Prevent Permanent

Impairment/Damage

Date:02/27/02ISR Number: 3874820-6Report Type:Direct Company Report #CTU 162452 Age:3 YR Gender:Male I/FU:I

Outcome PT

Other Abnormal Behaviour

Abnormal Faeces

Aggression

Balance Disorder

Constipation

Crying

Dysarthria

Emotional Disorder

Euphoric Mood

Feeling Hot

Hyperhidrosis

Inappropriate Affect

Motor Dysfunction

Movement Disorder

Obsessive Thoughts

Paraesthesia

Paranoia

18-Apr-2007 11:25 AM Page: 24

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Psychomotor Hyperactivity

Rash Maculo-Papular

Screaming Report Source Product Role Manufacturer Route Dose Duration

Skin Discolouration Miralax Peg 3350

Sleep Disorder Braintree

Speech Disorder Laboratories PS Braintree

Tic Laboratories ORAL 17GRAMS PER

DAY ORAL

Colyte C

Date:03/05/02ISR Number: 3879778-1Report Type:Direct Company Report #CTU 162783 Age:3 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Drug Toxicity Miralax Mfd By

Initial or Prolonged Electrolyte Imbalance Braintree Labs PS Braintree Labs 11 DAY

Pain

Paranoia

Tic

Tooth Disorder

Tremor

Date:03/28/02ISR Number: 3892204-1Report Type:Expedited (15-DaCompany Report #020006 Age:59 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Abdominal Distension Consumer Golytely PS ORAL 4 LITERS PO

Initial or Prolonged Asthenia

Coma

Haematochezia

Mallory-Weiss Syndrome

Mouth Haemorrhage

Nausea

Rectal Haemorrhage

Syncope

Vomiting

Date:04/17/02ISR Number: 3902896-6Report Type:Direct Company Report #CTU 165977 Age: Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Life-Threatening Anxiety Golytely PS

Hospitalization - Blood Calcium Increased

Initial or Prolonged Fatigue

Gastroenteritis Viral

Haematochezia

Haemoglobin Decreased

Insomnia

Lower Gastrointestinal

Haemorrhage

Medical Device

Complication

Overdose

Sepsis

Upper Gastrointestinal

Haemorrhage

Weight Decreased

18-Apr-2007 11:25 AM Page: 25

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:04/22/02ISR Number: 3904985-9Report Type:Expedited (15-DaCompany Report #033-0945-M0200050 Age:44 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Nightmare Foreign Neurontin

Initial or Prolonged Health (Gabapentin) PS ORAL PER ORAL

Professional Macrogol SS ORAL PER ORAL

Valproate Semisodium SS ORAL 1000 MG (500

MG, BID), PER

ORAL

Bromazepam SS ORAL (DAILY), PER

ORAL

Verapamil

Hydrochloride SS ORAL 120 (TID),

PER ORAL

Pipotiazine C

Date:04/26/02ISR Number: 3907546-0Report Type:Direct Company Report #CTU 166738 Age:71 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Life-Threatening Asthenia Polyethelene Gycol 4

Required Blood Pressure Increased Liters Generic PS ORAL 1 1/3 ORAL

Intervention to Chills

Prevent Permanent Eye Haemorrhage

Impairment/Damage Injury

Muscle Spasms

Shock

Tremor

Date:05/20/02ISR Number: 3919602-1Report Type:Expedited (15-DaCompany Report #020010 Age:5 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Renal Failure Other Fleet Enemas PS RECTAL 3 WEEK ANAL

Renal Tubular Necrosis Golytely SS 1 L L

HOUR NG

Lactulose SS ORAL 4 TBSP DAY PO

Miralax SS ORAL 34 GRAMS DAY

PO

Date:06/03/02ISR Number: 3927281-2Report Type:Direct Company Report #CTU 169412 Age:10 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Medication Error Miralax PS ONE CAPFU

DAILY

Phisohex SS

Date:06/21/02ISR Number: 3938079-3Report Type:Expedited (15-DaCompany Report #2002104581FR Age:88 YR Gender:Male I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Dizziness Foreign Xalatan(Latanoprost)

Initial or Prolonged Hypotension Health Solution, Sterile PS OPHTHALMIC OPHTHALMIC

Malaise Professional Amlor(Amlodipine

Nausea Other Besilate) SS ORAL ORAL

Syncope Triatec(Ramipril) SS ORAL ORAL

18-Apr-2007 11:25 AM Page: 26

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Nitroderm

Tts(Glyceril

Trinitrate) SS TRANSDERMAL TRANSDERMAL

Xatral(Alfuzosin) SS ORAL ORAL

Temesta (Lorazepam) SS

Zyloric(Allopurinol) SS

Speciafoldine(Folic

Acid) SS

Transipeg(Macrogol) SS

Lasilix C

Date:07/01/02ISR Number: 3943079-3Report Type:Expedited (15-DaCompany Report #PHRM2002FR01705 Age:90 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Acute Pulmonary Oedema Foreign Trileptal

Other Cardiac Failure Health (Oxcarbazepine)

Professional Tablet PS ORAL 150 MG, BID,

Company ORAL

Representative Colopeg (Sodium

Other Sulfate, Macrogol

4000) Powder SS ORAL ORAL

Lasilix Tablet C

Ace Inhibitor Nos

(No

Ingredients/Substanc

es) C

Date:07/15/02ISR Number: 3948588-9Report Type:Direct Company Report #CTU 172311 Age:73 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Acute Respiratory Golytely PS

Distress Syndrome

Cardiogenic Shock

Cor Pulmonale

Pulmonary Oedema

Date:08/01/02ISR Number: 3957982-1Report Type:Expedited (15-DaCompany Report #003#4#2002-00056(0) Age:43 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Convulsion Foreign Idrolax (Macrogol) PS ORAL 8G (10G 1 IN

Initial or Prolonged Hyponatraemia Health 1 DAY (E)),

Metastases To Central Professional ORAL

Nervous System Other Tramadol (Tramadol) C

Atarax (Hydroxyzine

Hydrochloride) C

Paracetamol

(Paracetamol) C

Date:08/01/02ISR Number: 3958149-3Report Type:Expedited (15-DaCompany Report #003#4#2002-00049 (0) Age:43 YR Gender:Male I/FU:I

Outcome PT

Life-Threatening Dyspnoea

Feeling Hot

18-Apr-2007 11:25 AM Page: 27

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Tremor

Vomiting

Report Source Product Role Manufacturer Route Dose Duration

Other Macrogol (Dose

Unknown), Unknown

(Macrogol) PS ORAL 3 SACHETS IN

12 HOURS ORAL 1 DAY

Date:08/01/02ISR Number: 3958150-XReport Type:Expedited (15-DaCompany Report #003#4#2002-00051 (0) Age:39 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Angioneurotic Oedema Other Idrolax (Macrogol) PS ORAL 10 G ORAL 104 DAY

Initial or Prolonged Drug Hypersensitivity Kardegic

(Acetylsalicylate

Lysine) SS 104 DAY

Tardyferon (Ferrous

Sulfate) SS

Plavix C

Ticlid (Ticlopidine

Hydrochloride) C

Date:08/01/02ISR Number: 3958152-3Report Type:Expedited (15-DaCompany Report #003#4#2002-00052 Age:34 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Life-Threatening Hypokalaemia Other Idrolax (Macrogol) PS ORAL 10 G ORAL

Hospitalization - Ventricular Tachycardia Propranolol C

Initial or Prolonged Heptamyl (Heptaminol

Hydrochloride) C

Librax

(Chlordiazepoxide

Hydrochloride,

Clidinium Bromide) C

Varnoline

(Desogestrel,

Ethinylestradiol) C

Date:08/05/02ISR Number: 3958887-2Report Type:Expedited (15-DaCompany Report #003#4#2002-00057 (0) Age:90 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Cystitis Idrolax (Macrogol) PS ORAL 20 G (10G 2

Initial or Prolonged Leukocytosis IN 1 DAY (S)

Neutrophil Count ) ORAL

Increased Disulone (Dapsone,

Ferrous Oxalate) C

Persantine

(Dipyridamole) C

Vesadol (Buzepide

Metiodide,

Haloperidol) C

Ciprofloxacin

(Ciprofloxacin) C

Mopral (Omeprazole) C

18-Apr-2007 11:25 AM Page: 28

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:08/05/02ISR Number: 3958888-4Report Type:Expedited (15-DaCompany Report #003#4#2002-00055 Age:83 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Depressed Level Of Idrolax (Macrogol) PS ORAL 20 G ORAL

Initial or Prolonged Consciousness Paracetamol And

Haemorrhage Intracranial Codeine SS ORAL ORAL

Haemorrhagic Stroke Paracetamol SS ORAL ORAL

Hemiplegia Valpromide SS ORAL 600 MG ORAL

Citalopram SS ORAL 20 MG ORAL

Vitamin D3

(Colecalciferol) SS ORAL 2 DF ORAL

Lorazepam SS 1 TAB

Date:09/05/02ISR Number: 3972048-2Report Type:Expedited (15-DaCompany Report #020019 Age:44 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Chromaturia Other Kadian PS ORAL 20 MG QH; PO

Fluid Retention Miralax SS ORAL 17 G 1; PO

Oliguria Phenegran C

Zanax 0.5 Mg C

Colace C

Date:09/16/02ISR Number: 3976459-0Report Type:Expedited (15-DaCompany Report #020020 Age:9 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Renal Failure Consumer Golytely PS ORAL 5 LITERS; PO

Miralax C

Laculose C

Zantac C

Metoclopramise C

Singulaire C

Albuterol C

Fleet'S Enema C

Date:09/16/02ISR Number: 3976462-0Report Type:Expedited (15-DaCompany Report #020006 Age:59 YR Gender:Male I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Abdominal Distension Consumer Golytely PS ORAL 4 LITERS PO

Initial or Prolonged Haematocrit Abnormal

Mallory-Weiss Syndrome

Syncope

Date:10/04/02ISR Number: 3988314-0Report Type:Expedited (15-DaCompany Report #863#3#2002-00001 Age:40 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Diarrhoea Foreign Idrolax (Macrogol) PS ORAL EVERY DAY

Electrolyte Imbalance Health ORAL

Sudden Death Professional Chloral Hydrate

Other (Chloral Hydrate) C

Risperidone

(Risperidone) C

Cyamemazine

(Cyamemazine) C

18-Apr-2007 11:25 AM Page: 29

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Clorazepam

(Cloazepate

Dipotassium) C

Nicotanamide

(Nicotanamide) C

Minidril

(Ethinylestradiol,

Levonorgestrel) C

Maalox (Aluminium

Hydroxide Gel,

Magnesium Hydroxide) C

Paracetamol

(Paracetamol) C

Date:10/17/02ISR Number: 3997356-0Report Type:Expedited (15-DaCompany Report #001#1#2002-00234 Age:70 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Pulmonary Oedema Health Isomol (Macrogol) PS ORAL

Professional

Date:10/17/02ISR Number: 3997383-3Report Type:Expedited (15-DaCompany Report #863#1#2002-00003 (0) Age: Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Colitis Ischaemic Health Idrolax (Macrogol) PS ORAL 3 SACHETS IN

Professional 2 DIVIDED

DOSES: 2

SACHETS 2 DAY

Date:10/18/02ISR Number: 3995837-7Report Type:Direct Company Report #CTU 179058 Age:49 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Life-Threatening Arthritis Golytely PS ORAL 4000CC X1 PO

Hospitalization - Bacterial Infection

Initial or Prolonged Condition Aggravated

Disability Diverticulum Intestinal

Haemorrhagic

Drug Withdrawal Syndrome

Haemoglobin Decreased

Weight Decreased

Date:10/24/02ISR Number: 4000375-1Report Type:Expedited (15-DaCompany Report #00212002002461 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Dehydration Health Peg-3350- & -Electroly

Initial or Prolonged Professional tes-For-Oral-Solutio

n (Polyetlene Glycol

3350 PS ORAL ORAL

18-Apr-2007 11:25 AM Page: 30

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:10/28/02ISR Number: 3999426-XReport Type:Direct Company Report #CTU 179681 Age:49 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Life-Threatening Unevaluable Event Golytely PS ORAL 4000 CC X 1

Hospitalization - PO

Initial or Prolonged

Disability

Date:10/28/02ISR Number: 4002556-XReport Type:Expedited (15-DaCompany Report #021015-PM0003-00 Age:40 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Sudden Death Foreign Tranxene

Health (Clorazepate

Professional Dipotassium) PS ORAL 10.0 MG P.O.

Other 5 TIMES/DAY

Chloral Hydrate SS ORAL P.O. 2 OR 3

SPOONS/DAY

Risperidone SS ORAL 4.0 MG P.O.

QD

Macrogol SS

Nicotinamide SS ORAL 500.0 MG P.O.

QD

Cyamemazine SS ORAL 25.0 MG P.O.

12 TIMES /

DAY

Eugynon C

Paracetamol C

Maalox C

Date:10/29/02ISR Number: 4002771-5Report Type:Expedited (15-DaCompany Report #FR9213921OCT2002 Age:91 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Eosinophil Count Health Temesta (Lorazepam,

Initial or Prolonged Increased Professional Tablet, 0) PS ORAL 1 MG 1X PER

Erythema Multiforme Other DAY, ORAL

Pemphigoid Cordarone

Pseudomonas Infection (Amiodarone, Tablet,

Staphylococcal Infection 0) SS ORAL 200 MG 1X PER

1 DAY, ORAL 1 YR

Kardegic

(Acetylsalicylate

Lysine, , 0) SS ORAL UNKNOWN 1 YR

Transipeg (Macrogol,

, 0) SS ORAL 1 DOSE 1X PER

1 DAY

Date:10/31/02ISR Number: 4003655-9Report Type:Expedited (15-DaCompany Report #FR9213921OCT2002 Age:91 YR Gender:Female I/FU:F

Outcome PT

Hospitalization - C-Reactive Protein

Initial or Prolonged Increased

Other Culture Stool Positive

Dermatitis Bullous

Eosinophil Count

Increased

18-Apr-2007 11:25 AM Page: 31

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Erythema Multiforme

Escherichia Urinary Tract

Infection Report Source Product Role Manufacturer Route Dose Duration

Pemphigoid Health Temesta (Lorazepam,

Pruritus Professional Tablet, 0) PS ORAL 1 MG 1X PER 1

Pseudomonas Infection Other DAY ORAL

Skin Lesion Cordarone

Staphylococcal Infection (Amiodarone, Tablet,

0) SS ORAL 200 MG 1X PER

1 DAY ORAL 1 YR

Kardegic

(Acetylsalicylate

Lysine, , 0) SS ORAL ORAL 1 YR

Transipeg (Macrogol,

, 0) SS ORAL 1 DOSE 1X PER

1 DAY ORAL

Date:11/05/02ISR Number: 4006823-5Report Type:Expedited (15-DaCompany Report #HQ4791024OCT2002 Age:91 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Pemphigoid Foreign Cordarone

Initial or Prolonged Pseudomonas Infection Health (Amiodarone, Tablet) PS ORAL 200 MG 1X PER

Other Staphylococcal Infection Professional 1 DAY 1 YR

Other Kardegic

(Acetylsalicylate

Lysine, ) SS ORAL 1 YR

Temesta (Lorazepam,

Tablet) SS ORAL 1 MG 1X PER 1

DAY

Transipeg (Macrogol,

) SS ORAL 1 UNIT DOSE

DAILY 1 YR

Date:11/06/02ISR Number: 4004932-8Report Type:Direct Company Report #USP 55335 Age: Gender: I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Medication Error Mirapax PS Pharmacia And Upjohn

Miralax SS Braintree

Laboratories

Date:11/08/02ISR Number: 4010823-9Report Type:Expedited (15-DaCompany Report #A0382441A Age:44 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Fatigue Foreign Aquafresh Whitening

Glossitis Consumer (Formulation

Glossodynia Unknown) (Aquafresh

Hypersensitivity Whitening) PS DENTAL TWICE A

Incision Site Haemorrhage DAY/DENTAL

Nervous System Disorder Ibuprofen C

Pain

Tongue Ulceration

Tooth Disorder

18-Apr-2007 11:25 AM Page: 32

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:11/13/02ISR Number: 4012128-9Report Type:Expedited (15-DaCompany Report #HQ4791024OCT2002 Age:91 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Eosinophilia Health Cordarone

Initial or Prolonged Erythema Multiforme Professional (Amiodarone, Tablet) PS ORAL 200 MG 1X PER

Other Pemphigoid Other 1 DAY, ORAL 1 YR

Pruritus Kardegic

Pseudomonas Infection (Acetylsalicylate

Skin Infection Lysine, ) SS ORAL ORAL 1 YR

Staphylococcal Infection Temesta (Lorazepam,

Tablet) SS ORAL 1 MG 1 X PER

1 DAY, ORAL

Transipeg (Macrogol,

) SS ORAL 1 UNIT DOSE

DAILY, ORAL 1 YR

Date:11/19/02ISR Number: 4014980-XReport Type:Expedited (15-DaCompany Report #020023 Age:65 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Diarrhoea Health Nulytely PS ORAL 4 LITERS PO

Initial or Prolonged Vomiting Professional Oxycontin C

Carisoprodol C

Ibuprofen C

Alprazolam C

Primerin C

Medroxyprogesterone C

Date:12/10/02ISR Number: 4025254-5Report Type:Expedited (15-DaCompany Report #001#1#2002-00234(1) Age:70 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Dyspnoea Health Isomol (Macrogol) PS ORAL

Pulmonary Oedema Professional

Date:12/10/02ISR Number: 4025256-9Report Type:Expedited (15-DaCompany Report #863#3#2002-00001(1) Age:40 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Diarrhoea Idrolax (Macrogol) PS ORAL (EVERY DAY)

Electrolyte Imbalance Chloral Hydrate C

Sudden Death Risperidone C

Cyamemazine C

Clorazepam

(Clorazepate

Dipotassium) C

Nicotinamide C

Minidril

(Ethinylestradiol,

Levonorgestrel) C

Maalox (Aluminium

Hydroxide Gel,

Magnesium Hydroxide) C

Paracetamol C

18-Apr-2007 11:25 AM Page: 33

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:12/17/02ISR Number: 4027410-9Report Type:Expedited (15-DaCompany Report #863#1#2002-00003 (2) Age:74 YR Gender:Male I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Colitis Ischaemic Health Idrolax (Macrogol) PS ORAL 3 SACHETS IN

Professional 2 DIVIDED

DOSES: 2

SACHETS, ORAL 2 DAY

Date:12/24/02ISR Number: 4033687-6Report Type:Expedited (15-DaCompany Report #020030 Age:92 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Cardiac Failure Consumer Miralax PS ORAL 17 G 1X PO;

Colon Cancer ONE DOSE

Disease Progression Lanoxin C

Imdur C

Cardigem Cp C

Accupril C

Ammodarone C

Coumadin C

Date:12/31/02ISR Number: 4037925-5Report Type:Expedited (15-DaCompany Report #003#4#2002-00049 Age:43 YR Gender:Male I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Life-Threatening Dyspnoea Foreign Macrogol (Dose

Feeling Hot Health Unknown) PS ORAL 1 IN 4 HR. 1 DAY

Tremor Professional

Vomiting Other

Date:01/17/03ISR Number: 4044591-1Report Type:Expedited (15-DaCompany Report #863#3#2003-00001(0) Age:48 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Angioneurotic Oedema Other Idrolax(Macrogol) PS 1/2 SACHET 1 DAY

Initial or Prolonged Serum Sickness

Vasculitis

Date:01/30/03ISR Number: 4050795-4Report Type:Expedited (15-DaCompany Report #863#3#2003-00002 Age:75 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Angioneurotic Oedema Idrolax (Macrogol) PS ORAL 20 G ORAL 1 DAY

Initial or Prolonged Drug Hypersensitivity Augmentin

(Clavulanic Acid,

Amoxicillin

Trihydrate) C

Trihexyphenidyl

Hydrochloride

(Trihexyphenidyl

Hydrochloride) C

Levomepromaize

(Levomepromazine) C

Clorazepate

Dipotassium

(Clorazepate

Dipotassium) C

18-Apr-2007 11:25 AM Page: 34

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Paracetamol

(Paracetamol) C

Potassium Chloride

(Potassium Chloride) C

Date:02/14/03ISR Number: 4056218-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12176863 Age:80 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Confusional State Health Aprovel Tabs 75 Mg PS Bristol-Myers Squibb

Initial or Prolonged Hallucination Professional Company ORAL

Densical SS ORAL

Tardyferon B9 SS ORAL

Aldactone 50 SS ORAL 25 mg x 2/d

Eupantol SS ORAL 16 DAY

Movicol SS ORAL

Speciafoldine SS ORAL

Mopral C

Morphine C

Date:02/14/03ISR Number: 4060542-8Report Type:Expedited (15-DaCompany Report #003#1#2003-00013 Age:74 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Vomiting Foreign Idrolax (Macrogol) PS ORAL ORAL 2 DAY

Health

Professional

Date:02/19/03ISR Number: 4060112-1Report Type:Expedited (15-DaCompany Report #002#2#2003-00067 Age:79 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Ascites Foreign Colyte-For-Oral-Solu

Initial or Prolonged Blood Albumin Decreased Consumer tion (Polyethylene

Procedural Complication Glycol 3350) PS ORAL ORAL

Nifedipine C

Date:02/27/03ISR Number: 4067537-9Report Type:Expedited (15-DaCompany Report #003#1#2003-00013(1) Age:74 YR Gender:Male I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Vomiting Health Idrolax (Macrogol) PS ORAL 2 DAY

Professional

Date:03/03/03ISR Number: 4069538-3Report Type:Expedited (15-DaCompany Report #2003-02-2243 Age:85 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Respiratory Distress Foreign Clarityne Tablets

Initial or Prolonged Health (Loratadine)

Professional (Like Claritin) PS ORAL 1 TABLET QD

Other ORAL

Debridat SS ORAL 3 QD ORAL

Forlax (Macrogol) SS ORAL 2 QD ORAL

Ornithine Oxogulrate SS ORAL 2 QD ORAL

Tercian C ORAL 2 QD ORAL

18-Apr-2007 11:25 AM Page: 35

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Vitamin D C

Nitriderm Tts C

Fonzylane C

Mopral (Omeprazole) C

Cordarone C

Lasilix C

Plavix (Clopidogrel) C

Date:03/12/03ISR Number: 4072212-0Report Type:Direct Company Report #USP 55576 Age:5 YR Gender: I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Faecaloma Peg 3350 (Peg

Intestinal Obstruction Electrolyte

Medication Error Solution) PS SOLUTION

Pyrexia Lactulose SS SYRUP

Renal Tubular Necrosis Miralex

(Polyethylene

Glycol) SS Braintree

Date:03/13/03ISR Number: 4075825-5Report Type:Expedited (15-DaCompany Report #2003008830 Age:90 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Blood Potassium Increased Foreign Atarax (Tablet)

Initial or Prolonged Dehydration Health (Hydroxyzine

Drug Interaction Professional Hydrochloride) PS ORAL 50 MG (25 MG

Eschar TWICE DAILY)

Heart Rate Irregular ORAL

Renal Failure Acute Potassium Chloride SS ORAL (TWICE

DAILY), ORAL

Captopril SS ORAL 100 MG

(DAILY), ORAL

Furosemide SS ORAL 40 MG

(DAILY), ORAL

Pipamperone SS ORAL (TWICE

DAILY), ORAL

Macrogol SS ORAL 10 GRAM

(DAILY), ORAL

Isosorbide

Mononitrate C

Fluindione C

Propofan C

Date:03/14/03ISR Number: 4076910-4Report Type:Expedited (15-DaCompany Report #HQWYE868305MAR03 Age:97 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Respiratory Distress Foreign Cordarone

Health (Amiodarone, Tablet) PS ORAL 200 MG 1X PER

Professional 1 DAY ORAL

Other Efferalgan

(Paracetamol, ) SS ORAL 500 MG 3X PER

1 DAY ORAL

Forlax (Macrogol, ) SS ORAL 10 G 1X PER 1

DAY ORAL

Nitriderm Tts

(Glyceryl

18-Apr-2007 11:25 AM Page: 36

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Trinitrate, ) SS TRANSDERMAL 5 MG 1X PER 1

DAY

TRANSDERMAL

Previscan

(Fluindione, ) SS ORAL 5 MG 1X PER 1

DAY ORAL

Theralen

(Alimemazine

Tartrate, ) SS ORAL 5 UNIT 1X PER

1 DAY ORAL

Date:03/14/03ISR Number: 4076925-6Report Type:Expedited (15-DaCompany Report #863#3#2003-00003 (1) Age:97 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Bronchopneumonia Other Idrolax (Macrogol) PS ORAL 10 G ORAL

Initial or Prolonged Respiratory Distress Theralene

(Alimemazine

Tartrate) C

Previscan

(Fluindione) C

Efferalgan (Ascorbic

Acid, Paracetamol,

Sodium Citrate) C

Nitriderm (Glyceryl

Trinitrate) C

Cordarone

(Amiodarone

Hydrochloride) C

Date:03/14/03ISR Number: 4076926-8Report Type:Expedited (15-DaCompany Report #863#3#2003-00005 (0) Age:85 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Respiratory Distress Other Idrolax (Macrogol) PS ORAL 2 SACHETS

Initial or Prolonged ORAL

Debridat

(Trimebutine

Maleate) C

Tercian

(Cyamemazine) C

Cetornan (Ornithine

Oxoglurate) C

Claritine

(Loratadine) C

Calcidose Vitamin D

(Ergocalciferol) C

Nitriderm Tts 10

(Glyceryl

Trinitrate) C

Fonzylane

(Buflomedil

Hydrochloride) C

Mopral (Omeprazole) C

Cordarone

(Amiodarone

Hydrochloride) C

Lasilix (Furosemide) C

Plavix C

18-Apr-2007 11:25 AM Page: 37

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:04/01/03ISR Number: 4085511-3Report Type:Expedited (15-DaCompany Report #863#8#2003-00006(1) Age:17 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Large Intestinal Literature Idrolax (Macrogol) PS ORAL ONCE ORAL

Initial or Prolonged Haemorrhage Prednisone

Other Medication Error (Prednisone) C

Shock Haemorrhagic Salofalk

(Aminosalicylic

Acid) C

Entizol

(Metronidazole) C

Entcort Enema

(Budesonide) C

Date:04/01/03ISR Number: 4085512-5Report Type:Expedited (15-DaCompany Report #863#1#2003-00004 (2) Age:25 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Drug Hypersensitivity Health Idrolax (Macrogol) PS ORAL 1 SACHET ORAL 1 DAY

Initial or Prolonged Professional

Date:04/03/03ISR Number: 4087155-6Report Type:Direct Company Report #CTU 190079 Age:9 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Medication Error Golytely PS ORAL 5 LITERS PO

Renal Failure Miralax C

Laculose C

Zantac C

Metoclopramise C

Singulaire C

Albuterol C

Fleet'S Enema C

Date:04/03/03ISR Number: 4087156-8Report Type:Direct Company Report #CTU 190078 Age:5 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Medication Error Fleet Enemas PS RECTAL 3 WEEK ANAL

Renal Failure Golytely SS 1 L L HOUR NG

Renal Tubular Necrosis Lactulose SS ORAL 4 TBSP DAY PO

Miralax SS ORAL 34 GRAMS DAY

PO

Date:04/04/03ISR Number: 4088052-2Report Type:Direct Company Report #CTU 190284 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Life-Threatening Blood Potassium Decreased Golytely PS 4 L OVER 3

Hospitalization - Ventricular Fibrillation HRS

Initial or Prolonged

18-Apr-2007 11:25 AM Page: 38

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:04/10/03ISR Number: 4088634-8Report Type:Direct Company Report #CTU 190586 Age:73 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Convulsion Mirapex 0.5 Mg

Medication Error Pharmacia Upjohn PS Pharmacia Upjohn

Miralax Braintree SS Braintree

Date:04/10/03ISR Number: 4091229-3Report Type:Direct Company Report #CTU 190695 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Life-Threatening Blood Potassium Golytely PS 4 L OVER 3

Hospitalization - Ventricular Fibrillation HOURS

Initial or Prolonged Colace C

Metamucil C

Toprol Xl C

Date:04/14/03ISR Number: 4094724-6Report Type:Expedited (15-DaCompany Report #002#2#2003-00067 (1) Age:79 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Ascites Foreign Colyte-For-Oral-Solu

Hospitalization - Hypoproteinaemia Consumer tion (Polyethylene

Initial or Prolonged Glycol 3350) PS ORAL , ORAL

Nifedipine C

Date:04/30/03ISR Number: 4105917-3Report Type:Expedited (15-DaCompany Report #030008 Age: Gender: I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Blood Sodium Abnormal Literature Golytely PS ORAL 4 LITERS PO

Hospitalization -

Initial or Prolonged

Date:05/05/03ISR Number: 4108366-7Report Type:Expedited (15-DaCompany Report #003#1#2003-00013(2) Age:74 YR Gender:Male I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Cardiac Failure Health Idrolax (Macrogol) PS ORAL 2 DAY

Hospitalization - General Physical Health Professional Lactulose

Initial or Prolonged Deterioration (Lactulose) C

Nausea

Vomiting

Date:05/08/03ISR Number: 4110041-XReport Type:Expedited (15-DaCompany Report #003#1#2003-00013(3) Age:74 YR Gender:Male I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Cardiac Failure Health Idrolax (Macrogol) PS ORAL 10 G ORAL 2 DAY

Hospitalization - Vomiting Professional Lactulose

Initial or Prolonged (Lactulose) C

Ramipril (Ramipril) C

Naftidrofuryl

Oxalate

(Naftidrofuryl

Oxalate) C

18-Apr-2007 11:25 AM Page: 39

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Metoclopramide

Hydrochloride

(Metoclopramide

Hydrochloride) C

Date:05/08/03ISR Number: 4110043-3Report Type:Expedited (15-DaCompany Report #863#3#2003-00007(0) Age:73 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Convulsion Idrolax (Macrogol) PS ORAL 2 EACHETE/DAY

Initial or Prolonged ORAL

Baclofen (Baclofen) C

Insulin (Insulin

Human) C

Insulin Lispro C

Donezepil C

Atorvastatin C

Date:06/02/03ISR Number: 4122710-6Report Type:Expedited (15-DaCompany Report #863#3#2003-00009 Age:78 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Abnormal Behaviour Idrolax (Macrogol) PS ORAL 30 G

Initial or Prolonged Cerebrovascular Accident Lipanthyl

Condition Aggravated (Fenofibrate) C

Nervous System Disorder Tercian

(Cyamemazine) C

Imovane (Zopiclone) C

Diffu K (Potassium

Chloride) C

Aspegic 250

(Acetylsalicylic

Acid) C

Date:06/02/03ISR Number: 4122711-8Report Type:Expedited (15-DaCompany Report #863#3#2003-00008 Age:86 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Linear Iga Disease Idrolax (Macrogol) PS ORAL 10 G

Initial or Prolonged Pulmicort Turbohaler

(Budesonide) C

Bricanyl

(Terbutaline

Sulfate) C

Efferalgan (Ascorbic

Acid, Paracetamol,

Sodium Citrate) C

Mopral (Omeprazole) C

Zyrtek (Cetirizine

Hydrochloride) C

Haldol (Haloperidol) C

Medrol

(Methylprednisolone) C

18-Apr-2007 11:25 AM Page: 40

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:06/09/03ISR Number: 4126519-9Report Type:Expedited (15-DaCompany Report #863#3#2003-00010 Age:50 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Arrhythmia Idrolax (Macrogol) PS ORAL 20 G 3 WK

Cardio-Respiratory Arrest Colchicine

Cardiomyopathy (Colchicine) C

Coma Primperan

Ejection Fraction (Metoclopramide) C

Decreased Xanax (Alprazolam) C

Gastrointestinal Disorder Seropram

Loss Of Consciousness (Citaloprami

Mydriasis Hydrobromidum) C

Shock Depakote (Valproate

Semisodium) C

Hept-A-Myl

(Heptaminol

Hydrochloride) C

Dogmatil (Sulpiride) C

Di-Antalvic

(Dextropropoxyphene

Hydrochloride,

Paracetamol) C

Date:06/11/03ISR Number: 4128094-1Report Type:Expedited (15-DaCompany Report #03P-056-0217775-00 Age:52 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Arrhythmia Foreign Depakote (Divalproex

Required Blood Pressure Abnormal Health Sodium) (Divalproex

Intervention to Cardio-Respiratory Arrest Professional Sodium) PS ORAL 500 MG, 1 IN

Prevent Permanent Cardiomyopathy Company 1 D, ORAL

Impairment/Damage Coma Representative Metoclopramide SS ORAL SEE IMAGE

Loss Of Consciousness Colchicine SS ORAL 0.5 MG, 2 IN

Shock 1 D, ORAL

Alprazolam SS ORAL 0.5 MG,3 IN

1D,ORAL

Macrogol SS ORAL 10GM, 2 IN 1

D, ORAL

Citalopram

Hydrobromide SS INTRAVENOUS 20-40

MILLIGRAMS,

INTRAVENOUS

Sulpiride C

Heptaminol

Hydrochloride C

Aporex C

Date:06/12/03ISR Number: 4129157-7Report Type:Expedited (15-DaCompany Report #PHNU2003DE01890 Age:68 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Infection Foreign Voltaren(Diclofenac

Plasmacytoma Health Sodium)

Pneumonia Professional Enteric-Film-Coated

Rhabdomyolysis Other Tablet PS ORAL 75 MG, BID,

ORAL

Pantozol(Pantoprazol

e Sodium) SS ORAL 40 MG, QD,

ORAL

18-Apr-2007 11:25 AM Page: 41

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Saroten Bayer

Vital (Amitriptyline

Hydrochloride) SS Bayer Vital ORAL 25 MG, QD,

ORAL

Acc (Acetylcysteine) SS ORAL 600 MG, QD,

ORAL

Ass

"Ct--Arzneimittel

(Acetylsalicylic

Acid) SS Ct-Arzneimittel ORAL 100 MG, QD,

ORAL

Movicol(Macrogol) SS ORAL 1 DF, BID,

ORAL

Heparin(Heparin) SS SUBCUTANEOUS 7500 IU, BID,

SUBCUTANEOUS

Allopurinol(Allopuri

nol) SS ORAL 300 MG, QD,

ORAL

Durogesic(Fentanyl) SS TRANSDERMAL 75 UG,

TRANSDERMAL

Zienam (Imipenem,

Cilastin Sodium) SS INTRAVENOUS 0.05 G, TID,

INTRAVENOUS

Date:06/13/03ISR Number: 4128771-2Report Type:Direct Company Report #CTU 195765 Age:11 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Petechiae Polyethylene Glycol

(Nulytely) PS NASAL 500ML PER

HOUR NG

Date:06/17/03ISR Number: 4130736-1Report Type:Direct Company Report #CTU 196022 Age:56 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Life-Threatening Anaphylactic Reaction Hyperosmotic

Hospitalization - Laxatives (Colon

Initial or Prolonged Electrolyte Lavage

Required Powder) PS 8 OZ EVERY 15

Intervention to MIN UNTIL

Prevent Permanent STOOLS CLEAR

Impairment/Damage OR GALLON

CONSUMED

Acetaminophen 325mg

Tab C

Atenolol 50mg Tab C

Cyproheptadine Hcl

4mg Tab C

Docusate Na 100mg

Cap C

Furosemide 20mg Tab C

Hydrochlorothiazide

25mg Tab C

Lansoprazole 30mg Sa

Cap C

Levothyroxine Na

(Synthroid) 0.1mg

Tab C

18-Apr-2007 11:25 AM Page: 42

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Potassium Chloride

8meq Sa Tab C

Simvastatin 20mg Tab C

Venlafaxine Hcl

150mg *Xr* Cap C

Quetiapine Fumarate

100mg Tab C

Quinine Sulfate

325mg Cap C

Date:06/17/03ISR Number: 4131682-XReport Type:Expedited (15-DaCompany Report #03P-056-0217775-00 Age:52 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Abdominal Pain Foreign Depakote (Divalproex

Required Arrhythmia Health Sodium) (Divalproex

Intervention to Cardio-Respiratory Arrest Professional Sodium) PS ORAL 500 MG, 1 IN

Prevent Permanent Cardiomyopathy Company 1 D, ORAL

Impairment/Damage Coma Representative Metoclopramide SS ORAL AS REQUIRED,

Ejection Fraction OAL

Decreased Colchicine SS ORAL 0.5 MG, 2 IN

Electroencephalogram 1 D, ORAL

Abnormal Alprazolam SS ORAL 0.5 MG, 3 IN

Familial Mediterranean 1 D, ORAL

Fever Macrogol SS ORAL 10 GM, 2 IN 1

Gastrointestinal Disorder D, ORAL

Shock Citalopram

Vomiting Hydrobromide SS INTRAVENOUS 20-40

MILLIGRAMS,

INTRAVENOUS

Sulpiride C

Heptaminol

Hydrochloride C

Aporex C

Date:06/26/03ISR Number: 4136968-0Report Type:Expedited (15-DaCompany Report #EMADSS2003003509 Age:86 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Face Oedema Foreign Haldol (Haloperidol)

Initial or Prolonged Herpes Virus Infection Health Solution PS ORAL 0.9 MG, 1 IN

Linear Iga Disease Professional 1 DAY, ORAL

Oral Soft Tissue Disorder Efferalgan

(Paracetamol) SS ORAL , IN 1 AS

NECESSARY,

ORAL

Mopral (Omeprazole)

Tablets SS ORAL 1 DOSE(S), 1

IN 1 DAY,

ORAL

Forlax (Macrogol) SS ORAL 1 DOSE(S), 1

IN 1 DAY,

ORAL

Zyrtec (Cetirizine

Hydrochloride) SS ORAL 10 MG, 1 IN 1

DAY, ORAL

Medrol

(Methylprednisolone) SS ORAL 8 MG, 1 IN 1

DAY, ORAL

18-Apr-2007 11:25 AM Page: 43

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Pulmicort

(Budesonide) SS RESPIRATORY

(INHALATION) RESPIRATORY

(INHALATION)

Bricanyl

(Terbutaline

Sulfate) SS RESPIRATORY

(INHALATION) RESPIRATORY

(INHALATION)

Date:06/26/03ISR Number: 4137615-4Report Type:Expedited (15-DaCompany Report #030013 Age:60 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Haematemesis Consumer Orange Nulytely PS

Nausea Zocor C

Pharyngolaryngeal Pain Synthroid C

Vomiting Actonel C

Date:07/01/03ISR Number: 4140846-0Report Type:Expedited (15-DaCompany Report #2003018681 Age:86 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Face Oedema Foreign Zyrtec (Tablets)

Initial or Prolonged Herpes Virus Infection Health (Cetirizine) PS ORAL 10 MG

Linear Iga Disease Professional (DAILY), ORAL

Oral Mucosal Disorder Paracetamol

(Paracetamol) SS ORAL UNKNOWN

(PRN), ORAL

Omeprazole

(Omeprazole) SS ORAL 10 MG,

(DAILY), ORAL

Macrogol (Macrogol) SS ORAL 10 GRAM

(DAILY), ORAL

Haloperidol

(Haloperidol) SS ORAL ORAL

Methylprednisoloe

(Methylprednisolone) SS ORAL 8 MG (DAILY),

ORAL

Budesonide

(Budesonide) C

Terbutaline Sulfate

(Terbutaline

Sulfate) C

Date:07/07/03ISR Number: 4144286-XReport Type:Expedited (15-DaCompany Report #030013 Age:60 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Haematemesis Consumer Orange Nulytely PS

Nausea Zocor C

Pharyngolaryngeal Pain Synthroid C

Vomiting Actonel C

18-Apr-2007 11:25 AM Page: 44

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:07/23/03ISR Number: 4152309-7Report Type:Direct Company Report #CTU 198468 Age:3 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Pancreatitis Peg-Asparginase 1550

Initial or Prolonged Units PS INTRAVENOUS X1 IM

Date:07/28/03ISR Number: 4156268-2Report Type:Direct Company Report #USP 50539 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Eye Burns Mycocide Ns PS Woodward SOLUTION

Medication Error Hypotears SS Cibavision SOLUTION

Date:07/30/03ISR Number: 4158962-6Report Type:Expedited (15-DaCompany Report #PHRM2003FR01808 Age:81 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Epistaxis Nitriderm Tts PS Novartis Sector:

Initial or Prolonged International Normalised Pharma TRANSDERMAL 10 mg/day

Ratio Digoxin "Nativelle" SS ORAL 1 tab/day

Levothyrox SS ORAL 50 A?g/day

Lasilix SS ORAL 40 mg/day

Vastarel "Biopharma" SS ORAL 40 mg/day

Stilnox SS ORAL 1 tab/day

Deroxat SS ORAL 1 tab/day

Equanil SS ORAL 2 tab/day

Transipeg SS ORAL

Doliprane SS ORAL 3 g/day

Diffu K SS ORAL 2 caps/day

Mini-Sintrom SS ORAL 1 mg day 1, 2

mg day 2

Date:07/30/03ISR Number: 4160635-0Report Type:Expedited (15-DaCompany Report #863#1#2003-00011(0) Age:72 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Disability Balance Disorder Health Idrolax (Macrogol) PS ORAL 20 TO 30G

Blood Cortisol Increased Professional DAILY 2 MON

Gait Disturbance Gabapentin

Hyponatraemia (Gabapentin) C

Nervous System Disorder Phenobarbital

(Phenobarbital) C

Date:08/01/03ISR Number: 4163115-1Report Type:Expedited (15-DaCompany Report #030018 Age:70 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Blood Sodium Health Golytely PS

Initial or Prolonged Coma Professional Neurontin C

Convulsion Premarin C

Thyroid Medication C

18-Apr-2007 11:25 AM Page: 45

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:08/11/03ISR Number: 4167487-3Report Type:Expedited (15-DaCompany Report #863#1#2003-00011 Age:72 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Disability Balance Disorder Health Idrolax (Macrogol) PS ORAL 20 TO 30G

Blood Cortisol Increased Professional DAILY 2 MON

Gait Disturbance Gabapentin

Hyponatraemia (Gabapentin) C

Phenobarbital

(Phenobarbital) C

Date:08/11/03ISR Number: 4167819-6Report Type:Expedited (15-DaCompany Report #002#2#2003-00402 Age:66 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Blood Pressure Increased Consumer Colyte-With-Flavor-P

Initial or Prolonged Bruxism acks

Other Contusion (Flavor-Unknown)

Convulsion (Polyethylene Glycol

Joint Dislocation 3350) PS ORAL ORAL

Muscle Contractions Hormones C

Involuntary Cetirizine C

Respiratory Arrest

Sinusitis

Upper Limb Fracture

Date:08/12/03ISR Number: 4169103-3Report Type:Expedited (15-DaCompany Report #003#1#2003-00103 Age: Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Renal Failure Foreign Idrolax (Macrogol) PS ORAL ORAL

Health

Professional

Date:08/13/03ISR Number: 4169352-4Report Type:Expedited (15-DaCompany Report #030022 Age:79 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Aspiration Health Golytely PS 4 LITERS NG

Initial or Prolonged Intestinal Obstruction Professional

Lung Infiltration

Pulmonary Oedema

Vomiting

Date:08/13/03ISR Number: 4169354-8Report Type:Expedited (15-DaCompany Report #030023 Age:4 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Abnormal Behaviour Consumer Miralax PS ORAL 17 GRAMS

Crying VARIED PO

Diarrhoea

Faecal Incontinence

Irritability

Lethargy

18-Apr-2007 11:25 AM Page: 46

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:08/13/03ISR Number: 4169357-3Report Type:Expedited (15-DaCompany Report #030021 Age:56 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Blood Urine Consumer Miralax PS ORAL 0.5 TSPN, PO 10 MON

Penis Disorder Lipitor C

Seravent C

Aereovid C

Nasilide C

Date:08/18/03ISR Number: 4172197-2Report Type:Expedited (15-DaCompany Report #002#2#2003-00417 Age: Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Blood Pressure Decreased Consumer Colyte-Flavored-For-

Erythema Oral-Solution

Feeling Cold (Polyethylene Glycol

Shock 3350) PS ORAL 1 ONCE, ORAL

Tremor

Urticaria

Date:08/25/03ISR Number: 4177713-2Report Type:Expedited (15-DaCompany Report #003#1#2003-00103 Age: Gender:Male I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Life-Threatening Blood Potassium Decreased Foreign Idrolax (Macrogol) PS ORAL 20G SINGLE

Renal Failure Health DOSE IN 250ML

Ventricular Tachycardia Professional ORAL 1 DAY

Atorvastatin C

Solpadol (Codeine

Phosphate,

Paracetamol) C

Rampiril (Ramipril) C

Felodipine

(Felodipine) C

Frusemide

(Furosemide) C

Allopurinol

(Allopurinol) C

Date:08/25/03ISR Number: 4178197-0Report Type:Expedited (15-DaCompany Report #002#2#2003-00402 (2) Age:66 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Blood Pressure Increased Consumer Colyte-With-Flavor-P

Initial or Prolonged Confusional State acks

Other Contusion (Flavor-Unknown)

Convulsion (Polyethylene Glycol

Depression 3350) PS ORAL ORAL

Disturbance In Attention Estrogens C

Dyskinesia Levothyroxine C

Feeling Abnormal Norethindrone C

Incoherent Valdecoxib C

Joint Dislocation Acetylsalicylic-Acid C

Muscle Contractions

Involuntary

Paraesthesia

Sinusitis

Upper Limb Fracture

18-Apr-2007 11:25 AM Page: 47

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:08/26/03ISR Number: 4179496-9Report Type:Expedited (15-DaCompany Report #030021 Age:56 YR Gender:Male I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Blood Urine Present Consumer Miralax PS ORAL 0.5 TSPN. PO 10 MON

Capillary Disorder Lipitor C

Seravant C

Aerevid C

Nasilide C

Date:09/08/03ISR Number: 4185829-XReport Type:Expedited (15-DaCompany Report #863#3#2003-00012(0) Age:84 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Agitation Other Idrolax (Macrogol) PS ORAL

Initial or Prolonged Dyspnoea Medronizine

Hyperhidrosis (Meprobamate,

Hypoxia Aceprometazine) C

Intercostal Retraction Kardegic

Somnolence (Acetylsalicylate

Lysine) C

Nitriderm Tts

(Glyceryl

Trinitrate) C

Risperdal

(Risperidone) C

Date:09/09/03ISR Number: 4188150-9Report Type:Expedited (15-DaCompany Report #003#1#2003-00121(0) Age:80 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Obstruction Health Idrolax (Macrogol) PS

Professional

Date:09/12/03ISR Number: 4189887-8Report Type:Expedited (15-DaCompany Report #030025 Age:79 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Medication Error Health Golytely PS 4 LITERS NG

Initial or Prolonged Professional

Date:09/15/03ISR Number: 4190521-1Report Type:Expedited (15-DaCompany Report #002#2#2003-00402 Age:66 YR Gender:Female I/FU:F

Outcome PT

Hospitalization - Blood Pressure Increased

Initial or Prolonged Bruxism

Other Confusional State

Contusion

Convulsion

Depression

Disturbance In Attention

Feeling Abnormal

Incoherent

Joint Dislocation

Movement Disorder

Muscle Contractions

Involuntary

18-Apr-2007 11:25 AM Page: 48

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Muscle Disorder

Paraesthesia

Respiratory Arrest Report Source Product Role Manufacturer Route Dose Duration

Sinusitis Consumer Colyte-With-Flavor-P

Speech Disorder Health acks

Upper Limb Fracture Professional (Flavor-Unknown)

(Polyethylene Glycol

3350) PS ORAL ORAL

Estrogens C

Cetirizine C

Levothyroxine C

Norethindrone C

Valdecoxib C

Acetylasalicylic-Aci

d C

Date:09/22/03ISR Number: 4195885-0Report Type:Expedited (15-DaCompany Report #2003160893FR Age:50 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Arrhythmia Foreign Xanax (Alprazolam)

Blood Pressure Abnormal Health Tablet PS ORAL 0.5 MG, TID,

Cardiac Amyloidosis Professional ORAL

Cardiac Arrest Seropram(Citalopram

Cardiac Disorder Hydrobromide) SS ORAL 40 MG/DAY,

Cardiomegaly ORAL

Coma Colchimax

Ejection Fraction (Dicycllverine

Decreased Hydrochloride,

Mydriasis Colchicine) SS ORAL 0.5 MG/DAY,

Pupils Unequal ORAL

Pyrexia Primperan(Metoclopra

Respiratory Arrest mide) SS ORAL ORAL

Shock Forlax (Macrogol) SS ORAL ORAL

Depakote (Valproate

Semisodium) SS ORAL 500 MG/DAY,

ORAL

Equanil

(Meprobamate) C

Date:09/22/03ISR Number: 4196173-9Report Type:Expedited (15-DaCompany Report #863#3#2003-00010 Age:50 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Arrhythmia Idrolax (Macrogol) PS ORAL 20 G, ORAL 3 WK

Cardiac Amyloidosis Colchicine C

Cardiac Arrest Primperan

Cardiomyopathy (Metoclopramide) C

Electroencephalogram Xanax (Alprazolam) C

Abnormal Seropram (Citalopram

Loss Of Consciousness Hydrobromidum) C

Mydriasis Depakote (Valproate

Respiratory Arrest Semisodium) C

Shock Hept-A-Myl

(Heptaminol

Hydrochloride) C

Dogmatil (Sulpiride) C

Di-Antalvic

(Dextropropoxyphene

18-Apr-2007 11:25 AM Page: 49

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Hydrochloride,

Paracetamol) C

Date:09/22/03ISR Number: 4196174-0Report Type:Expedited (15-DaCompany Report #863#3#2003-00013 Age:49 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Anaphylactic Reaction Idrolax (Macrogol) PS ORAL 10 G, ORAL

Initial or Prolonged Circulatory Collapse Vibramycine

Erythema (Doxycycline) C

Zovirax (Aciclovir) C

Solu-Medrol

(Methylprednisolone) C

Cortancyl

(Prednisone) C

Date:09/22/03ISR Number: 4196175-2Report Type:Expedited (15-DaCompany Report #863#3#2003-00014 Age:79 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Leukocytoclastic Idrolax (Macrogol) PS ORAL 10 G (10G 1

Initial or Prolonged Vasculitis IN 1 DAY(S)),

ORAL 393 DAY

Ascorbic Acid C

Fenofibrate C

Paracetamol C

Novomix (Insulin

Aspart) (Insulin

Injection, Biphasic) C

Risperidone C

Zopiclone C

Date:09/23/03ISR Number: 4195473-6Report Type:Direct Company Report #CTU 202353 Age:70 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Asthenia Balanced Lavage

Dizziness Solution

Hypoglycaemia (Colonscopy Prep) PS 4 L (250 ML Q

Nausea 15 MIN START

6 PM B/F

PROCEDURE)

Ammonium Lactate C

Hct/ Pramoxine Cream C

Anusol C

Atenolol C

Sennosides C

Metformin C

Oxybutinin C

Insulin C

Ranitidine C

Metoclopramide C

Lisinopril C

Lansoprazole C

Isosorbide Dinitrate C

Aspirin C

Terazosin C

Ntg C

Furosemide C

18-Apr-2007 11:25 AM Page: 50

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Mg Citrate C

Date:10/01/03ISR Number: 4204319-9Report Type:Expedited (15-DaCompany Report #03P-056-0217775-00 Age:50 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Arrhythmia Foreign Depakote (Divalproex

Required Blood Pressure Abnormal Health Sodium) (Divalproex

Intervention to Cardiac Amyloidosis Professional Sodium) PS ORAL 500 MG, 1 IN

Prevent Permanent Cardio-Respiratory Arrest Company 1 D, ORAL

Impairment/Damage Cardiomyopathy Representative Metoclopramide SS ORAL SEE IMAGE

Coma Colchicine SS ORAL 0.5 MG, 2 IN

Depression 1 D, ORAL

Hypertrophy Alprazolam SS ORAL 0.5 MG, 3 IN

Loss Of Consciousness 1 D, ORAL

Shock Macrogol SS ORAL 10 GM, 2 IN 1

Vomiting D, ORAL

Citalopram

Hydrobromide SS SEE IMAGE

Sulpiride C

Heptaminol

Hydrochloride C

Aporex C

Date:10/27/03ISR Number: 4220554-8Report Type:Expedited (15-DaCompany Report #001#1#2003-00212 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Diverticulum Health Isomol (Macrogol) PS ORAL 1 SACHETE A

Life-Threatening Extravasation Professional DAY ORAL

Large Intestine

Perforation

Date:11/06/03ISR Number: 4230463-6Report Type:Expedited (15-DaCompany Report #030030 Age:52 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Life-Threatening Anaphylactic Reaction Health Miralax PS ORAL 255 GRAMS PO

Professional Lupron Injections C

Zanax C

Elavil C

Ambien C

Viox C

Singulair/Alupent C

Date:11/10/03ISR Number: 4234533-8Report Type:Expedited (15-DaCompany Report #002#2#2003-00417 Age:62 YR Gender:Male I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Life-Threatening Anaphylactic Shock Consumer Colyte-Flavored-For-

Hospitalization - Blood Pressure Decreased Oral-Solution PS ORAL 1 ONCE, ORAL

Initial or Prolonged Feeling Cold Metoprolol C

Shock

Tremor

Urticaria

18-Apr-2007 11:25 AM Page: 51

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:12/01/03ISR Number: 4243914-8Report Type:Direct Company Report #CTU 207046 Age:87 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Aspiration Golytely PS

Asthenia

Cardiac Disorder

Diarrhoea

Pneumonia

Renal Disorder

Vomiting

Date:12/08/03ISR Number: 4248553-0Report Type:Expedited (15-DaCompany Report #030034 Age:52 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Dizziness Consumer Golytely PS ORAL 4 LITERS PO

Hypersensitivity High Blood Pressure

Muscle Spasms Med C

Diabetes Med C

Tylenol 3 C

Flexeril C

Date:12/11/03ISR Number: 4250854-7Report Type:Expedited (15-DaCompany Report #002#2#2003-00417(2) Age:62 YR Gender:Male I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Life-Threatening Anaphylactic Shock Consumer Colyte-Flavored-For-

Hospitalization - Chest Pain Health Oral-Solution

Initial or Prolonged Feeling Abnormal Professional (Polyethylene Glycol

Feeling Cold 3350) PS ORAL 1ONCE, ORAL

Tremor Metoprolol-Succinate C

Nitroglycerin C

Valsartan C

Atorvastatin-Calcium C

Clopidogrel C

Mesalamine C

Date:12/11/03ISR Number: 4250857-2Report Type:Expedited (15-DaCompany Report #002#1#2003-00508(1) Age:77 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Asthenia Health Colyte-With-Flavor-P

Initial or Prolonged Bladder Distension Professional acks (Flavor

Bronchitis Acute -Unknown)

Constipation (Polyethylene Glycol

Drug Ineffective 3350) PS ORAL 1ONCE, ORAL

Gait Disturbance Lisinopril C

Hypertension Hydrochlorothiazide C

Hyponatraemia Allopurinol C

Lethargy Atenolol C

Oedema Peripheral Furosemide C

Pyrexia

Urinary Retention

Urinary Tract Infection

Venous Insufficiency

18-Apr-2007 11:25 AM Page: 52

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:12/11/03ISR Number: 4251308-4Report Type:Expedited (15-DaCompany Report #200322296GDDC Age:71 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Cerebrovascular Accident Foreign Ramipril (Triatec) PS ORAL 5 MG QD PO

Facial Palsy Other Clobazam (Urbanyl) SS ORAL 10 MG TID PO

Hemiplegia Zopiclone (Imovane) SS ORAL 15 MG/DAY PO

Ischaemic Stroke Furosemide (Lasilix) SS ORAL 40 MG QD PO

Respiratory Distress Propranolol

(Avlocardyl) Tablets SS ORAL 20 MG QD PO

Omeprazole (Mopral)

Capsules SS ORAL 20 MG QD PO

Verapamil

Hydrochloride

(Isoptin - Slow

Release) SS ORAL 240 MG PO

Celecoxib (Celebrex) SS

Simvastatin Tablets SS ORAL 20 MG QD PO

Prednazoline

(Deturgylone) SS QD IN

Paracetamol

(Doliprane) SS ORAL 1000 MG BID

PO

Clonazepam

(Rivotril) SS ORAL 4 MG QD PO

Pipamperone

(Dipiperon) SS ORAL 20 MG QD PO

Trihexyphenidyl

Hydrochloride

(Parkinane) SS ORAL QD PO

Salmeterol Xinafoate

(Serevent Diskus) SS RESPIRATORY

(INHALATION) BID INH

Mianserin

Hydrochloride

(Athymil) SS ORAL 60 MG QD PO

Salbutamol

(Ventoline) SS RESPIRATORY

(INHALATION) INH

Glyceryl Trinitrate

(Trinitrate) SS

Glyceryl Trinitrate

(Discotrine) SS ORAL 10 MG QD PO

Macrogol (Forlax) SS QD

Diacerein (Art 50) SS ORAL 50 MG BID PO

Acetylsalicylate

Lysine (Aspegic)

Powder SS ORAL 250 MG QD PO

Oxygen C

Date:12/23/03ISR Number: 4258396-XReport Type:Expedited (15-DaCompany Report #030037 Age:77 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Blood Sodium Decreased Health Miralax PS ORAL 255 GRAMS PO

Initial or Prolonged Convulsion Professional Synthroid C

Memory Impairment High Cholesterol

Med. C

18-Apr-2007 11:25 AM Page: 53

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:12/23/03ISR Number: 4258401-0Report Type:Expedited (15-DaCompany Report #030038 Age:9 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Accidental Exposure Health Golytely PS INTRAVENOUS 12 CC IV

Initial or Prolonged Urticaria Professional

Date:12/23/03ISR Number: 4258594-5Report Type:Expedited (15-DaCompany Report #002#1#2003-00508(2) Age:77 YR Gender:Male I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Asthenia Health Colyte-With-Flavor-P

Initial or Prolonged Bronchitis Acute Professional acks(Flavor-Unknown)

Constipation (Polyethylene Glycol

Diabetes Mellitus 3350) PS ORAL 1ONCE, ORAL

Non-Insulin-Dependent Lisinopril C

Drug Ineffective Hydrochlorothiazide C

Gait Disturbance Allopurinol C

Hip Arthroplasty Atenolol C

Hypertension Furosemide C

Hyponatraemia

Lethargy

Oedema Peripheral

Pharmaceutical Product

Complaint

Urinary Retention

Urinary Tract Infection

Venous Insufficiency

Date:12/26/03ISR Number: 4259855-6Report Type:Expedited (15-DaCompany Report #K200301888 Age:71 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Cerebral Artery Foreign Altace

Hospitalization - Thrombosis Health Capsules(Ramipril)

Initial or Prolonged Ischaemic Stroke Professional Capsule, 5mg PS ORAL 5 MG, QD,

Nausea Other ORAL

Respiratory Distress Urbanyl (Clobazam)

Respiratory Failure 10mg SS ORAL 10 MG, TID,

ORAL

Imovane (Zopiclone)

15mg SS ORAL 15 MG, QD,

ORAL

Lasilix (Furosemide)

40mg SS ORAL 40 MG, QD,

ORAL

Avlocardyl

(Propranolol)

Tablet, 20mg SS ORAL 20 MG, QD,

ORAL

Mopral (Omeprazole)

Capsule, 20mg SS ORAL 20 MG, QD,

ORAL

Rivotril

(Clonazepam) 4mg SS ORAL 4 MG, QD,

ORAL

Parkinane

(Trihexyphenidyl

Hydrochloride) 1df SS ORAL 1 DF, QD,

ORAL

18-Apr-2007 11:25 AM Page: 54

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Athymil (Mianserin

Hydrochloride) 60mg SS ORAL 60 MG, QD,

ORAL

Aspegic

(Acetylsalicylate

Lysine) Unknown,

250mg SS ORAL 250 MG, QD,

ORAL

Art 50 (Diacerein)

50mg SS ORAL 50 MG, BID,

ORAL

Forlax (Macrogol)

2df SS 2 DF, QD,

Discotrine (Glyceryl

Trinitrate) 10mg SS ORAL 10 MG, QD,

ORAL

Trinitrine (Glyceryl

Trinitrate) SS

Ventoline

(Salbutamol)

Inhalant SS RESPIRATORY

(INHALATION) INHALATION

Serevent Diskus

(Salmeterol

Xinafoate) Inhalant,

1 SS RESPIRATORY

(INHALATION) 1 PUFF, BID,

INHALATION

Dipiperon

(Pipamperone) 20mg SS ORAL 20 MG, QD,

ORAL

Doliprane

(Paracetamol) 1000mg SS ORAL 1000 MG, BID,

ORAL

Isoptin - Slow

Release (Verapamil

Hydrochloride) 240mg SS ORAL 240 MG, QD,

ORAL

Celebrex (Celecoxib) SS

Zocor (Simvastatin)

Tablet, 20mg SS ORAL 20 MG, QD,

ORAL

Deturgylone

(Prednazoline)

Inhalant, 1 C NASAL 1 PUFF, QD,

NASAL

Oxygen (Oxygen) C

Date:12/29/03ISR Number: 4261073-2Report Type:Expedited (15-DaCompany Report #FRWYE475719DEC03 Age: Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Maternal Drugs Affecting Health Effexor Lp

Foetus Professional (Vanlafaxine

Premature Baby Hydrochloride,

Capsule, Extended

Release, 0) PS ORAL 37.5 MG 2X

PER 1 DAY

Forlax (Macrogol, ,

0) SS ORAL 2 TABLET 1X

18-Apr-2007 11:25 AM Page: 55

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

PER 1 DAY

Lysanxia (Prazepam,

, 0) SS ORAL FROM 10 MG TO

30 MG DAILY

Spasfon

(Phlrogoglucinol/Tri

methylphloroglucinol

, , 0) SS ORAL 2 TABLETS

DAILY ON

REQUEST

Date:01/15/04ISR Number: 4274581-5Report Type:Expedited (15-DaCompany Report #863#3#2004-00001 Age:73 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Anaemia Idrolax (Macrogol) PS ORAL 1.10G

Initial or Prolonged Diarrhoea Prednisolone

Neutropenia (Prednisolone) C

Renal Failure Acute Cisplatin

Thrombocytopenia (Cisplatin) C

Fraxiparine

(Heparin-Fraction,

Calcium Salt) C

Alitma C

Jamylene (Dantron,

Docusate Sodium) C

Flecainide

(Flecainide) C

Zopiclone

(Zopiclone) C

Quinapril

(Quinapril) C

Clonazepam

(Clonazepam) C

Domperidone

(Domperidone) C

Date:01/16/04ISR Number: 4275480-5Report Type:Expedited (15-DaCompany Report #040001 Age:59 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Asthenia Health Nulytely PS ORAL 4 LITERS PO

Initial or Prolonged Loss Of Consciousness Professional Norvasc C

Oedema Peripheral Diovan C

Pruritus

Date:01/26/04ISR Number: 4279955-4Report Type:Expedited (15-DaCompany Report #863#3#2004-00002 Age:74 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Cutaneous Vasculitis Foreign Idrolax (Macrogol) PS ORAL 2 SACHETS

Initial or Prolonged Pemphigoid ORAL

Rash Mepronizine

Toxic Skin Eruption (Aceprometazine,

Meprobamate) C

Debridat

(Trimebutine

Maleate) C

Eductyl (Potassium

18-Apr-2007 11:25 AM Page: 56

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Bitartrate, Sodium

Bicarbonate) C

Fragmin

(Heparin-Fraction,

Sodium Salt) C

Valium (epam) C

Hyperium

(Rilmenidine) C

Deroxat (Paroxetine

Hydrochloride) C

Lexomil (Bromazepam) C

Noroxin

(Norfloxacin) C

Date:01/26/04ISR Number: 4279957-8Report Type:Expedited (15-DaCompany Report #863#3#2004-00001 Age:73 YR Gender:Male I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Anaemia Foreign Idrolax (Macrogol) PS ORAL 1.10 G ORAL 17 DAY

Initial or Prolonged Diarrhoea Health Prednisolone

Neutropenia Professional (Prednisolone) C

Renal Failure Acute Other Cisplatin

Thrombocytopenia (Cisplatin) C

Fraxiparine

(Heparin-Fraction,

Calcium Salt) C

Alimita C

Jamylene (Dantron,

Docusate Sodium) C

Flecainide

(Flecainide) C

Zopiclone

(Zopiclone) C

Quinapril

(Quinapril) C

Clonazepam

(Clonazepam) C

Domperidone

(Domperidone) C

Date:01/26/04ISR Number: 4279960-8Report Type:Expedited (15-DaCompany Report #863#1#2003-00018 Age:80 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Depressed Level Of Foreign Idrolax (Macrogol) PS ORAL 1.7 TO 8

Initial or Prolonged Consciousness Health SACHETS AS A

Intentional Overdose Professional SINGLE DOSE

Multiple Drug Overdose Other ORAL 1 DAY

Suicide Attempt Stilnox (Zolpidem) C ORAL

Date:01/27/04ISR Number: 4280571-9Report Type:Expedited (15-DaCompany Report #2004002724 Age:89 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Aggression Foreign Atarax (Tablet)

Initial or Prolonged Chorea Health (Hydroxyzine

Professional Hydrochloride) PS ORAL 25 MG

(DAILY), ORAL

Montelukast Sodium

18-Apr-2007 11:25 AM Page: 57

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

(Montelukast Sodium) SS ORAL ORAL

Lorazepam

(Lorazepam) SS ORAL 4 MG (DAILY),

ORAL

Macrogol (Macrogol) SS ORAL ORAL

Ambroxol

Hydrochloride

(Ambroxol

Hydrochloride) SS ORAL 120 MG

(DAILY), ORAL

Date:02/10/04ISR Number: 4291997-1Report Type:Direct Company Report #CTU 211929 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Diarrhoea Miralax Polyethlene

Pharmaceutical Product Glycol 3350

Complaint Braintree Labs PS Braintree Labs ORAL 1-1 1/2 DAILY

ORAL

Flagyl C

Nystatin C

Lidocaine C

Tetracylclene Mouth

Rinse C

Date:02/11/04ISR Number: 4294054-3Report Type:Expedited (15-DaCompany Report #DSA_23934_2004 Age:89 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Aggression Foreign Temesta PS ORAL 4 MG Q DAY PO

Initial or Prolonged Chorea Health Ambroxol SS ORAL 60 MG BID PO

Professional Atarax SS ORAL 25 MG Q DAY

Other PO

Singulair SS ORAL 1 UNK Q DAY

PO

Transipeg SS ORAL 1 UNK Q DAY

PO

Date:02/11/04ISR Number: 4294269-4Report Type:Periodic Company Report #US-GLAXOSMITHKLINE-A0419714A Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Anticonvulsant Drug Level Lamictal PS Glaxosmithkline ORAL 300MG Three

Below Therapeutic times per day YR

Drug Interaction Crystalloid SS

Miralax SS UNKNOWN

Aciphex C

Glucosamine C

Citrucel C Glaxosmithkline

Calcium C

Colace C

Date:02/23/04ISR Number: 4303935-3Report Type:Periodic Company Report #PHEH2004US01149 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Drug Interaction Consumer Zelnorm (Tegaserod) PS

Flatulence Miralax (Macrogol) SS

18-Apr-2007 11:25 AM Page: 58

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:02/24/04ISR Number: 4304283-8Report Type:Expedited (15-DaCompany Report #04P-163-0250303-00 Age:48 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Dehydration Health Vicodin

Initial or Prolonged Diarrhoea Professional (Hydrocodone/Acetami

Hypotension Other nophen) PS

Nausea Cetuximab SS INTRAVENOUS 250 MG/M2,

Vomiting INTRAVENOUS

Docetaxel SS INTRAVENOUS 56 MG, 1 IN 1

WK,

INTRAVENOUS

Irinotecan SS INTRAVENOUS 80 MG, 1 IN 1

WK,

INTRAVENOUS

Dexamethasone SS ORAL PER ORAL

Heparin-Fraction,

Sodium Salt SS SUBCUTANEOUS 1 IN 1 D,

SUBCUTANEOUS

Macrogol SS

Esomeprazole SS

Lipman C

Fentanyl Citrate C

Loperamide

Hydrochloride C

Tetracycline/Dextrom

ethorphan/Hctz/Nysta

tin C

Chlorpromazine

Hydrochloride C

Date:03/08/04ISR Number: 4314276-2Report Type:Expedited (15-DaCompany Report #2004UW03578 Age:48 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Dehydration Other Nexium PS

Initial or Prolonged Diarrhoea Cetuximab SS INTRAVENOUS 250 MG IV

Hypotension Taxotere SS INTRAVENOUS 56 MG IV

Nausea Irinotecan SS INTRAVENOUS 80 MG IV

Vomiting Lovenox SS 1/1 DAY

Desametasone SS

Miralax SS

Vicodin SS

Lipram SS

Duragesic C

Imodium "Janssen" C

Thorazine C

Date:03/12/04ISR Number: 4316848-8Report Type:Direct Company Report #USP 56376 Age: Gender: I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Medication Error Miralax (Peg 3350 ,

Nf Powder For

Solution) PS Braintree Labs POWER

18-Apr-2007 11:25 AM Page: 59

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:04/01/04ISR Number: 4330197-3Report Type:Expedited (15-DaCompany Report #2004007196 Age:20 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Abnormal Sensation In Eye Health Visine Moisturizing

Eye Irritation Professional (Polyethylene

Medication Error Glycol,

Ocular Hyperaemia Tetrahydrozoline

Superficial Injury Of Eye Hydrochloride) PS OPHTHALMIC OHPTHALMIC

Date:04/12/04ISR Number: 4339365-8Report Type:Expedited (15-DaCompany Report #040012 Age:68 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Swelling Face Health Cherry Nulytely PS ORAL 4 LITERS PO

Swollen Tongue Professional Lipitor C

Throat Tightness Baby Aspirin C

Date:04/15/04ISR Number: 4341635-4Report Type:Expedited (15-DaCompany Report #040014 Age:12 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Aphthous Stomatitis Consumer Miralax PS ORAL 8.5 GRAMS

ONCE DAY PO 3 WK

Date:04/15/04ISR Number: 4341641-XReport Type:Expedited (15-DaCompany Report #040013 Age:52 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Ileus Other Golytely PS 4 LITERS NG

Intestinal Obstruction Oxybutin C

Megacolon

Date:04/19/04ISR Number: 4343786-7Report Type:Expedited (15-DaCompany Report #040015 Age:81 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Eye Swelling Consumer Miralax PS ORAL 17 GRAMS 1X

Flank Pain DAY PO

Myalgia Betaxolol C

Oedema Peripheral Zantac C

Pain In Extremity Evista C

Lipitor C

Adult Aspirin C

Meclizine C

Levothyroxine C

Ambien C

Date:04/19/04ISR Number: 4343791-0Report Type:Expedited (15-DaCompany Report #040016 Age:39 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Hypersensitivity Consumer Miralax PS ORAL 17 GRAMS EOD

Temporal Arteritis PO 3 WK

Loestrin C

18-Apr-2007 11:25 AM Page: 60

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:04/21/04ISR Number: 4343236-0Report Type:Expedited (15-DaCompany Report #GB-MERCK-0404GBR00108 Age:3 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Hepatomegaly Decadron Tablets PS Merck & Co., Inc ORAL

Hypertriglyceridaemia Asparaginase (As

Drug) And

Polyethylene Glycol SS UNKNOWN 1 DAY

Decadron Tablets SS Merck & Co., Inc ORAL

Asparaginase (As

Drug) And

Polyethylene Glycol SS UNKNOWN 1 DAY

Enoxaparin Sodium C UNKNOWN

Sulfamethoxazole And

Trimethoprim C UNKNOWN 2 DAY

Sulfamethoxazole And

Trimethoprim C UNKNOWN 2 DAY

Sulfamethoxazole And

Trimethoprim C UNKNOWN 2 DAY

Sulfamethoxazole And

Trimethoprim C UNKNOWN 2 DAY

Vincristine Sulfate C UNKNOWN 15 DAY

Date:04/26/04ISR Number: 4347232-9Report Type:Expedited (15-DaCompany Report #GB-MERCK-0404GBR00108 Age:3 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Hepatomegaly Decadron Tablets PS Merck & Co., Inc ORAL

Initial or Prolonged Hypertriglyceridaemia Asparaginase (As

Other Drug) And

Polyethylene Glycol SS INTRAMUSCULAR 1 DAY

Decadron Tablets SS Merck & Co., Inc ORAL

Asparaginase (As

Drug) And

Polyethylene Glycol SS UNKNOWN 1 DAY

Enoxaparin Sodium C UNKNOWN

Sulfamethoxazole And

Trimethoprim C UNKNOWN 2 DAY

Sulfamethoxazole And

Trimethoprim C UNKNOWN 2 DAY

Sulfamethoxazole And

Trimethoprim C UNKNOWN 2 DAY

Sulfamethoxazole And

Trimethoprim C UNKNOWN 2 DAY

Vincristine Sulfate C INTRAVENOUS 15 DAY

Date:04/28/04ISR Number: 4349969-4Report Type:Direct Company Report #CTU 217631 Age: Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Hypotension Golytely 4 Liters

Initial or Prolonged ?-? Drank Only A

Small Portion PS FLEETS

PHOSPHO SODA

Bisacodyl 10 Mg , 20

Mg SS FLEETS OIL

RETENTION

EMEMA

Acetaminophen C

Acetainophen/Oxycodo

18-Apr-2007 11:25 AM Page: 61

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

ne C

Brimonidine Tartrate C

Dorzolamide

2%/Timolol C

Levothyroxine Na

(Synthoid) C

Morphine Sulfate C

Ranitidine Hcl C

Sodium Chloride C

Temazepam C

Date:05/03/04ISR Number: 4354712-9Report Type:Expedited (15-DaCompany Report #040012 Age:68 YR Gender:Male I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Hypersensitivity Health Cherry Nulytely PS ORAL 4 LITERS PO

Swelling Face Professional Lipitor C

Swollen Tongue Baby Aspirin C

Throat Tightness

Date:05/10/04ISR Number: 4356426-8Report Type:Direct Company Report #CTU 218287 Age:75 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Asthenia Colyte (Generic) PS 1 GALLON

Initial or Prolonged Blood Sodium Decreased

Pharmaceutical Product

Complaint

Date:05/12/04ISR Number: 4359315-8Report Type:Expedited (15-DaCompany Report #040019 Age:9.5 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Arrhythmia Consumer Miralax PS ORAL 8.5 GRAMS

Headache DAILY PO

Muscle Spasms Antibiotics (Strep

Tic Throat & Ear

Vision Blurred Infection) C

Date:05/14/04ISR Number: 4360464-9Report Type:Expedited (15-DaCompany Report #002#1#2004-00105 Age:75 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Life-Threatening Abasia Health Peg-3350- & -Electroly

Hospitalization - Asthenia Professional ts-For-Oral-Solution

Initial or Prolonged Confusional State (Polyethylene Glycol

Hyponatraemia 3350) PS ORAL 1ONCE, ORAL

Pharmaceutical Product Nefazodone C

Complaint Zolpidem-Tartrate C

Digestive-Enzymes C

Date:05/19/04ISR Number: 4361367-6Report Type:Direct Company Report #CTU 218927 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Eye Pain Systane Lubricant

Eye Drops Alcon

18-Apr-2007 11:25 AM Page: 62

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Laboratory PS Alcon Laboratory

Date:06/08/04ISR Number: 4376403-0Report Type:Expedited (15-DaCompany Report #002#1#2004-00105 Age:75 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Life-Threatening Abasia Health Peg-3350- & -Electroly

Hospitalization - Asthenia Professional tes-For-Oral-Solutio

Initial or Prolonged Confusional State Company n (Polyethylene

Hyponatraemia Representative Glycol 3350) PS ORAL 1ONCE, ORAL

Pharmaceutical Product Other Nefazodone C

Complaint Zolpidem-Tartrate C

Digestive-Enzymes C

Date:07/02/04ISR Number: 4392309-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040403585 Age:76 YR Gender:Male I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Dermatitis Consumer Duragesic (Fentanyl)

Feeling Abnormal Health Patch PS TRANSDERMAL 200 UG/HR, 1

Nausea Professional IN 48 HOUR,

Neuropathy Peripheral TRANSDERMAL

Pain In Extremity Miralax (Macrogol) SS

Prostate Cancer Senokot (Senna

Fruit) C

Date:07/12/04ISR Number: 4399338-6Report Type:Expedited (15-DaCompany Report #040034 Age:53 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Dizziness Health Nulytely PS ORAL 4 LITERS PO

Hypokalaemia Professional

Hyponatraemia

Date:07/23/04ISR Number: 4407244-3Report Type:Direct Company Report #CTU 223450 Age:53 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Asthenia Nulytely For Oral

Initial or Prolonged Confusional State Solution Dist By

Dizziness Braintree Labs PS Braintree Labs 8 OZ EVERY 10

Electrolyte Imbalance MINUTES

Hypokalaemia

Hyponatraemia

Paraesthesia

Date:07/27/04ISR Number: 4412918-4Report Type:Expedited (15-DaCompany Report #040041 Age:39 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Diarrhoea Consumer Miralax PS ORAL 17 GRAMS

Drug Exposure Via Breast DAILY PO

Milk

18-Apr-2007 11:25 AM Page: 63

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:08/20/04ISR Number: 4432552-XReport Type:Expedited (15-DaCompany Report #040041 Age:39 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Diarrhoea Consumer Miralax PS ORAL 17 GRAMS

Drug Exposure Via Breast DAILY PO

Milk

Date:08/25/04ISR Number: 4433991-3Report Type:Expedited (15-DaCompany Report #2004056325 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Disability Complex Regional Pain Consumer Neurontin

Other Syndrome (Gabapentin) PS 900 MG (300

Nerve Injury MG, 3 IN 1 D)

Upper Limb Fracture Morphine Sulfate

(Morphine Sulfate) SS 30 MG (30 MG,

1 IN 1 D)

Macrogol (Macrogol) SS (2 IN 1 D)

All Other

Therapeutic

Products) SS (3 IN 1 D)

Thyroid Hormones

(Thyroid Hormones) SS (1 IN 1 D)

Date:08/30/04ISR Number: 4439798-5Report Type:Expedited (15-DaCompany Report #863#3#2004-00004 Age:85 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Drug Ineffective Foreign Idrolax (Macrogol) PS ORAL 1.10 G ORAL

Initial or Prolonged Fluindione

(Fluindione) SS ORAL UP TO 1.75

TABLET ORAL

Paracetamol

(Paracetamol) SS

Omeprazole

(Omeprazole) SS ORAL 20 MG ORAL

Date:09/02/04ISR Number: 4457413-1Report Type:Periodic Company Report #002#2#2004-00149 Age:45 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Anaphylactoid Reaction Consumer Trilyte-With-Flavor-

Required Packs (Polyethylene

Intervention to Glycol 3350) PS ORAL 8OU, 1 OUNCE,

Prevent Permanent ORAL

Impairment/Damage Hormone-Replacement-

Therapy C

Esomeprazole C

Celecoxib C

Date:09/03/04ISR Number: 4445300-4Report Type:Expedited (15-DaCompany Report #DSA_24862_2004 Age:42 YR Gender:Male I/FU:I

Outcome PT Report Source

Death Completed Suicide Foreign

Multiple Drug Overdose Health

Professional

18-Apr-2007 11:25 AM Page: 64

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Other

Product Role Manufacturer Route Dose Duration

Ativan PS

Clozapine SS

Movicol SS

Zoplicone SS

Date:09/07/04ISR Number: 4445929-3Report Type:Direct Company Report #CTU 226512 Age:4 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Constipation Glycolax PS ORAL 1/2 CAPFUL

Faecal Volume Decreased 8.5 GR IN 4

Faeces Hard OZ FLUID PO

DAILY

Date:09/09/04ISR Number: 4448715-3Report Type:Expedited (15-DaCompany Report #863#3#2004-00004 Age:85 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Drug Ineffective Idrolax (Macrogol) PS ORAL 10 G

Initial or Prolonged Drug Interaction Fluindione

Inhibition (Fluindione) SS ORAL UP TO 1.7 5

TABLET

Paracetamol

(Paracetamol) SS

Omeprazole

(Omeprazole) SS ORAL 20 MG

Date:09/10/04ISR Number: 4446041-XReport Type:Expedited (15-DaCompany Report #FR-GLAXOSMITHKLINE-B0343968A Age:85 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Dermatitis Bullous Consumer Deroxat PS Glaxosmithkline ORAL 20MG Per day

Initial or Prolonged Pruritus Risperdal SS ORAL 1MG Per day 19 MON

Densical SS Glaxosmithkline ORAL 1UNIT Per day

Transipeg SS ORAL 2UNIT per day

Tiapridal C ORAL 5DROP per day

Date:09/10/04ISR Number: 4448388-XReport Type:Direct Company Report #CTU 226846 Age:70 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Drug Ineffective Miralax 17 Gm W/ 8

Flatulence Oz H2o PS

Pharmaceutical Product

Complaint

Date:09/13/04ISR Number: 4449489-2Report Type:Expedited (15-DaCompany Report #863#1#2004-00005 Age:97 YR Gender:Male I/FU:I

Outcome PT

Other Abdominal Pain

Condition Aggravated

Constipation

18-Apr-2007 11:25 AM Page: 65

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Flatulence

Fluid Intake Reduced

Heat Exposure Injury Report Source Product Role Manufacturer Route Dose Duration

Subileus Health Idrolax (Macrogol) PS ORAL (10G 1 IN 1

Professional DAY(S)), ORAL

Sinemet (Carbidopa,

Levodopa) C

Losartan (Losartan

Potassium) C

Bicalutamide

(Bicalutamide) C

Iron (Iron) C

Date:09/14/04ISR Number: 4450557-XReport Type:Expedited (15-DaCompany Report #040044 Age:54 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Anorexia Other Miralax PS ORAL 2 DOSES PO

Hospitalization - Asthenia Vicodin C

Initial or Prolonged Balance Disorder Digoxin C

Confusional State Simvastatin C

Dehydration Carvedilol C

Diarrhoea Fentanyl C

Disease Progression Dexamethasone C

Dry Mouth Topotecan (Study

Hypotension Med) C

Infection Taxotere (Study Med) C

Medication Error

Date:09/15/04ISR Number: 4451840-4Report Type:Direct Company Report #CTU 227108 Age:78 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Drug Effect Decreased Glycolax 3350 None

Pharmaceutical Product Kremers Urban PS Kremers Urban ORAL 1 TBS PER DAY

Complaint ORAL

Date:09/17/04ISR Number: 4454412-0Report Type:Direct Company Report #CTU 227478 Age:17 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Constipation Miralax PS

Pharmaceutical Product

Complaint

Date:09/20/04ISR Number: 4454022-5Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12698320 Age:42 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Cardiac Disorder Carbidopa + Levodopa PS Bristol-Myers Squibb

Other Overdose Company

Clozapine SS ORAL

Movicol SS "3350/kcl/nah

co3/nacl"

Lorazepam SS

Zoplicone SS

Citalopram SS

18-Apr-2007 11:25 AM Page: 66

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:09/21/04ISR Number: 4456747-4Report Type:Expedited (15-DaCompany Report #2004CG01814 Age:82 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Rectal Haemorrhage Foreign Tenormine PS

Initial or Prolonged Health Aspegic /Fra/ SS 100 MG QD

Professional Fludex SS 1 DF QD

Other Tahor SS

Corvasal SS

Triatec SS 20 MG QD

Zyloric "Glaxo

Wellcome" SS

Chibro-Proscar SS

Forlax SS

Maxepa SS

Date:09/22/04ISR Number: 4457515-XReport Type:Expedited (15-DaCompany Report #002#1#2004-00214 Age:50 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Abasia Consumer Peg-3350- & -Electroly

Initial or Prolonged Abdominal Distension Health tes-For-Oral-Solutio

Disability Blood Magnesium Decreased Professional n (Polyethylene

Blood Potassium Decreased Glycol 3350) PS ORAL 41, 1ONCE,

Fatigue ORAL

Fibromyalgia

Insomnia

Myocardial Infarction

Nerve Injury

Oedema Peripheral

Rhabdomyolysis

Date:09/28/04ISR Number: 4463471-0Report Type:Expedited (15-DaCompany Report #DSA_24862_2004 Age:42 YR Gender:Male I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Cardiac Disorder Foreign Ativan PS

Intentional Overdose Health Citalopram SS

Suicide Attempt Professional Clopazine SS

Other Movicol SS

Sinemet SS

Zoplicone SS

Ativan SS ORAL 1 MG Q DAY PO

Citalopram SS 40 MG

Clozapine SS

Movicol SS

Sinemet SS

Zoplicone SS

Date:09/29/04ISR Number: 4462263-6Report Type:Expedited (15-DaCompany Report #FR-GLAXOSMITHKLINE-B0343968A Age:85 YR Gender:Male I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Antinuclear Antibody Deroxat PS Glaxosmithkline ORAL 20MG Per day

Initial or Prolonged Positive Risperdal SS ORAL 1MG Per day 19 MON

Dermatitis Bullous Densical SS Glaxosmithkline ORAL 1UNIT Per day

Immunology Test Abnormal Transipeg SS ORAL 2UNIT per day

Pruritus Tiapridal C ORAL 5DROP per day

Toxic Skin Eruption

18-Apr-2007 11:25 AM Page: 67

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:09/29/04ISR Number: 4463720-9Report Type:Expedited (15-DaCompany Report #2004CG01890 Age:92 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Hyperkalaemia Foreign Mopral PS ORAL 20 MG QD PO

Initial or Prolonged Hyponatraemia Health Coversyl SS ORAL 2 MG QD PO

Professional Transipeg SS ORAL 2.95 GR BID

Other PO

Ikorel SS ORAL 20 MG BID PO

Lodales SS ORAL 20 MG QD PO

Imovane C

Mixtard "Novo

Nordisk" C

Date:10/01/04ISR Number: 4464337-2Report Type:Expedited (15-DaCompany Report #FR-MERCK-0409USA01949 Age:92 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Hyperkalaemia Zocor PS Merck & Co., Inc ORAL

Initial or Prolonged Hyponatraemia Ikorel SS ORAL

Mopral (Omeprazole) SS ORAL

Coversyl SS ORAL

Transipeg SS ORAL

Mixtard C SUBCUTANEOUS

Imovane C ORAL

Mixtard C SUBCUTANEOUS

Date:10/02/04ISR Number: 4472852-0Report Type:Direct Company Report #CTU 229395 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Life-Threatening Hypersensitivity Trilyte With Flavor

Hospitalization - Medication Error Packs PS Schwarz Pharma ORAL 64 OZ ONE

Initial or Prolonged Pharmaceutical Product TIME ORAL

Complaint

Date:10/13/04ISR Number: 4473936-3Report Type:Expedited (15-DaCompany Report #2004071923 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Cataract Consumer Visine Tears

Preservative Free

(Glycerin,

Hydroxypropylmethylc

ellulose, PS OPHTHALMIC A SINGLE USE

EVERY HOUR,

OPTHALMIC

Digoxin (Digoxin) C

Levothyroxine Sodium

(Levothyroxine

Sodium) C

Cyanocobalamin

(Cyanocobalamin) C

18-Apr-2007 11:25 AM Page: 68

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:10/20/04ISR Number: 4479339-XReport Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040900514 Age:85 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Dermatitis Bullous Health Risperdal PS OROPHARINGEAL

Initial or Prolonged Pemphigoid Professional Calcium Carbonate SS OROPHARINGEAL

Pruritus Deroxat SS

Skin Ulcer Transipeg SS OROPHARINGEAL 2 sachets per

Toxic Skin Eruption day

Date:10/21/04ISR Number: 4484035-9Report Type:Expedited (15-DaCompany Report #002#2#2004-00241 Age:58 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Abdominal Distension Consumer Glycolax

Required Abdominal Pain (Polyethylene Glycol

Intervention to Faeces Discoloured 3350) PS ORAL 17G, 1 IN 1

Prevent Permanent Melaena D, ORAL

Impairment/Damage Tongue Discolouration Celecoxib C

Vomiting Hydroxychloroquine C

Prednisone C

Leflunomide C

Fentanyl C

Acetylsalicylic-Acid C

Omeprazole C

Clonazepam C

Venlafaxine-Hydrochl

oride C

Rosuvastatin-Calcium C

Levothyroxine C

Nitroglycerin C

Famotidine C

Amoxicillin C

Omega-3-Fatty-Acids C

Multivitamin C

Date:11/03/04ISR Number: 4493960-4Report Type:Direct Company Report #CTU 231106 Age: Gender: I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Drug Ineffective Glycolax PS 17 A/4 MG @HS

Date:11/08/04ISR Number: 4496206-6Report Type:Direct Company Report #CTU 231423 Age: Gender: I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Change Of Bowel Habit Glycolax PS 17 A 4MG CHS

Drug Ineffective

Date:11/09/04ISR Number: 4498051-4Report Type:Direct Company Report #CTU 231554 Age:9 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Anger Miralax PS ORAL 17G DAY

Anxiety ORAL

18-Apr-2007 11:25 AM Page: 69

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:11/12/04ISR Number: 4500526-6Report Type:Direct Company Report #CTU 231830 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Dyspepsia Glycolax PS 17 GM

Pharmaceutical Product

Complaint

Date:11/15/04ISR Number: 4501654-1Report Type:Direct Company Report #CTU 231891 Age:6 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Drug Ineffective Glyco-Lax PS 17 GRAMS WITH

Pharmaceutical Product 8 OZ H2O Q

Complaint DAY

Date:11/15/04ISR Number: 4504039-7Report Type:Expedited (15-DaCompany Report #2004070094 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Cataract Operation Consumer Visine Tears

Dry Skin (Glycerin,

Eye Pruritus Hydroxypropylmethylc

ellulose,

Polyethylene Glycol) PS OPHTHALMIC 1-2 DROPS

2-3X DAILY,

OPHTHALMIC

Prednisone

(Prednisone0 C

Valsartan

(Valsartan) C

Date:11/15/04ISR Number: 4504151-2Report Type:Expedited (15-DaCompany Report #040051 Age:65 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Blood Electrolytes Consumer Halflytely And

Initial or Prolonged Abnormal Bisacodyl Tablets

Dehydration Bowel Prep Kit PS ORAL 4 BIS/1X/PO

Diarrhoea High Blood Pressure C

Vomiting Calcium Supplement C

Multivitamin C

Date:11/16/04ISR Number: 4505194-5Report Type:Expedited (15-DaCompany Report #2004079052 Age:79 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Burning Sensation Consumer Visine Tears

Eye Irritation (Glycerin,

Hydroxypropylmethylc

elluose, Polythylene

Glycol) PS OPHTHALMIC SEE IMAGE

Visine Tears

(Glycerin,

Hydroxypropylmethylc

ellulose,

Polyethylene, SS

18-Apr-2007 11:25 AM Page: 70

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:11/17/04ISR Number: 4678451-XReport Type:Direct Company Report #CTU 241180 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Condition Aggravated Generic Miralax PS ORAL ORAL 1-2 X QD

Constipation

Drug Ineffective

Therapeutic Response

Unexpected With Drug

Substitution

Date:11/18/04ISR Number: 4504325-0Report Type:Expedited (15-DaCompany Report #200414279FR Age:69 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Condition Aggravated Lovenox PS Aventis

Initial or Prolonged Pharmaceuticals Inc. SUBCUTANEOUS

Primperan SS ORAL

Skenan SS ORAL

Effexor SS ORAL

Tracleer SS ORAL

Omeprazole SS ORAL

Movicol SS

Date:11/22/04ISR Number: 4678664-7Report Type:Direct Company Report #CTU 239851 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Constipation Glycolax (Generic

Miralax) PS

Date:11/24/04ISR Number: 4512370-4Report Type:Expedited (15-DaCompany Report #002#2#2004-00241 Age:58 YR Gender:Male I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Abdominal Distension Consumer Glycolax

Required Abdominal Pain (Polyethylene Glycol

Intervention to Gallbladder Disorder 3350) PS ORAL 17 G, 1 IN 1

Prevent Permanent Melaena D, ORAL

Impairment/Damage Tongue Discolouration Glycolax

Vomiting (Polyethylene Glycol

3350) SS ORAL 17 G, 1 IN 1

D, ORAL

Celecoxib C

Hydroxychloroquine C

Prednisone C

Leflunomide C

Fentanyl C

Acetylsalicylic Acid C

Omeprazole C

Clonazepam C

Venlafaxine-Hydrochl

oride C

Rosuvastatin-Calcium C

Levothyroxine C

Nitroglycerin C

Famotidine C

Amoxicillin C

Omega-3-Fatty-Acids C

18-Apr-2007 11:25 AM Page: 71

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Multivitamin C

Date:11/26/04ISR Number: 4515434-4Report Type:Expedited (15-DaCompany Report #040051 Age:65 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Blood Electrolytes Consumer Halflytely And

Initial or Prolonged Abnormal Bisacodyl Tablets

Blood Potassium Decreased Bowel Prep Kit PS ORAL 4 BIS/1X/PO

Dehydration High Blood Pressure

Diarrhoea Medication C

Vomiting Calcium Supplements C

Multivitamin C

Date:11/29/04ISR Number: 4514801-2Report Type:Direct Company Report #CTU 233066 Age:76 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Drug Ineffective Glycolax PS QD THEN BID

Date:11/29/04ISR Number: 4527767-6Report Type:Periodic Company Report #040051 Age:65 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Diarrhoea Consumer Halflytely And

Initial or Prolonged Vomiting Bisacodyl Tablets

Bowel Prep Kit PS ORAL 4 BIS/1X/PO

High Blood Pressure

Medication C

Calcium Supplements C

Multivitamin C

Date:12/01/04ISR Number: 4514944-3Report Type:Expedited (15-DaCompany Report #200414279FR Age:69 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Condition Aggravated Lovenox PS Aventis

Initial or Prolonged Pulmonary Hypertension Pharmaceuticals Inc. SUBCUTANEOUS

Primperan SS ORAL

Skenan SS ORAL

Effexor SS ORAL

Tracleer SS ORAL

Omeprazole SS ORAL

Movicol SS

Date:12/02/04ISR Number: 4518452-5Report Type:Expedited (15-DaCompany Report #2004089226 Age:67 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Drug Effect Decreased Consumer Visine

Lens Implant (Oxymetazoline) PS OPHTHALMIC OPHTHALMIC

Visine Tears

(Glycerin,

Polyethylene Glycol,

Hydroxypropylmethyl

cellulose) SS OPHTHALMIC 1-2 TIMES

18-Apr-2007 11:25 AM Page: 72

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

DAILY,

OPHTHALMIC

Date:12/03/04ISR Number: 4519590-3Report Type:Expedited (15-DaCompany Report #M2004-1803 Age:42 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Cardiac Disorder Foreign Caridopa/Levodopa PS

Multiple Drug Overdose Other Lorazepam SS 1MG

Denzapine

(Clozapine) SS ORAL ORAL

Movicol (Potassium

Chloride/Macrogol/So

dium

Bicarbonate/Sodium

Chloride) SS 2 SACHETS

Zopiclone

(Zopiclone) SS 3.75 MG

Citalopram

(Citalopram) SS 40 MG

Date:12/06/04ISR Number: 4521685-5Report Type:Expedited (15-DaCompany Report #L04-USA-07403-02 Age:53 YR Gender: I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Completed Suicide Literature Levothyroxine PS

Multiple Drug Overdose Health Ethylene Glycol

Professional (Polyethylene

Glycol) SS

Gabapentin SS

Date:12/08/04ISR Number: 4521628-4Report Type:Direct Company Report #CTU 233889 Age: Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Disturbance In Attention Miralax Peg3350

Irritability Braintree PS ORAL 17 GRAMS

Mood Swings PER DAY

Pollakiuria ORAL

Psychomotor Hyperactivity

Tic

Date:12/10/04ISR Number: 4523683-4Report Type:Expedited (15-DaCompany Report #FR-GLAXOSMITHKLINE-B0293314A Age:45 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Anaemia Trizivir PS Glaxosmithkline ORAL 1TAB Twice

Initial or Prolonged Coagulation Factor V per day 40 DAY

Level Decreased Diffu K SS Glaxosmithkline ORAL 55 DAY

Hepatocellular Damage Mopral SS Glaxosmithkline ORAL 20MG per day 82 DAY

Prothrombin Level Stilnox SS ORAL 1TAB per day 52 DAY

Decreased Forlax SS ORAL 3SAC per day 53 DAY

Prothrombin Time

Shortened

18-Apr-2007 11:25 AM Page: 73

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:12/15/04ISR Number: 4529326-8Report Type:Direct Company Report #CTU 234328 Age:40 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Abdominal Pain Leader Allergy (Otc) PS Leader 1/DAY 3 DAYS 3 DAY

Arrhythmia Nu Lytely SS AS LABELED

Bedridden

Blood Bilirubin Increased

Blood Test Abnormal

Dehydration

Dysgeusia

Fatigue

Heart Rate Decreased

Lipase Increased

Date:12/16/04ISR Number: 4530534-0Report Type:Expedited (15-DaCompany Report #A02200403558 Age:45 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Anaemia Macrocytic Foreign Stilnox - (Zolpidem)

Initial or Prolonged Eosinophil Count Health - Tablet - 10 Mg PS ORAL 10 MG OD ORAL 52 DAY

Increased Professional Diffu K - (Potassium

Neutrophil Percentage Chloride) - Capsule

Decreased - 600 Mg SS ORAL ORAL 7 WK

White Blood Cell Count Mopral -

Decreased (Omeprazole) -

Capsule - 20 Mg SS ORAL 20 MG OD ORAL 82 DAY

Forlax - (Macrogol)

- Powder - 10 G SS ORAL 30 G QD ORAL 53 DAY

Trizivir -

(Abacavir,

Zidovudine,

Lamivudine) - Tablet SS ORAL 1 DF BID ORAL 40 DAY

Date:12/21/04ISR Number: 4534019-7Report Type:Direct Company Report #CTU 234768 Age:89 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Dyspepsia Polyethylene Glycol

Pharmaceutical Product 3350 Pwd 527g; PS MIX AND TAKE

Complaint 1

TABLESPOONFUL

IN 8 OUNCES

OF WATER

Date:12/21/04ISR Number: 4538129-XReport Type:Expedited (15-DaCompany Report #2004013642 Age:58 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Acute Generalised Foreign Atarax (Tablet)

Initial or Prolonged Exanthematous Pustulosis Health (Hydroxyzine

Chills Professional Hydrochloride) PS ORAL 100 MG, ORAL

Pyrexia Zyrtec (Tablets)

Skin Test Positive (Cetirizine) SS

Atropine Sulfate

(Atropine Sulfate)

(Atropine Sulfate) SS INTRAVENOUS 0.5 MG,

INTRAVENOUS

Colopeg (Sodium

18-Apr-2007 11:25 AM Page: 74

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Bicarbonate,

Potassium Chloride,

Sodium Chloride,

Sodium Sulfate, SS ORAL ORAL

Omeprazole

(Omeprazole) SS ORAL 20 MG, ORAL

Propofol (Propofol) SS INTRAVENOUS INTRAVENOUS

Paracetamol

(Paracetamol) C

Simvastatin

(Simvastatin) C

Bromazepam

(Bromazepam) C

Calcipotriol

(Calcipotriol) C

Date:12/23/04ISR Number: 4536857-3Report Type:Expedited (15-DaCompany Report #FR-GLAXOSMITHKLINE-B0293314A Age:45 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Anaemia Trizivir PS Glaxosmithkline ORAL 1TAB Twice

Initial or Prolonged Anti-Hbc Antibody per day 40 DAY

Positive Diffu K SS Glaxosmithkline ORAL 55 DAY

Anti-Hbs Antibody Mopral SS Glaxosmithkline ORAL 20MG per day 82 DAY

Positive Stilnox SS ORAL 1TAB per day 52 DAY

Aspartate Forlax SS ORAL 3SAC per day 53 DAY

Aminotransferase Rivotril SS ORAL 11 DAY

Increased Skenan SS Glaxosmithkline ORAL 70MG per day 39 DAY

Coagulation Factor V Introna SS SUBCUTANEOUS 11 DAY

Level Decreased

Disseminated

Intravascular Coagulation

Fibrinolysis

Hepatic Steatosis

Hepatocellular Damage

Prothrombin Level

Decreased

Date:12/23/04ISR Number: 4539951-6Report Type:Expedited (15-DaCompany Report #2004013642 Age:58 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Acute Generalised Foreign Atarax (Tablet)

Initial or Prolonged Exanthematous Pustulosis Health (Hydroxyzine

Chills Professional Hydrochloride) PS ORAL 100 MG, ORAL

Pyrexia Zyrtec (Tablets)

Skin Test Positive (Cetirizine) SS

Atropine Sulfate

(Atropine Sulfate)

(Atropine Sulfate) SS INTRAVENOUS 05 MG,

INTRAVENOUS

Colopeg (Sodium

Bicarbonate,

Potassium Chloride,

Sodium Chloride,

Sodium Sulfate, SS ORAL ORAL

Omeprazole

(Omeprazole) SS ORAL 20 MG, ORAL

Propofol ((Propofol) SS INTRAVENOUS INTRAVENOUS

Paracetamol

18-Apr-2007 11:25 AM Page: 75

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

(Paracetamol) C

Simvastatin

(Simvastatin) C

Bromazepam

(Bromazepam) C

Calcipotriol

(Calcipotriol) C

Date:12/29/04ISR Number: 4542317-6Report Type:Expedited (15-DaCompany Report #2004110505 Age:79 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Cataract Consumer Visine Tears

(Glycerin,

Polyethylene Glycol,

Hydroxypropylmethylc

ellulose) PS OPHTHALMIC 1 DROP EACH

EYE QD-BID

PRN,

OPHTHALMIC

Calcium With Vitamin

D (Calcium

Phosphate, Calcium

Sodium Lactate,

Erogocalciferol) SS

Simvastatin

(Simvastatin) C

Tocopherol

(Tocopherol) C

Ascorbic Acid

(Ascorbic Acid) C

Tocopherol/Vitamins

Nos (Tocopherol,

Vitamins Nos) C

Methylcellulose

(Methylcellulose) C

Date:12/29/04ISR Number: 4542968-9Report Type:Expedited (15-DaCompany Report #A02200403558 Age:45 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Anaemia Macrocytic Foreign Stilnox

Initial or Prolonged Eosinophil Count Health (Zolpidem) PS ORAL 10 MG QD

Increased Professional Diffu K (Potassium

Neutrophil Percentage Other Chloride)-Capsule-60

Decreased 0 Mg SS ORAL

Mopral (Omeprazole)

Capsule 20 Mg SS ORAL 20 MG QD

Forlax (Macrogol )

Powder10 G SS ORAL 30 G QD

Trizivir

(Abacabvir,

Zidovudine,

Lamivudine) SS ORAL 1 DF BID

18-Apr-2007 11:25 AM Page: 76

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:01/05/05ISR Number: 4548243-0Report Type:Direct Company Report #CTU 235765 Age:74 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Abdominal Pain Halflytely PS SINGLE DOSE

Colitis Ischaemic (2L)

Rectal Haemorrhage Thyroid C

Vomiting Zyrtec C

Asa C

Date:01/06/05ISR Number: 4549625-3Report Type:Expedited (15-DaCompany Report #040067 Age:66 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Colitis Consumer Halflytely And

Initial or Prolonged Colon Cancer Bisacodyl Tablets

Large Intestinal Ulcer Bowel Prep Kit PS 20 MG/2 LITER

Amitriptyline C

Estradiol C

Advil C

Date:01/06/05ISR Number: 4549639-3Report Type:Expedited (15-DaCompany Report #040069 Age:68 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Abdominal Pain Health Halflytely And

Haemorrhage Professional Bisacodyl Tablets

Intestinal Ischaemia Bowel Prep Kit PS 20 MG/2 LITER

Date:01/06/05ISR Number: 4549652-6Report Type:Expedited (15-DaCompany Report #040068 Age:75 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Anaemia Health Halflytely And

Colitis Ischaemic Professional Bisacodyl Tablets

Weight Decreased Bowel Prep Kit PS 20 MG/2 LITER

Date:01/10/05ISR Number: 4585481-5Report Type:Direct Company Report #USP 57068 Age: Gender: I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Medication Error Miralax PS Braintree POWDER FOR

RECONSTITUTIO

N

Maalox SS Novartis LIQUID

Date:01/10/05ISR Number: 4878944-6Report Type:Direct Company Report #CTU 266570 Age:3 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Drug Hypersensitivity Glycolax 17 G

Kremers Urban PS Kremers Urban TWICE DAILY

18-Apr-2007 11:25 AM Page: 77

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:01/11/05ISR Number: 4550024-9Report Type:Direct Company Report #CTU 236171 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Drug Effect Decreased Generic Mirolax

Pharmaceutical Product Powder PS 17 GM BID UP

Complaint TO QID PRN

(1-4 CAPS)

Date:01/11/05ISR Number: 4550541-1Report Type:Direct Company Report #CTU 236163 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Drug Ineffective Glycolax PS 1 CAP / DAY

Pharmaceutical Product

Complaint

Date:01/11/05ISR Number: 4551834-4Report Type:Expedited (15-DaCompany Report #2004AL002094 Age:45 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Anaemia Foreign Kadian

Initial or Prolonged Anti-Hbc Antibody Health (Morphine Sulfate

Positive Professional Sustained Release) PS Alpharma ORAL 70 MG; QD; PO

Anti-Hbs Antibody Other Trizivir SS ORAL BID; PO

Positive Potassium Chloride SS ORAL PO

Coagulation Factor V Omeprazole SS ORAL 20 MG, QD, PO

Level Decreased Zolpidem SS ORAL QD; PO

Coagulation Factor Vii Macrogol 4000 SS ORAL QD; PO

Level Decreased Clonazepam SS ORAL PO

Coagulation Factor X Interferon Alfa-2b SS SUBCUTANEOUS SC

Level Decreased

Coagulation Time

Prolonged

Disseminated

Intravascular Coagulation

Fibrinolysis

Hepatic Failure

Hepatic Steatosis

Mean Cell Volume

Decreased

Prothrombin Level

Decreased

Date:01/12/05ISR Number: 4551981-7Report Type:Expedited (15-DaCompany Report #A02200403854 Age:87 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Condition Aggravated Health Calciparine PS Sanofi SUBCUTANEOUS 0.3 ML TID,

Initial or Prolonged Renal Cyst Professional SUBCUTANEOUS

Renal Failure Acute Xatral - (Alfuzosin)

- Tablet SS ORAL ORAL

Kayexalate (Sodium

Polystyrene

Sulfonate) - Powder

- 15 Mg SS

Cortancyl

(Prednisone) -

Tablet - 5mg SS ORAL 5 MG OD, ORAL

18-Apr-2007 11:25 AM Page: 78

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Lasilix -

(Furosemide) -

Tablet - 20 Mg SS ORAL 20 MG OD,

ORAL

Chloraminophene

"Techni-Pharma" -

(Chlorambucil) -

Capsule - 2 Mg SS Techni-Pharma ORAL 2 MG 3/WEEK,

ORAL

Mopral -

(Omeprazole) -

Capsule - 20 Mg SS ORAL 20 MG OD,

ORAL

Dafalgan -

(Paracetamol) -

Capsule - 500 Mg SS

Forlax - (Macrogol)

- Powder - 10 G SS ORAL IG TID

Imovane -

(Zopiclone) - Tablet SS ORAL ORAL

Bricanyl -

(Terbutaline

Sulfate) SS RESPIRATORY

(INHALATION) RESPIRATORY

(INHALATION)

Date:01/13/05ISR Number: 4553233-8Report Type:Expedited (15-DaCompany Report #2005CG00034 Age:87 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Condition Aggravated Foreign Mopral PS ORAL 20 MG DAILY

Initial or Prolonged Haemorrhage Health PO

Renal Cyst Professional Bricanyl SS

Renal Failure Acute Other Cortancyl SS ORAL 5 MG DAILY PO

Thrombophlebitis Choraminophene SS "Techni-Pharma" ORAL 2 MG TIWK PO

Calciparine SS Sanofi 0.3 ML TID SQ

Dafalgan SS ORAL 1 G TID PO

Xatral - Slow

Release SS

Lasilix SS ORAL 20 MG DAILY

PO

Forlax SS

Imovane SS

Kayexelate SS

Date:01/14/05ISR Number: 4556739-0Report Type:Expedited (15-DaCompany Report #050002 Age:11 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Medical Device Health Golytely PS

Complication Professional

Vomiting

18-Apr-2007 11:25 AM Page: 79

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:01/14/05ISR Number: 4556742-0Report Type:Expedited (15-DaCompany Report #050001 Age:62 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Dyspnoea Health Halflytely And

Initial or Prolonged Hypotension Professional Bisacodyl Tablets

Urticaria Bowel Prep Kit PS 20 MG/2 L

Zocor C

Lisinopril C

Toporol C

Plavix C

Aspirin C

Folic Acid C

Fish Oil C

Naproxin C

Date:01/14/05ISR Number: 4556822-XReport Type:Expedited (15-DaCompany Report #2005-124010-NL Age:79 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Anaemia Mirtazapine PS ORAL 30 MG 375 DAY

Initial or Prolonged Depression Pepsane SS ORAL 2 DF 16 DAY

Gastric Ulcer Macrogol SS ORAL 5.9 MG 16 DAY

Hyponatraemia Rabeprazole Sodium SS ORAL 20 MG 19 DAY

Nausea Domperidone SS ORAL 10 MG 23 DAY

Treatment Noncompliance Loprazolammesilate C

Vomiting Lithium Bromide C

Sotalol

Hydrochloride C

Irbesartan C

Date:01/19/05ISR Number: 4558743-5Report Type:Expedited (15-DaCompany Report #040066 Age:58 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Colitis Ischaemic Consumer Halflytely And

Pain Bisacodyl Tablets

Vomiting Bowel Prep Kit PS 20 MG/2 LITER

Aciphex C

Date:01/19/05ISR Number: 4678717-3Report Type:Direct Company Report #CTU 237091 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Abdominal Pain Miralax (Generic

Constipation Peg) PS ORAL 17G PO BID

Pharmaceutical Product Dicyclomine C

Complaint

Date:01/19/05ISR Number: 4678719-7Report Type:Direct Company Report #CTU 237092 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Drug Ineffective Miralax Powder PS ONE TABLET IN

Flatulence WATER QD

Pharmaceutical Product

Complaint

18-Apr-2007 11:25 AM Page: 80

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:01/24/05ISR Number: 4560075-6Report Type:Expedited (15-DaCompany Report #2005012810 Age:62 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Drug Ineffective Consumer Visine Tears (

Eyelid Operation Glycerin,

Infection Polyethylene Glycol,

Hydroxypropylmethylc

ellulose) PS OPHTHALMIC 4-6 TIMES

DAILY,

OPHTHALMIC

Vitamins (Vitamiins) C

Calcium (Calcium) C

Date:01/26/05ISR Number: 4569075-3Report Type:Direct Company Report #CTU 238113 Age:70 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Drug Effect Decreased Generic Miralax PS 17 GRAMS IN 8

Pharmaceutical Product Q OF WATER

Complaint

Date:01/28/05ISR Number: 4576934-4Report Type:Direct Company Report #CTU 238555 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Drug Ineffective Glycolax 3350 Nf

Pharmaceutical Product Powder PS ORAL USE 1 CAPFUL

Complaint ONCE/TWICE

DAILY BY

MOUTH

Fiber Tabs C

Docusate Sodium C

Date:02/02/05ISR Number: 4578472-1Report Type:Direct Company Report #CTU 238846 Age:71 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Abdominal Discomfort Glycolax PS

Abdominal Distension Miralax SS

Constipation

Drug Ineffective

Pharmaceutical Product

Complaint

Date:02/04/05ISR Number: 4699660-XReport Type:Direct Company Report #CTU 239374 Age: Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Required Abdominal Distension Miralax 17 Gm/Day PS

Intervention to Abdominal Pain

Prevent Permanent Drug Ineffective

Impairment/Damage Pharmaceutical Product

Complaint

18-Apr-2007 11:25 AM Page: 81

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:02/07/05ISR Number: 4699724-0Report Type:Direct Company Report #CTU 239411 Age: Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Drug Effect Decreased Glycolax PS ORAL 2T PO DAY

Pharmaceutical Product

Complaint

Date:02/08/05ISR Number: 4576969-1Report Type:Expedited (15-DaCompany Report #050005 Age: Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Bipolar Disorder Consumer Polyethylene Glucol

Suicide Attempt 3350, Nf Powder For

Solution PS

Bipolar Medication C

Date:02/08/05ISR Number: 4703504-7Report Type:Direct Company Report #CTU 239582 Age:6 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other No Therapeutic Response Glycolax PS 17 GRAMS

Therapeutic Response BIRTH 8OZ

Unexpected With Drug THEN 5 Q AM

Substitution

Date:02/08/05ISR Number: 4703695-8Report Type:Direct Company Report #CTU 239595 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Pharmaceutical Product Miralax PS 1 TBSP PER

Complaint G-TUBE

Date:02/09/05ISR Number: 4577927-3Report Type:Expedited (15-DaCompany Report #30044 Age:74 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Cataract Operation Health Bss Plus Solutoin

Initial or Prolonged Complication Professional (Batch #S: 5072f,

Corneal Disorder 1215f) PS IO 1 DAY

Corneal Opacity

Descemet'S Membrane

Disorder

Ocular Hypertension

Pigment Dispersion

Syndrome

Pupillary Disorder

Date:02/09/05ISR Number: 4577928-5Report Type:Expedited (15-DaCompany Report #30041 Age:81 YR Gender:Female I/FU:I

Outcome PT

Hospitalization - Cataract Operation

Initial or Prolonged Complication

Corneal Disorder

Corneal Opacity

Descemet'S Membrane

18-Apr-2007 11:25 AM Page: 82

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Disorder

Injury Corneal

Medical Device

Complication Report Source Product Role Manufacturer Route Dose Duration

Medication Error Health Bss Plus Solution

Pigment Dispersion Professional Irrigation Solution

Syndrome (Batch #S: 5072f,

Visual Disturbance 1215f) PS IO 1 DAY

Date:02/09/05ISR Number: 4577929-7Report Type:Expedited (15-DaCompany Report #29980 Age:63 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Cataract Operation Health Bss Plus Solution

Complication Professional Irrigation Solution

Corneal Oedema (Batch #S: 1215f,

Descemet'S Membrane 5072f) PS IO 1 DAY

Disorder

Flat Anterior Chamber Of

Eye

Hypopyon

Hypotony Of Eye

Medical Device

Complication

Medication Error

Date:02/10/05ISR Number: 4580080-3Report Type:Expedited (15-DaCompany Report #050005 Age:17 YR Gender:Male I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Suicide Attempt Consumer Polyethylene Glycol

3350, Nf Powder For

Solution PS ORAL 17G/BID (AM &

PM) /PO

Bipolar Medication

(Believed To Be A

Combination Therapy

Of Tryptanol &

Propec) C

Date:02/15/05ISR Number: 4587511-3Report Type:Expedited (15-DaCompany Report #2005024994 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Cataract Operation Consumer Visine Tears

(Glycerin,

Polyethylene Glycol,

Hydroxypropylmethylc

ellulose) PS OPHTHALMIC "COUPLE OF

DROPS PER

EYE" 1-2X /

DAY,

OPHTHALMIC

Murine (Berberine

Hydrochloride, Boric

Acid, Hydrastine

Hydrochloride) SS UNSPECIFIED,

OPHTHALMIC

Desloratadine

18-Apr-2007 11:25 AM Page: 83

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

(Desloratadine) C

Co-Dioven

(Hydrochlorothiazide

, Valsartan) C

Esomeprazole

(Esomeprazole) C

Oemprazole

(Omeprazole) C

Date:02/16/05ISR Number: 4586877-8Report Type:Direct Company Report #CTU 240561 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Abdominal Pain Glycolax PS ORAL 3 GM BID PO

Fatigue

Nausea

Rectal Haemorrhage

Date:02/18/05ISR Number: 4590517-1Report Type:Direct Company Report #CTU 240823 Age:76 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Constipation Polyethylene Gi 3350

Drug Ineffective Pwd 527 G Affordable

Pharmaceutical Product Pharm PS Affordable Pharm 1 SCOOP DAILY

Complaint Zocor C

Niaspan Er C

Advair Diskus C

Date:02/22/05ISR Number: 4592500-9Report Type:Expedited (15-DaCompany Report #2005016630 Age:76 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Blood Glucose Increased Consumer Detrol La Capsule,

Initial or Prolonged Eating Disorder Prolonged Release

Heart Rate Decreased (Tolterodine

Insomnia L-Tartrate) PS ORAL 4 MG (4 MG,

Prothrombin Time QD), ORAL

Prolonged Norvasc (Amlodipine

Besilate)(Amlodipine

) SS ORAL 10 MG (10 MG,

DAILY), ORAL

Warfarin Sodium

(Warfarin Sodium) SS ORAL ORAL

Metoprolol Succinate

(Metoprolol

Succinate) SS ORAL ORAL

Hydrochlorothiazide

(Hydrochlorothiazide

) SS ORAL ORAL

Simvastatin

(Simvastatin) SS ORAL ORAL

Acetylsalicylic Acid

(Acetylsalicylic

Acid) SS ORAL ORAL

Lisinopril

(Lisinopril) SS ORAL ORAL

Glipizide

(Glipizide) SS ORAL ORAL

18-Apr-2007 11:25 AM Page: 84

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Sodium Bicarbonate

(Sodium Bicarbonate) SS ORAL ORAL

Macrogol (Macrogol) SS ORAL ORAL

Alfuzoxin

Hydrochloride

(Alfuzosin

Hydrochloride) SS ORAL ORAL

Insulin (Insulin) SS

Lansoprazole

(Lansoprazole) C

Cetirizine

Hydrochloride

(Cetirizine

Hydrochloride) C

Date:03/01/05ISR Number: 4598119-8Report Type:Direct Company Report #CTU 241748 Age:73 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Drug Effect Decreased Polyethylene Gi 3350

Pwd 527g Affordable

Pharm PS Affordable Pharm ORAL 17 GMS PO

Q./8 OUNCES

WATER DAILY

Date:03/02/05ISR Number: 4599311-9Report Type:Direct Company Report #CTU 241781 Age:33 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Drug Ineffective Glycolax PS

Pharmaceutical Product

Complaint

Date:03/03/05ISR Number: 4599634-3Report Type:Expedited (15-DaCompany Report #050013 Age:73 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Haemorrhage Health Nulytely PS ORAL 3 DUCOLAX,

Professional 1X, PO; 4L,

1X, PO

Blood Pressure And

Cholesterol

Medication C

Date:03/04/05ISR Number: 4598361-6Report Type:Expedited (15-DaCompany Report #200414279FR Age:69 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Condition Aggravated Lovenox PS Aventis

Initial or Prolonged Pulmonary Hypertension Pharmaceuticals Inc. SUBCUTANEOUS

Tracleer SS ORAL

Primperan SS ORAL

Skenan SS ORAL

Effexor SS ORAL

Omeprazole SS ORAL

Movicol SS

18-Apr-2007 11:25 AM Page: 85

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:03/04/05ISR Number: 4600535-2Report Type:Expedited (15-DaCompany Report #050016 Age:30 MON Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Convulsion Consumer Miralax PS ORAL PO 6 MON

Seizure Medication C

Date:03/04/05ISR Number: 4600537-6Report Type:Expedited (15-DaCompany Report #050015 Age:44 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Asthma Consumer Halflytely And

Feeling Abnormal Bisacodyl Tablets

Rash Bowel Prep Kit PS ORAL 20MG/2L, 1X,

Vomiting PO

Synthroid C

Date:03/10/05ISR Number: 4606724-5Report Type:Expedited (15-DaCompany Report #2005016630 Age:76 YR Gender:Male I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Adverse Event Consumer Detrol La Capsule,

Initial or Prolonged Blood Glucose Increased Prolonged Release

Blood Pressure Decreased (Tolterodine

Drug Effect Decreased L-Tartrate) PS ORAL 4 MG (4

Heart Rate Decreased MG,QD), ORAL

Hyperhidrosis Norvasc (Amlodipine

Insomnia Besilate)

Prothrombin Time (Amlodipine) SS ORAL 10 MG (10 MG,

Prolonged DAILY), ORAL

Urinary Incontinence Warfarin Sodium

(Warfarin Sodium) SS ORAL ORAL

Metoprolol Succinate

(Metoprolol

Succinate) SS ORAL ORAL

Hydrochlorothiazide

(Hydrochlorothiazide

) SS ORAL ORAL

Simvastatin

(Simvastatin) SS ORAL ORAL

Acetylsalicylic Acid

(Acetylsalicylic

Acid) SS ORAL ORAL

Lisinopril

(Lisinopril) SS ORAL ORAL

Glucotrol

(Glipizide)

(Glipizide) SS ORAL ORAL

Sodium Bicarbonate

(Sodium Bicarbonate) SS ORAL ORAL

Macrogol (Macrogol) SS ORAL ORAL

Alfuzosin

Hydrochloride

(Alfuzosin

Hydrochloride) SS ORAL ORAL

Insulin (Insulin) SS UNKNOWN UNKNOWN

Lansoprazole

(Lansoprazole) C

Cetirizine

Hydrochloride

18-Apr-2007 11:25 AM Page: 86

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

(Cetirizine

Hydrochloride) C

Date:03/11/05ISR Number: 4679467-XReport Type:Direct Company Report #CTU 242998 Age: Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Constipation Glycolax PS 1/2 CAPFUL

Diarrhoea DAILY MIXED

Therapeutic Response W/ WATER PER

Unexpected With Drug NG TUBE

Substitution

Date:03/11/05ISR Number: 4679619-9Report Type:Direct Company Report #CTU 243021 Age:26 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Diarrhoea Glycolax 17 G Q Day PS RECENTLY

Infrequent Bowel

Movements

Therapeutic Response

Unexpected With Drug

Substitution

Date:03/11/05ISR Number: 4679636-9Report Type:Direct Company Report #CTU 243038 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Abdominal Pain Polyethylene Glycol PS 1/2 CAPFUL QD

Diarrhoea

Pharmaceutical Product

Complaint

Skin Irritation

Date:03/11/05ISR Number: 4689438-5Report Type:Direct Company Report #CTU 242755 Age: Gender: I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Change Of Bowel Habit Glycolax PS 17Q/ 4MG @ HS

Drug Ineffective

Date:03/15/05ISR Number: 4610208-8Report Type:Expedited (15-DaCompany Report #2005038450 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Cataract Consumer Visine Tears

(Glycerin,

Polyethylene Glycol,

Hydroxypropylmethylc

ellulose) PS OPHTHALMIC 1 DROP, EACH

EYE, TWICE

DAILY,

OPHTHALMIC

Valsartan

(Valsartan) C

Atenolol (Atenolol) C

18-Apr-2007 11:25 AM Page: 87

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:03/17/05ISR Number: 4615402-8Report Type:Expedited (15-DaCompany Report #050013 Age:73 YR Gender:Male I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Colitis Ischaemic Health Nulytely PS ORAL 3 DULCOLAX,

Haemorrhage Professional 1X, PO

Blood Pressure C

Cholesterol

Medication C

Date:03/17/05ISR Number: 4615628-3Report Type:Expedited (15-DaCompany Report #L04-USA-07403-02 Age:53 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Anoxic Encephalopathy Literature Levothyroxine PS

Cerebral Infarction Health Ethylene Glycol

Coma Professional (Polyethylene

Completed Suicide Glycol) SS

Dizziness Gabapentin SS

Loss Of Consciousness Paroxetine SS

Metabolic Acidosis Rofecoxib SS

Multiple Drug Overdose Trazodone SS

Intentional Lovastatin SS

Mydriasis Clonazepam SS

Lorazepam SS

Benazepril SS

Lansoprazole SS

Medroxyprogesterone SS

Aspirin SS

Date:03/18/05ISR Number: 4613532-8Report Type:Direct Company Report #CTU 243724 Age:10 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Abdominal Pain Glycolax PS 17 GM DAILY

Faecal Volume Increased

Flatulence

Infrequent Bowel

Movements

Date:03/18/05ISR Number: 4613666-8Report Type:Direct Company Report #CTU 243774 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

No Adverse Drug Effect Miralax Powder PS AS DIRECTED

Date:03/18/05ISR Number: 4614871-7Report Type:Direct Company Report #CTU 243570 Age: Gender: I/FU:I

Outcome PT

Abdominal Pain

Burning Sensation

Cardiac Disorder

Cholecystitis

Diarrhoea Haemorrhagic

Dyspepsia

Gastrointestinal Pain

Pharmaceutical Product

18-Apr-2007 11:25 AM Page: 88

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Complaint

Throat Irritation

Report Source Product Role Manufacturer Route Dose Duration

Miralax PS 2 YR

Date:03/22/05ISR Number: 4617854-6Report Type:Expedited (15-DaCompany Report #863#1#2005-00001 Age:50 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Asthenia Foreign Idrolax (Macrogol) PS ORAL 1.4 SACHETS/4

Initial or Prolonged Chills Health LITERES ORAL 4 HR

Dyspnoea Professional

Face Oedema Other

Hyperhidrosis

Nausea

Vomiting

Date:03/23/05ISR Number: 4618641-5Report Type:Expedited (15-DaCompany Report #050024 Age:40 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Abdominal Pain Health Cherry Flavor

Blood Test Abnormal Professional Nulytely PS

Dehydration Other

Fatigue

Heart Rate Decreased

Heart Rate Irregular

Lipase Increased

Skin Odour Abnormal

Date:03/23/05ISR Number: 4619952-XReport Type:Direct Company Report #CTU 244058 Age:58 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Abdominal Distension Miralax PS

Pain

Pharmaceutical Product

Complaint

Date:03/23/05ISR Number: 4619988-9Report Type:Direct Company Report #CTU 244035 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Abdominal Distension Glucolax PS 17 GRAMS

Muscle Spasms DAILY

Pharmaceutical Product

Complaint

Date:03/23/05ISR Number: 4621260-8Report Type:Direct Company Report #CTU 244031 Age:46 YR Gender:Female I/FU:I

Outcome PT

Other Abdominal Distension

Abdominal Pain

Constipation

Pharmaceutical Product

18-Apr-2007 11:25 AM Page: 89

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Complaint

Report Source Product Role Manufacturer Route Dose Duration

Miralax (Generic) PS 1-2

SCOOP/DAILY

X 6 MONTHS

Date:03/24/05ISR Number: 4620577-0Report Type:Expedited (15-DaCompany Report #050026 Age:56 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Anaphylactic Reaction Consumer Halflytely And

Initial or Prolonged Dyspnoea Bisacodyl Tablets

Heart Rate Decreased Bowel Prep Kit PS 20 MG/2 L

Synthroid C

Toprol C

Plavix C

Niaspan C

Date:03/24/05ISR Number: 4620582-4Report Type:Expedited (15-DaCompany Report #050016 Age:30 MON Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Convulsion Consumer Miralax PS ORAL PO 6 MON

Seizure Medication C

Date:03/24/05ISR Number: 4622307-5Report Type:Direct Company Report #CTU 244180 Age:92 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Abdominal Pain Glycolax PS ORAL 1 SCOOP

Therapeutic Product ORALLY ONCE

Ineffective DAILY

Date:03/29/05ISR Number: 4622727-9Report Type:Direct Company Report #CTU 244578 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Life-Threatening Fall Halflytely

Head Injury (Bisacodyl)

Syncope Braintree

Laboratories PS Braintree

Laboratories ORAL 4 TABS ONCE

ORAL

.. C

Date:03/30/05ISR Number: 4623643-9Report Type:Expedited (15-DaCompany Report #002#4#2005-00084 Age:73 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Colitis Ischaemic Health Trilyte-With-Flavor-

Required Post Procedural Professional Packs (Polyethylene

Intervention to Haemorrhage Other Glycol 335

Prevent Permanent Bisacodyl) PS ORAL 1 ONCE; ORAL

Impairment/Damage Bisacodyl SS 3 IN 1 ONCE,

18-Apr-2007 11:25 AM Page: 90

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:03/30/05ISR Number: 4624343-1Report Type:Direct Company Report #CTU 244784 Age:56 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Abdominal Pain Miralax (Generic) PS ONE TBSP BID

Anorexia

Constipation

Pharmaceutical Product

Complaint

Date:03/30/05ISR Number: 4624348-0Report Type:Direct Company Report #CTU 244780 Age: Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Abdominal Pain Polyethylene Glycol PS ORAL 1 CAPFUL QD

Diarrhoea ORALLY

Flatulence

Incontinence

Pain

Pharmaceutical Product

Complaint

Date:03/31/05ISR Number: 4656630-5Report Type:Periodic Company Report #US100455 Age:56 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Chest Discomfort Health Neulasta - Prefilled

Discomfort Professional Syringe PS INTRAVENOUS 6 MG, 1 IN 1

Flushing DAYS, IV

Hypotension Polyethylene Glycol SS

Medication Error Cyclophosphamide C

Tachycardia Doxorubicin

Hydrochloride C

Vincristine Sulfate C

Prednisone C

Rituximab C

Date:04/07/05ISR Number: 4631179-4Report Type:Direct Company Report #CTU 245580 Age:56 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Constipation Miralax (Generic) PS 17 GM /H2O

DAILY

Date:04/07/05ISR Number: 4631192-7Report Type:Direct Company Report #CTU 245634 Age:58 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Abdominal Distension Miralax PS

Pain

Date:04/07/05ISR Number: 4631204-0Report Type:Direct Company Report #CTU 245600 Age:7 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Constipation Glycolax 3350

Ileus Powder PS ORAL TBSP TID PO

18-Apr-2007 11:25 AM Page: 91

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:04/13/05ISR Number: 4635839-0Report Type:Expedited (15-DaCompany Report #050029 Age:64 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Blood Potassium Abnormal Consumer Golytely PS ORAL 4L , 1X, PO

Initial or Prolonged Infrequent Bowel

Movements

Date:04/14/05ISR Number: 4636677-5Report Type:Expedited (15-DaCompany Report #GBR-2005-0001625 Age:78 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - C-Reactive Protein Foreign Oxycontin Tablets 10

Initial or Prolonged Increased Health Mg (Oxycondone

Inflammation Professional Hydrochloride) Cr

Pruritus Other Tablet PS ORAL 20 MG, DAILY,

Rash Morbilliform ORAL

Movicol (Sodium

Bicarbonate,

Potassium Chloride,

Sodium Chloride,

Macrogol) SS ORAL 1 UNIT,

DAILY, ORAL

Keppra

(Levetiracetam) SS ORAL 1 GRAM,

DAILY, ORAL

Valproic Acid SS ORAL ORAL

Neurontin

(Gabapentin) SS ORAL ORAL

Praxilene

(Naftidrofuryl

Oxalate) SS

Mopral (Omeprazole) SS ORAL 20 MG, DAILY,

ORAL

Profenid "Rhone

Poulenc"

(Ketoprofen) SS ORAL 100 MG,

DAILY, ORAL

Date:04/15/05ISR Number: 4637992-1Report Type:Expedited (15-DaCompany Report #050026 Age:56 YR Gender:Male I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Anaphylactic Reaction Consumer Halflytley And

Initial or Prolonged Dyspnoea Bisacodyl Tablets

Heart Rate Decreased Bowel Prep Kit PS 20 MG/ 2 L

Lung Infection Synthroid C

Oral Fungal Infection Toprol C

Total Lung Capacity Plavix C

Decreased Niaspan C

Date:04/19/05ISR Number: 4641192-9Report Type:Direct Company Report #CTU 246484 Age: Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Constipation Glycolax Powder PS 17 GRAMS IN 8

OZ OF WATER

TAKE 15 ML

DAILY

18-Apr-2007 11:25 AM Page: 92

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:04/21/05ISR Number: 4642172-XReport Type:Expedited (15-DaCompany Report #002#4#2005-00084 Age:73 YR Gender:Male I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Colitis Ischaemic Health Trilyte-With-Flavor-

Required Post Procedural Professional Packs (Polyethylene

Intervention to Haemorrhage Other Glycol 3350) PS ORAL 41, 1ONCE,

Prevent Permanent ORAL

Impairment/Damage Bisacodyl SS ORAL 3 IN 1 D ORAL

Unspecified

Concomitant Drugs C

Date:04/22/05ISR Number: 4642948-9Report Type:Expedited (15-DaCompany Report #FR-ABBOTT-05P-056-0297333-00 Age:78 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - C-Reactive Protein Micropakine Granule PS ORAL

Initial or Prolonged Increased Profenid SS ORAL 2 DAY

Rash Morbilliform Nulytely SS ORAL 8 DAY

Systemic Inflammatory Levetiracetam SS ORAL

Response Syndrome Oxycodone

Hydrochloride SS ORAL 9 DAY

Omeprazole SS ORAL 4 DAY

Gabapentin SS ORAL

Naftidrofuryl

Oxalate SS ORAL

Date:04/22/05ISR Number: 4644895-5Report Type:Expedited (15-DaCompany Report #050042 Age:75 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Dehydration Consumer Halflytely And

Initial or Prolonged Diarrhoea Bisacodyl Tablets

Loss Of Consciousness Bowel Prep Kit PS ORAL 20 MG, 1X, PO

Refusal Of Treatment By High Blood Pressure

Patient Med C

Vomiting

Date:04/22/05ISR Number: 4644900-6Report Type:Expedited (15-DaCompany Report #050031 Age:52 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Loss Of Consciousness Health Halflytely And

Skin Injury Professional Bisacodyl Tablets

Syncope Bowel Prep Kit PS ORAL 20 MG, 1X, PO

Calcium C

Aleve(Occasionally) C

Date:04/22/05ISR Number: 4645096-7Report Type:Expedited (15-DaCompany Report #050035 Age:35 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Hypoglycaemia Health Nulytely PS ORAL 4L/1X/PO

Tremor Professional

18-Apr-2007 11:25 AM Page: 93

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:04/22/05ISR Number: 4645921-XReport Type:Direct Company Report #CTU 246888 Age: Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Constipation Glycolax Powder PS 17 GRAMS IN

8OZ OF WATER

TAKE 15 ML

DAILY

Date:04/26/05ISR Number: 4647806-1Report Type:Expedited (15-DaCompany Report #05P-056-0297333-00 Age:78 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Rash Morbilliform Foreign Micropakine Granule

Initial or Prolonged Systemic Inflammatory Health (Sodium Valproate)

Response Syndrome Professional (Sodium Valproate) PS ORAL ORAL

Profenid

(Ketoprofen)

(Ketoprofen) SS ORAL 100 MG, 1 IN

1 D ORAL

Nulytely SS ORAL 13.125 GM, 1

IN 1 D ORAL

Levetiracetam SS ORAL 1 GM, 1 IN 1

D ORAL

Oxycodone

Hydrochloride SS ORAL 20 MG, 1 IN 1

D, ORAL

Omeprazole SS ORAL 20 MG, 1 IN 1

D, ORAL

Gabapentin SS ORAL ORAL

Naftidrofuryl

Oxalate SS ORAL ORAL

Date:04/28/05ISR Number: 4649499-6Report Type:Direct Company Report #CTU 247347 Age:53 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Abdominal Pain Upper Golytely 4000ml

Flushing Braintree Labs PS Braintree Labs ORAL AS ORDERED

Migraine MIXED WITH

Pharmaceutical Product ORAL

Complaint Nulytely SS Braintree Labs ORAL AS ORDERED

ORAL

Date:04/28/05ISR Number: 4650655-1Report Type:Direct Company Report #CTU 247389 Age: Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Drug Effect Decreased Generic Miralax PS 17 GM DAILY

Therapeutic Response

Unexpected With Drug

Substitution

18-Apr-2007 11:25 AM Page: 94

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:05/02/05ISR Number: 4652368-9Report Type:Expedited (15-DaCompany Report #050045 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Hypokalaemia Health Halflytely And

Initial or Prolonged Hypomagnesaemia Professional Bisacodyl Tablets

Hyponatraemia Bowel Prep Kit PS ORAL 20 MG/1L, 1X,

Hypotension PO

Date:05/02/05ISR Number: 4653094-2Report Type:Expedited (15-DaCompany Report #050046 Age:50 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Colitis Ischaemic Consumer Halflytely And

Health Bisacodyl Tablets

Professional Bowel Prep Kit PS ORAL 20 MG/2L, 1X,

PO

Date:05/04/05ISR Number: 4653345-4Report Type:Direct Company Report #CTU 247685 Age: Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Drug Ineffective Miralax Generic PS

Date:05/04/05ISR Number: 4654512-6Report Type:Direct Company Report #CTU 247767 Age:83 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Drug Effect Decreased Polyethylene Glycol

Pharmaceutical Product 3350 Pwd 527g PS Affordable Pharm MIX ONE

Complaint CAPFUL (17

Therapeutic Response GRAMS) IN 80Z

Unexpected With Drug OF WATER AND

Substitution DRINK AS

Carbidopa/Levo C

Lexapro C

Warfarin C

Date:05/05/05ISR Number: 4655123-9Report Type:Expedited (15-DaCompany Report #863#2#2005-00004 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Abdominal Operation Idrolax (Macrogol) PS ORAL 1.40 G (10

Initial or Prolonged Abdominal Pain G/1 4 IN 4

Anal Fissure HOUR (S) 4 HR

Asthenia

Frequent Bowel Movements

Intestinal Perforation

Nausea

Date:05/05/05ISR Number: 4655133-1Report Type:Expedited (15-DaCompany Report #863#8#2005-00003 Age:50 YR Gender:Male I/FU:I

Outcome PT

Hospitalization - Condition Aggravated

Initial or Prolonged Gastrointestinal Oedema

Intestinal Ischaemia

18-Apr-2007 11:25 AM Page: 95

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Intestinal Strangulation

Post Procedural

Complication Report Source Product Role Manufacturer Route Dose Duration

Rectal Prolapse Literature Idrolax (Macrogol) PS ORAL 1.3 LITRES

TOTAL VOLUME 3 HR

Antidepressants C

Beta Blockers C

Date:05/05/05ISR Number: 4655475-XReport Type:Expedited (15-DaCompany Report #050047 Age:66 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Colitis Ischaemic Health Halflytely And

Initial or Prolonged Large Intestinal Professional Bisacodyl Tablets

Haemorrhage Bowel Prep Kit PS ORAL 20 MG/2L, 1X,

PO

Protonix C

Metamucil C

Diovan C

Zetia C

Aspirin C

Date:05/06/05ISR Number: 4656627-5Report Type:Expedited (15-DaCompany Report #8009828 Age:78 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Inflammation Foreign Keppra PS ORAL 1000 MG /D PO

Initial or Prolonged Rash Morbilliform Health Movicol SS ORAL 1 DF /D PO

Professional Oxycontin SS ORAL 20 MG /D PO

Other Depakine SS ORAL PO

Mopral SS ORAL 20 MG / D PO

Profenid SS ORAL 100 MG / D PO

Neurontin SS ORAL PO

Praxilene SS ORAL PO

Date:05/09/05ISR Number: 4658668-0Report Type:Expedited (15-DaCompany Report #GBR-2005-0001625 Age:78 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - C-Reactive Protein Foreign Oxycontin Tablets 10

Initial or Prolonged Increased Health Mg (Oxycodone

Inflammation Professional Hydrochloride) Cr

Rash Morbilliform Other Tablet PS ORAL 20 MG, DAILY,

ORAL

Movicol(Sodium

Bicarbonate,

Potassium Chloride,

Sodium Chloride,

Macrogol) SS ORAL 1 UNIT,

DAILY, ORAL

Keppra

(Levetiracetam) SS ORAL 1 GRAM DAILY,

ORAL

Valproic Acid

(Valproic Acid) SS ORAL ORAL

Mopral (Omeprazole) SS ORAL 20 MG, DAILY,

ORAL

Profenid

18-Apr-2007 11:25 AM Page: 96

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

"Rhone-Poulenc"

(Ketoprofen) SS Rhone-Poulenc ORAL 100 MG,

DAILY, ORAL

Neurontin

(Gabapentin) SS ORAL ORAL

Praxilene

(Naftidrofuryl

Oxalate) SS ORAL ORAL

Date:05/10/05ISR Number: 4658419-XReport Type:Direct Company Report #CTU 248144 Age:4.75 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Drug Ineffective Glycolax PS 2TS DAILY

Pharmaceutical Product Miralax C

Complaint

Date:05/11/05ISR Number: 4661037-0Report Type:Expedited (15-DaCompany Report #050049 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Intestinal Perforation Health Halflytely And

Post Procedural Professional Bisacodyl PS

Complication

Post Procedural

Haemorrhage

Procedural Pain

Date:05/11/05ISR Number: 4661038-2Report Type:Expedited (15-DaCompany Report #050050 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Colitis Health Halflytely And

Initial or Prolonged Post Procedural Professional Bisacodyl PS

Haemorrhage

Procedural Pain

White Blood Cell Count

Increased

Date:05/12/05ISR Number: 4660662-0Report Type:Expedited (15-DaCompany Report #FR-ABBOTT-05P-056-0297333-00 Age:78 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - C-Reactive Protein Micropakine Granule PS ORAL

Initial or Prolonged Increased Profenid SS ORAL 2 DAY

Rash Morbilliform Nulytely SS ORAL 8 DAY

Systemic Inflammatory Levetiracetam SS ORAL

Response Syndrome Oxycodone

Hydrochloride SS ORAL 9 DAY

Omeprazole SS ORAL 4 DAY

Gabapentin SS ORAL

Naftidrofuryl

Oxalate SS ORAL

18-Apr-2007 11:25 AM Page: 97

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:05/16/05ISR Number: 4663826-5Report Type:Expedited (15-DaCompany Report #050046 Age:50 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Colitis Ischaemic Consumer Halflytely And

Pain Health Bisacodyl Tablets

Professional Bowel Prep Kit PS ORAL 20 MG/2L, 1X,

PO

Date:05/18/05ISR Number: 4665404-0Report Type:Direct Company Report #CTU 248957 Age:4.75 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Pharmaceutical Product Glycolax PS 2 TS DAILY

Complaint . C

Therapeutic Response

Unexpected With Drug

Substitution

Date:05/20/05ISR Number: 4669536-2Report Type:Expedited (15-DaCompany Report #2005072871 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Melanosis Consumer Visine Tears

Ocular Neoplasm Preservative Free

(Glycerin,

Polyethylene Glycol,

Hydroxyproplymethylc PS OPHTHALMIC OPHTHALMIC

Corticosteroid Nos

(Corticosteroid Nos) SS OPHTHALMIC OPHTHALMIC

Date:05/24/05ISR Number: 4674107-8Report Type:Direct Company Report #CTU 249394 Age:58 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Blood Pressure Systolic Golytely PS

Initial or Prolonged Decreased Aldactone SS

Required Dehydration Furosemide SS

Intervention to Dizziness Postural

Prevent Permanent Hyperkalaemia

Impairment/Damage Hypotension

Polyuria

Renal Failure Acute

Date:05/25/05ISR Number: 4673773-0Report Type:Expedited (15-DaCompany Report #FR-ABBOTT-05P-056-0297333-00 Age:78 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - C-Reactive Protein Micropakine Granule PS ORAL

Initial or Prolonged Increased Profenid SS ORAL 2 DAY

Rash Morbilliform Nulytely SS ORAL 8 DAY

Systemic Inflammatory Levetiracetam SS ORAL

Response Syndrome Oxycodone

Hydrochloride SS ORAL 9 DAY

Omeprazole SS ORAL 4 DAY

Gabapentin SS ORAL

Naftidrofuryl

Oxalate SS ORAL

18-Apr-2007 11:25 AM Page: 98

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:05/26/05ISR Number: 4677369-6Report Type:Direct Company Report #CTU 249707 Age:12 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Abscess Glycolax Kremers

Initial or Prolonged Constipation Urban PS

Medication Error

Pharmaceutical Product

Complaint

Date:06/10/05ISR Number: 4691285-5Report Type:Expedited (15-DaCompany Report #050042 Age:75 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Dehydration Consumer Halflytely And

Initial or Prolonged Diarrhoea Bisacodyl Tablets

Drug Ineffective Bowel Prep Kit PS ORAL 20 MG, 1X, PO

Dysphagia High Blood Pressure

Hypertonic Bladder Med C

Loss Of Consciousness

Refusal Of Treatment By

Patient

Vomiting

Date:06/15/05ISR Number: 4691403-9Report Type:Expedited (15-DaCompany Report #002#3#2005-00179 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Abscess Health Glycolax

Initial or Prolonged Drug Ineffective Professional (Polyethylene Glycol

Drug Level Changed Other 3350) PS

Pharmaceutical Product

Complaint

Date:06/16/05ISR Number: 4694007-7Report Type:Expedited (15-DaCompany Report #050062 Age:78 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Diarrhoea Consumer Miralax/Glycolax

Initial or Prolonged Rash Generalised (Generic) PS ORAL 17 G, DAILY,

Weight Decreased PO

Date:06/17/05ISR Number: 4693902-2Report Type:Expedited (15-DaCompany Report #FR-MERCK-0506FRA00047 Age:93 YR Gender:Female I/FU:I

Outcome PT

Life-Threatening Abdominal Mass

Hospitalization - Acute Myocardial

Initial or Prolonged Infarction

Arrhythmia

Cardio-Respiratory Arrest

Cardiogenic Shock

Dehydration

Diarrhoea

Disease Recurrence

Hypernatraemia

Hypokalaemia

Iron Deficiency Anaemia

18-Apr-2007 11:25 AM Page: 99

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Thrombosis In Device

Ventricular Arrhythmia

Report Source Product Role Manufacturer Route Dose Duration

Zocor PS Merck & Co., Inc ORAL 140 DAY

Polyethylene Glycol

4000 SS ORAL

Sodium Phosphate,

Dibasic And Sodium

Phosphate, Monobasic SS ORAL 2 DAY

Bisoprolol Fumarate SS ORAL

Aspirin Lysine C ORAL

Date:06/20/05ISR Number: 4695090-5Report Type:Expedited (15-DaCompany Report #FR-MERCK-0506FRA00047 Age:93 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Acute Myocardial Zocor PS Merck & Co., Inc ORAL 140 DAY

Life-Threatening Infarction Polyethylene Glycol

Hospitalization - Cardio-Respiratory Arrest 4000 SS ORAL

Initial or Prolonged Cardiogenic Shock Sodium Phosphate,

Dehydration Dibasic And Sodium

Diarrhoea Phosphate, Monobasic SS ORAL 2 DAY

Hypernatraemia Bisoprolol Fumarate SS ORAL

Hypokalaemia Aspirin Lysine C ORAL

Thrombosis In Device

Ventricular Arrhythmia

Date:06/21/05ISR Number: 4696036-6Report Type:Expedited (15-DaCompany Report #FR-GLAXOSMITHKLINE-B0384932A Age:4 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Lung Disorder Ventoline PS Glaxosmithkline UNKNOWN

Initial or Prolonged Thrombocytopenia Clamoxyl SS Glaxosmithkline UNKNOWN 10 DAY

Aspegic SS UNKNOWN

Lasilix SS Glaxosmithkline UNKNOWN

Ciflox SS UNKNOWN 10 DAY

Somatropin SS UNKNOWN 4 MON

Singulair SS UNKNOWN

Forlax SS UNKNOWN

Lopril SS Glaxosmithkline UNKNOWN

Atrovent SS Glaxosmithkline UNKNOWN

Pulmicort SS UNKNOWN

Motilium SS UNKNOWN

Date:06/23/05ISR Number: 4698829-8Report Type:Expedited (15-DaCompany Report #002#3#2005-00179 Age:12 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Abscess Health Glycolax

Initial or Prolonged Constipation Professional (Polyethylene Glycol

Drug Ineffective Other 3350) PS OTHER 1 IN 1 D,

Drug Prescribing Error OTHER

Ewing'S Sarcoma

Gastrointestinal Disorder

Leukopenia

Pharmaceutical Product

Complaint

18-Apr-2007 11:25 AM Page: 100

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:06/27/05ISR Number: 4701905-4Report Type:Expedited (15-DaCompany Report #050067 Age:52 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Required Dehydration Health Halflytely And

Intervention to Dizziness Professional Bisacodyl Tablets

Prevent Permanent Hypovolaemia Other Bowel Prep Kit PS ORAL 20 MG/2L, 1X,

Impairment/Damage PO

Date:06/28/05ISR Number: 4703572-2Report Type:Expedited (15-DaCompany Report #050070 Age:78 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Abdominal Distension Consumer Halflytely And

Initial or Prolonged Abdominal Pain Bisacodyl PS ORAL 20 MG/2L, 1X;

Diarrhoea PO

Faeces Discoloured Diovan C

Haematochezia Fosamax C

Hypersensitivity Pravachol C

Synthroid C

Date:06/29/05ISR Number: 4705314-3Report Type:Expedited (15-DaCompany Report #002#3#2005-00179 Age:12 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Abscess Health Glycolax

Initial or Prolonged Abscess Intestinal Professional (Polythylene Glycol

Constipation Other 3350) PS 1 IN 1 D,

Drug Administration Error OTHER

Drug Ineffective Chemotherapy C

Gastrointestinal Disorder

Incorrect Drug Dosage

Form Administered

Leukopenia

Medical Device Site

Reaction

Medication Error

Post Procedural

Complication

Sepsis

Vomiting

Date:06/29/05ISR Number: 4705315-5Report Type:Expedited (15-DaCompany Report #002#4#2005-00194 Age:78 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Arthritis Consumer Glycolax

Initial or Prolonged Crohn'S Disease Other (Polyethylene Glycol

Diarrhoea 3350) PS ORAL 17 G, 1 IN 1

Infection Parasitic D, ORAL

Pain Valsartan C

Rash Nifedipine C

Urticaria Levothyroxine C

Weight Decreased

18-Apr-2007 11:25 AM Page: 101

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:07/06/05ISR Number: 4708600-6Report Type:Expedited (15-DaCompany Report #FRWYE749916JUN05 Age:93 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Acute Myocardial Foreign Soprol (Bisoprolol,

Infarction Health Tablet, 0) PS ORAL 10 MG 1X PER

Cardio-Respiratory Arrest Professional 1 DAY ORAL

Cardiogenic Shock Other Fleet Phospho-Soda

Dehydration (Sodium Phosphate

Diarrhoea Dibasic/Sodium

Hypernatraemia Phosphate Monobasic,

Hypokalaemia , 0) SS ORAL ORAL 2 DAY

Thrombosis In Device Forlax (Macrogol, ,

Ventricular Arrhythmia 0) SS ORAL 2 DOSE 1X PER

1 DAY ORAL

Zocor (Simvastatin,

, 0) SS ORAL 20 MG 1X PER

1 DAY ORAL 139 DAY

Date:07/13/05ISR Number: 4714769-XReport Type:Expedited (15-DaCompany Report #050045 Age:61 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Hypokalaemia Health Halflytely And

Initial or Prolonged Hypomagnesaemia Professional Bisacodyl PS ORAL 20 MG/2L, 1X,

Hyponatraemia PO

Hypotension Prevacid C

Loss Of Consciousness Cozaar C

Syncope Xanax C

White Blood Cell Count Estrace C

Increased Calcium C

Effexor C

Date:07/19/05ISR Number: 4720389-3Report Type:Expedited (15-DaCompany Report #050079 Age:51 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Anaphylactic Reaction Consumer Halflytely And

Initial or Prolonged Aphonia Bisacodyl Tablets

Dysphonia Bowel Prep Kit PS ORAL 20 MG/2L, 1X,

Throat Tightness PO

... SS

High Blood Pressure

Medications C

Date:07/21/05ISR Number: 4720788-XReport Type:Expedited (15-DaCompany Report #JP-ABBOTT-01P-087-0107353-00 Age: Gender:Male I/FU:F

Outcome PT

Hospitalization - Acute Abdomen

Initial or Prolonged Affect Lability

Other Anaemia

Blood Creatine

Phosphokinase Increased

Depression

Diarrhoea

Dry Skin

Gastrointestinal

Haemorrhage

18-Apr-2007 11:25 AM Page: 102

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Insomnia

Liver Disorder

Nausea Report Source Product Role Manufacturer Route Dose Duration

Pyrexia Norvir Soft Gelatin

White Blood Cell Count Capsules PS ORAL

Decreased Norvir Soft Gelatin

Capsules SS ORAL

Norvir Soft Gelatin

Capsules SS ORAL

Norvir Soft Gelatin

Capsules SS ORAL

Kaletra Soft Gelatin

Capsules SS ORAL 69 DAY

Didanosine SS ORAL

Didanosine SS

Stavudine SS ORAL

Indinavir SS ORAL

Saquinavir SS ORAL

Lamivudine SS ORAL

Abacavir SS ORAL 71 DAY

Amprenavir SS ORAL 1 DAY

Efavirenz SS ORAL 68 DAY

Atazanavir SS ORAL

Ribavirin SS ORAL 15 DAY

Prg Interferon SS 15 DAY

Octocog Alfa C 35 DAY

Rurioctocog Alfa C 293 DAY

Factor Viii

(Antihaemophilic

Factor) C

Multivitamins C ORAL

Allopurinol C ORAL 4 YR

Famotidine C ORAL

Lansoprazole C ORAL 23 DAY

Teprenone C ORAL

Spironolactone C ORAL

Zopiclone C ORAL

Date:07/21/05ISR Number: 4724563-1Report Type:Expedited (15-DaCompany Report #211352 Age:63 YR Gender:Male I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Hepatitis B Foreign Rituxan (Rituximab)

Health Conc For Solution

Professional For Infusion PS INTRAVENOUS 570 MG

Other INTRAVENOUS

Methotrexate

(Methotrexate) SS INTRAVENOUS 4860 MG

INTRAVENOUS

Bleomycin (Bleomycin

Sulfate) SS INTRAVENOUS 6.5 MG

18-Apr-2007 11:25 AM Page: 103

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

INTRAVENOUS

Doxorubicin

Hydrochloride(Doxoru

bicin Hydrochloride) SS INTRAVENOUS 73 MG

INTRAVENOUS

Cyclophosphamide

(Cyclophosphamide) SS INTRAVENOUS 1000 MG

INTRAVENOUS

Vincristien

(Vincristine

Sulfate) SS INTRAVENOUS 1.6 MG

INTRAVENOUS

Dexamethasone Sodium

Phosphate

(Dexamethasone

Sodium Phosphate) SS INTRAVENOUS 10 MG

INTRAVENOUS

Human Serum Albumin

(Albumin Human) SS INTRAVENOUS 12.5 G

INTRAVENOUS

Polyethylene Glycol

(Polyethyline

Glycol) SS INTRAVENOUS 5 MG

INTRAVENOUS

Loxonin (Loxoprofen

Sodium) C

Polaramine

(Dexchlorpheniramine

Maleate) C

Date:07/27/05ISR Number: 4727635-0Report Type:Direct Company Report #CTU 254482 Age:59 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Blood Creatine Increased Co-Lyte Soln -Peg PS 1 GALLON ONE

Initial or Prolonged Dehydration TIME

Required Dizziness Albuterol/Ipratrop C

Intervention to Hypotension Clonazepam C

Prevent Permanent Flunisolide C

Impairment/Damage Furosemide C

Gemfibrozil C

Insulin Novolin C

Lisinopril C

Montelukast Na C

Nitroglycerin C

Omeprazole C

Quetiapine Fumarate C

Sertraline Hcl C

Simvastatin C

Theophylline C

Date:08/03/05ISR Number: 4737933-2Report Type:Expedited (15-DaCompany Report #863#3#2005-00008 Age:68 YR Gender:Female I/FU:I

Outcome PT

Hospitalization - Akinesia

Initial or Prolonged Aortic Valve Incompetence

Atrial Flutter

Dyspnoea

Mitral Valve Incompetence

18-Apr-2007 11:25 AM Page: 104

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Oedema Peripheral

Pericardial Effusion

Tricuspid Valve Report Source Product Role Manufacturer Route Dose Duration

Incompetence Idrolax (Macrogol) PS ORAL 2X 10G DAILY

ORAL

Levodopa

(Benserazide

Hydrochloride,

Levodopa) SS ORAL SEE IMAGE

Pergolide Mesilate

(Pergolide Mesilate) SS 1.5MG 3 IN 1

DAY (S) ) 13 MON

Betaxolol

(Betaxolol) SS ORAL 20 MG 1 IN 1

DAY (S) )

Heptaminol

Hydrochloride

(Heptaminol

Hydrochloride) C

Venlafaxine

Hydrochloride

(Venlafaxine

Hydrochloride) C

Alprazolam

(Alprazolam) C

Lysine Aspirin

(Acetylsalicylate

Lysine) C

Date:08/09/05ISR Number: 4740469-6Report Type:Expedited (15-DaCompany Report #863#3#2005-00010 Age:77 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Cardiac Failure Idrolax (Macrogol) PS ORAL ORAL

Initial or Prolonged Hepatitis Candesartin Cilextil

(Candesartan

Cilexetil) SS (4 MG 1 IN 1

DAY (S)) 2 DAY

Clopidogrel Sulphate

(Clopidogrel

Sulfate) SS (75 MG 1 IN 1

DAY (S)) 30 MON

Metoclopramide

(Metoclopramide) SS ORAL ORAL 7 DAY

Bisoprolol Fumerate

(Bisoprolol

Fumarate) C

Furosemide

(Furosemide) C

Date:08/09/05ISR Number: 4740485-4Report Type:Expedited (15-DaCompany Report #863#3#2005-00011 Age:30 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Neutropenia Idrolax (Macrogol) PS ORAL 1.30 G/DAY,

Initial or Prolonged ORAL 29 DAY

Amitriptyline

Hydrochloride

(Amitriptyline

18-Apr-2007 11:25 AM Page: 105

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Hydrochloride) SS ORAL 20 DROPS

(20MG) DAY,

ORAL 29 DAY

Spasfon

(Phloroglucinol,

Trimethylphlorogluci

nol) SS ORAL 6 TAB/DAY,

ORAL 17 DAY

Bromazepam

(Bromazepam) SS

Date:08/09/05ISR Number: 4743701-8Report Type:Expedited (15-DaCompany Report #863#2#2005-00004 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Anal Fissure Foreign Idrolax (Macrogol) PS ORAL 1.256 G

Initial or Prolonged Gastrointestinal Disorder (64G/L 4 IN 4

Inflammatory Bowel HOUR (S))

Disease ORAL 4 HR

Intestinal Perforation

Procedural Complication

Date:08/11/05ISR Number: 4744532-5Report Type:Expedited (15-DaCompany Report #FR-GDP-0512137 Age:2 MON Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Congenital Anomaly Caesarean Section Foreign Erythrogel PS

Congenital Teratoma Health Benzac (Benzoyl

Cryptorchism Professional Peroxide Gel) SS

Drug Exposure During Surgestone SS

Pregnancy Minolis SS 100 MG QD TL

Teratoma Of Testis Rubozinc SS 15 MG BID TL

Nautamine SS

Transipeg SS

Meteospasmyl SS

Normacol SS

Movicol SS

Titanoreine SS

Cirkan SS

Ginkor Fort SS

Imodium SS Janssen

Ercefuryl SS

Date:08/12/05ISR Number: 4743767-5Report Type:Expedited (15-DaCompany Report #2005013672 Age:38 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Coma Lamictal PS Glaxosmithkline ORAL 1 DAY

Initial or Prolonged Suicide Attempt Buscopan SS ORAL 1 DAY

Vomiting Dolormin Extra SS Glaxosmithkline ORAL 400MG Unknown 1 DAY

Doxepine SS ORAL 1 DAY

Movicol SS ORAL 1 DAY

Novaminsulfon SS ORAL 1 DAY

Pantozol SS ORAL 1 DAY

Paracodin N SS Glaxosmithkline ORAL 10MGG Unknown 1 DAY

Pinimenthol SS ORAL 1 DAY

Seroquel SS ORAL 300MG Unknown 1 DAY

Silomat SS ORAL 1 DAY

Simvastatin SS ORAL 1 DAY

18-Apr-2007 11:25 AM Page: 106

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Vomacur SS ORAL 50MG Unknown 1 DAY

Date:08/17/05ISR Number: 4747991-7Report Type:Direct Company Report #CTU 256411 Age: Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Abdominal Pain Glycolax PS ORAL FREQUENCY 2

Pharmaceutical Product DOSES 8.5 OZ

Complaint PER 4-8 C'S

WATER ORALLY

Date:08/17/05ISR Number: 4748604-0Report Type:Expedited (15-DaCompany Report #050094 Age: Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Confusional State Consumer Miralax PS ORAL 17 GRAMS,

Drug Ineffective DAILY, PO 2 WK

Vision Blurred

Date:08/18/05ISR Number: 4748756-2Report Type:Expedited (15-DaCompany Report #002#2#2005-00258 Age:22 MON Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Blood Potassium Increased Consumer Glycolax

Initial or Prolonged Blood Sodium Decreased (Polyethylene Glycol

Decreased Appetite 3350) PS ORAL 8.5G, 1 IN 1

Dehydration D, ORAL;

Diarrhoea 8.5G, 1 IN 1

Electrolyte Imbalance D, ORAL

Eye Swelling Ibuprofen C

Faecaloma

Flushing

Gastroenteritis Viral

Generalised Oedema

Malaise

Protein Total Abnormal

Renal Disorder

Vomiting

Date:08/22/05ISR Number: 4751454-2Report Type:Expedited (15-DaCompany Report #050096 Age:50 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Pharyngeal Oedema Health Golytely PS ORAL 1X, PO

Urticaria Professional

Date:08/22/05ISR Number: 4752064-3Report Type:Periodic Company Report #PHEH2005US07736 Age:63 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Abdominal Pain Consumer Zelnorm (Tegaserod)

Attention Tablet, 6mg PS ORAL 6 MG, QD,

Deficit/Hyperactivity ORAL

Disorder Miralax (Macrogol) SS

Constipation

Drug Ineffective

18-Apr-2007 11:25 AM Page: 107

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:08/25/05ISR Number: 4753757-4Report Type:Expedited (15-DaCompany Report #002#2#2005-00258 Age:22 MON Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Blood Potassium Increased Consumer Glycolax

Initial or Prolonged Blood Sodium Decreased (Polyethylene Glycol

Eye Swelling 3350) PS ORAL 8.5G, 1 IN 1

Faecaloma D, ORAL

Flushing Ibuprofen C

Gastroenteritis Viral

Generalised Oedema

Incorrect Dose

Administered

Malabsorption

Protein Total Abnormal

Renal Disorder

Date:08/25/05ISR Number: 4753758-6Report Type:Expedited (15-DaCompany Report #002#2#2005-00273 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Anaemia Consumer Glycolax

Initial or Prolonged Drug Dose Omission (Polyethylene Glycol

Faeces Discoloured 3350 PS ORAL 17G, 1 IN 1

Infrequent Bowel D, ORAL

Movements Valsartan C

Diovan-Hct C

Amlodipine C

Sertraline-Hydrochlo

ride C

Esomeprazole C

Levothyroxine C

Multivitamin C

Date:08/29/05ISR Number: 4757075-XReport Type:Direct Company Report #CTU 257124 Age:50 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Dysphagia Glycolax 17 Gm PS IN 8 OZ WATER

Dyspnoea BID

Therapeutic Response

Unexpected With Drug

Substitution

Date:08/30/05ISR Number: 4759895-4Report Type:Direct Company Report #CTU 257189 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Drug Ineffective Glycolax PS 17 GM QD /G

Therapeutic Response TUBE PRN

Unexpected With Drug

Substitution

18-Apr-2007 11:25 AM Page: 108

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:08/31/05ISR Number: 4759394-XReport Type:Expedited (15-DaCompany Report #050098 Age:64 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Colitis Ischaemic Health Halflytely And

Initial or Prolonged Infusion Site Phlebitis Professional Bisacodyl Tablets

Pain Bowel Prep Kit PS ORAL 20MG/2L, 1X,

Venous Thrombosis PO

Nexium C

Crestor C

Primpro C

Niacin C

Date:08/31/05ISR Number: 4759412-9Report Type:Expedited (15-DaCompany Report #050070 Age:78 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Abdominal Distension Consumer Halflytely And

Initial or Prolonged Diarrhoea Haemorrhagic Bisacodyl Tablets

Faeces Discoloured Bowel Prep Kit PS ORAL 20 MG/2L, 1X,

Haematochezia PO

Hypersensitivity Diovan C

Muscle Spasms Fosamax C

Pain Pravachol C

Synthroid C

Date:09/06/05ISR Number: 4762137-7Report Type:Direct Company Report #USP 57307 Age: Gender: I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Drug Dispensing Error Glycolax PS Schwarz Pharma POWDER FOR

Incorrect Dose RECONSTITUTIO

Administered N

Malnutrition Miralax SS Braintree POWDER FOR

Medication Error RECONSTITUTIO

Pharmaceutical Product N

Complaint

Vomiting

Date:09/07/05ISR Number: 4763477-8Report Type:Direct Company Report #CTU 257732 Age: Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Anorexia Glycolax-Polyethylen

Retching eglycol 3350 Kremers

Therapeutic Response Urban PS Kremers Urban 8.5 GRAMS IN

Unexpected With Drug 4OZ FLUID Q

Substitution DAY

Date:09/14/05ISR Number: 4770536-2Report Type:Expedited (15-DaCompany Report #6017035 Age:73 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Erythema Annulare Foreign Levothyrox (Tablet)

Initial or Prolonged Pruritus Health (Levothyroxine

Professional Sodium) PS ORAL ORAL

Other Daflon (Tablet)

(Diosmin) SS ORAL ORAL

18-Apr-2007 11:25 AM Page: 109

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Forlax (Powder For

Oral Solution)

(Macrogol) SS ORAL ORAL

Doliprane

(Paracetamol) C

Arthro-Drainol (Oral

Solution) C

Date:09/15/05ISR Number: 4777507-0Report Type:Expedited (15-DaCompany Report #050108 Age:42 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Arteriovenous Health Halflytely And

Malformation Professional Bisacodyl Tablets

Colitis Ischaemic Bowel Prep Kit PS ORAL 20 MG/2L, 1X,

Colonic Polyp PO

Erythema Aspirin C

Large Intestinal Ulcer Neurontin C

Nausea Vytorin C

Pain Lortab C

Hyzaar C

Clonidine C

Date:09/28/05ISR Number: 4784847-8Report Type:Expedited (15-DaCompany Report #863#3#2005-00013 Age:73 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Erythema Annulare Idrolax (Macrogol) PS ORAL ORAL 1 YR

Initial or Prolonged Pruritus Diosmine,

Hesperidine

(Diosmin,

Hesperidin) SS ORAL ORAL 5 YR

Levothyroxine

(Levothyroxine

Sodium) SS ORAL ORAL 7 YR

Paracetamol

(Paracetamol) SS ORAL ORAL

Arthro Drainol SS ORAL ORAL 10 YR

Date:09/29/05ISR Number: 4782746-9Report Type:Expedited (15-DaCompany Report #PHRM2005FR02555 Age:65 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Biliary Dilatation Lioresal PS Novartis Sector:

Initial or Prolonged Blood Alkaline Pharma ORAL 10 mg, QD 79200MIN

Phosphatase Increased Rivotril SS ORAL 18 mg, QD

Blood Creatinine Forlax SS ORAL 10 g, TID 148 DAY

Increased Xanax C ORAL 79200MIN

Gamma-Glutamyltransferase Skenan C ORAL 100 mg, BID 148 DAY

Increased

Date:09/29/05ISR Number: 4784442-0Report Type:Direct Company Report #CTU 259239 Age:10 MON Gender:Female I/FU:I

Outcome

Required

Intervention to

18-Apr-2007 11:25 AM Page: 110

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Prevent Permanent

Impairment/Damage

PT Report Source Product Role Manufacturer Route Dose Duration

Anaemia Miralax 17 Gm PS ORAL 1 CAPFUL

Asthenia DAILY PO

Dehydration

Failure To Thrive

Family Stress

General Physical Health

Deterioration

Lethargy

Nausea

Neutropenia

Pallor

Pyrexia

Tooth Discolouration

Tooth Hypoplasia

Vomiting

Weight Below Normal

Date:10/07/05ISR Number: 4796349-3Report Type:Expedited (15-DaCompany Report #DEWYE009027SEP05 Age:71 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Life-Threatening Agranulocytosis Health Pipril

Dermatitis Bullous Professional (Piperacillin,

Drug Eruption Other Injection) PS INTRAVENOUS 4 G 3X PER 1

Haemoglobin Decreased DAY;

Hepatitis Toxic INTRAVENOUS,

Lymphocyte Percentage 4 G 3X PER 1

Increased DAY; 2 DAY

White Blood Cell Count Acc (Acetylcysteine,

Decreased , 0) SS

Aciclovir

(Aciclovir, , 0) SS

Actrapid Penfil

(Insulin Human, , 0) SS

Antra (Omeprazole, ,

0) SS

Ass-Ratiopharm

(Acetylsalicylic

Acid, , 0) SS

At-Iii (Antithrombin

Iii, , 0) SS

Beloc Zok

(Metoprolol

Succinate, , 0) SS

Clexane

(Heparin-Fraction,

Sodium Salt, , 0) SS

Clinomel (Amino

Acids/Carbohydrates/

Minerals/Vitamins, ,

0) SS

Combactam (Sulbactam

Sodium , , 0) SS

Delix (Ramipril, ,

0) SS

epam (epam,

, 0) SS

18-Apr-2007 11:25 AM Page: 111

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Digitoxin

(Digitoxin, , 0) SS

Dobutamine

(Dobutamine, , 0) SS

Dormicum (Midazolam

Maleate, , 0) SS

Dynexan (Aluminium

Formate/Arnica

Montana/Chamomile/Sa

lvia/Tetracaine

Hydrochloride, , 0) SS

Ebrantil (Urapidil,

, 0) SS

Erythromycin

(Erythromycin, , 0) SS

Etomidate

(Etomidate, , 0) SS

Falicard (Verapamil

Hydrochloride, , 0) SS

Hydrocortisone

(Hydrocortisone, ,

0) SS

Irenat (Sodium

Perchlorate, , 0) SS

Jonosteril (Calcium

Acetate/Magnesium

Acetate/Potassium

Acetate/Sodium

Acetate/Sodium SS

Lasix (Furosemide, ,

0) SS

Mcp-Ratiopharm

(Metoclopramide

Hydrochloride, , 0) SS

Movicol

(Macrogol/Pottasium

Chloride/Sodium

Bicarbonate/Sodium

Chloride, , 0) SS

Nexium

(Esomeprazole, , 0) SS

Nitroglicerina

(Glyceryl

Trinitrate, , 0) SS

Noradrenaline

(Norephinephrine, ,

0) SS

Norvasc (Amlodipine

Besilate , , 0) SS

Novaminsulfon-Ratiop

harm (Metamizole

Sodium, , 0) SS

Potassium

(Potassium, , 0) SS

Prednisolone

(Prednisolone, , 0) SS

Pyoctanine Bozi

(Boric

Acid/Methylrosanilin

ium Chloride/Zinc

Oxide, , 0) SS

18-Apr-2007 11:25 AM Page: 112

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Rocephin

(Ceftriaxone Sodium,

, 0) SS

Salbutol

(Salbutamol, , 0) SS

Sufenta (Sufentanil

Citrate, , 0) SS

Targocid

(Teicoplanin, , 0) SS

Triclosan

(Triclosan, , 0) SS

Vancomycin

(Vancomycin, , 0) SS

Date:10/17/05ISR Number: 4805218-1Report Type:Expedited (15-DaCompany Report #2005136928 Age:83 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Macular Degeneration Consumer Visine Tears

(Glycerin,

Polyethylene Glycol,

Hydroxypropylmethylc

ellulose) PS OPHTHALMIC 1 DROP PER

EYE 4-5 TIMES

PER DAY,

OPHTHALMIC

Furosemide

(Furosemide) C

Atenolol (Atenolol) C

Irbesartan

(Irbesartan) C

Levothyroxine

(Levothyroxine) C

Amlodipine Besilate

(Amlodipine

Besilate) C

Date:10/27/05ISR Number: 4815411-XReport Type:Expedited (15-DaCompany Report #050120 Age:65 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Colitis Ischaemic Health Halflytely And

Haemorrhage Professional Bisacodyl Tablets

Bowel Prep Kit PS ORAL 20 MG/2L, 1X,

PO

Levothyroxine C

Vytorin C

Lisinopril C

Hydrochlorothiazide C

Aspirin C

Date:10/27/05ISR Number: 4815412-1Report Type:Expedited (15-DaCompany Report #050121 Age:50 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Colitis Ischaemic Health Halflytely And

Initial or Prolonged Post Procedural Professional Bisacodyl Tablets

Haemorrhage Bowel Prep Kit PS ORAL 20 MG/2L, 1X,

18-Apr-2007 11:25 AM Page: 113

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

PO

Celexa C

Xanax C

Naproxen C

Date:10/27/05ISR Number: 4815413-3Report Type:Expedited (15-DaCompany Report #030025 Age:79 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Vomiting Health Golytely PS 4 LITERS NG

Initial or Prolonged Professional

Date:10/31/05ISR Number: 4816317-2Report Type:Expedited (15-DaCompany Report #US-MERCK-0510USA09253 Age:78 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Adverse Event Vioxx PS Merck & Co., Inc ORAL

Hospitalization - Clostridium Colitis Glycolax SS ORAL

Initial or Prolonged Crohn'S Disease Diovan C UNKNOWN

Diarrhoea Nifedical Xl C UNKNOWN

Gastrointestinal Synthroid C ORAL

Infection

Salmonellosis

Sepsis

Weight Decreased

Date:10/31/05ISR Number: 4816731-5Report Type:Direct Company Report #CTU 261797 Age:7 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Life-Threatening Convulsion Miralax 17g PS ORAL 1-2

Hospitalization - Dehydration TABLESPOONS

Initial or Prolonged Developmental THREE TIMES

Disability Coordination Disorder DAILY PO 3 DAY

Required Encopresis

Intervention to Hyponatraemia

Prevent Permanent Lethargy

Impairment/Damage Mental Status Changes

Speech Disorder

Developmental

Therapy Non-Responder

Date:11/01/05ISR Number: 4818679-9Report Type:Expedited (15-DaCompany Report #002#4#2005-00194 Age:78 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Clostridium Colitis Consumer Glycolax

Hospitalization - Crohn'S Disease Other (Polyethylene Glycol

Initial or Prolonged Infection Parasitic 3350) PS ORAL 17G, 1 IN 1

Intestinal Ischaemia D, ORAL

Pain Rofecoxib SS ORAL ORAL

Rash Valsartan C

Salmonellosis Nifedipine C

Sepsis Levothyroxine C

Urticaria Valdecoxib C

Weight Decreased

18-Apr-2007 11:25 AM Page: 114

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:11/03/05ISR Number: 4821587-0Report Type:Direct Company Report #CTU 262372 Age:45 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Drug Effect Decreased Generic Miralax PS 17 GM DAILY

Therapeutic Response

Unexpected With Drug

Substitution

Date:11/14/05ISR Number: 4833642-XReport Type:Expedited (15-DaCompany Report #050134 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Chills Consumer Halflytely And

Dyspnoea Bisacodyl Tablets

Nausea Bowel Prep Kit PS

Vomiting

Date:11/17/05ISR Number: 4832732-5Report Type:Direct Company Report #CTU 263347 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Hyponatraemia Golytely PS ORAL 1 BOTTLE

Initial or Prolonged ONCE PO

Date:11/18/05ISR Number: 4835750-6Report Type:Expedited (15-DaCompany Report #002#2#2005-00339 Age:5 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Blood Ketone Body Consumer Glycolax

Required Increased (Polyethylene Glycol

Intervention to Convulsion 3350) PS ORAL 17G, 1 IN 1

Prevent Permanent Cough D, ORAL

Impairment/Damage Drug Ineffective Cough-Medicine SS ORAL 1 ONCE, ORAL

Irritability

Malaise

Oral Intake Reduced

Pyrexia

Date:11/23/05ISR Number: 4837908-9Report Type:Direct Company Report #CTU 263795 Age:9 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Acute Lymphocytic Miralax PS ORAL 17 GM DAILY

Leukaemia ORAL 7 YR

Date:11/25/05ISR Number: 4840135-2Report Type:Expedited (15-DaCompany Report #2005155270 Age:23 MON Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Accidental Drug Intake By Consumer Advanced Relief

Initial or Prolonged Child Visine (Povidone,

Blood Pressure Decreased Dextran 70,

Lethargy Polyethylene Glycol,

Somnolence Tetryzoline) PS ORAL ORAL

18-Apr-2007 11:25 AM Page: 115

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:12/12/05ISR Number: 4852819-0Report Type:Direct Company Report #CTU 264851 Age: Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Life-Threatening Anaphylactic Reaction Golytely Braintree

Vomiting Laboratories PS Braintree

Laboratories ORAL 4 LITERS

ORDERED. 300

CC TAKEN X1

PO

Date:12/13/05ISR Number: 4854098-7Report Type:Expedited (15-DaCompany Report #050151 Age:88 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Abdominal Distension Consumer Golytely PS ORAL 8OZ/DAILY/PO;

Initial or Prolonged Abdominal Pain 2 - 3 YEARS

Coma High Blood Pressure

Infection Med C

Vomiting Aromasin C

Date:12/14/05ISR Number: 4856241-2Report Type:Direct Company Report #CTU 265037 Age:84 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Therapeutic Response Polyethylene Glycol

Unexpected With Drug 3350 Pwd 527g PS Affordable

Substitution Pharmaceuticals MIX AND DRINK

1 CAPFUL

TWICE A DAY

(DURATION:

APPROX ONE 1 YR

Plavix C

Singulair C

Zocor C

Quinine Sulfate C

Benicar C

Date:12/16/05ISR Number: 4861627-6Report Type:Expedited (15-DaCompany Report #2005165544 Age:88 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Intestinal Obstruction Consumer Aromasin

Initial or Prolonged Loss Of Consciousness (Exemestane) PS ORAL 25 MG (25 MG,

Other Vomiting DAILY, EVERY

DAY), ORAL

Golytely (Macrogol,

Potassium Chloride,

Sodium Bicarbonate,

Sodium SS 8 OZ (DAILY,

EVERY DAY)

Atenolol (Atenolol) SS 37.5 MG (25

MG, TID,

EVERY DAY)

Reglan

(Metoclopramide) SS

18-Apr-2007 11:25 AM Page: 116

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:12/19/05ISR Number: 4862941-0Report Type:Expedited (15-DaCompany Report #050152 Age:62 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Abdominal Pain Consumer Halflytely And

Colitis Ischaemic Health Bisacodyl

Rectal Haemorrhage Professional Tablets Bowel Prep

Kit PS ORAL 20MG/2L, 1X,

PO

Thyroid C

Progesterone C

Actolin C

Date:12/19/05ISR Number: 4862944-6Report Type:Expedited (15-DaCompany Report #050154 Age:63 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Respiratory Arrest Health Halflytely And

Initial or Prolonged Sensation Of Foreign Body Professional Bisacodyl Tablets

Throat Tightness Bowel Prep Kit PS ORAL ABOUT 8 OZ.,

Vomiting 1X, PO

Date:12/22/05ISR Number: 4885400-8Report Type:Periodic Company Report #002#1#2005-00043 Age:30 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Anaphylactic Reaction Health Colyte-With-Flavor-P

Required Professional acks (Orange)

Intervention to (Polyethylene Glycol

Prevent Permanent 3350) PS ORAL 8OU, 2 IN 1

Impairment/Damage D, ORAL

Date:12/28/05ISR Number: 4870116-4Report Type:Expedited (15-DaCompany Report #050158 Age:84 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Diarrhoea Consumer Halflytely And

Malaise Bisocodyl Tablets

Vomiting Bowel Prep Kit PS ORAL 20MG, 1X, PO

Aspirin C

Plavix C

Date:12/29/05ISR Number: 4870906-8Report Type:Expedited (15-DaCompany Report #863#3#2005-00016 Age:75 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Life-Threatening Accidental Overdose Idrolax (Macrogol) PS ORAL ORAL 43 DAY

Coma Fosfomycin

Diarrhoea Trometamol

Electrolyte Imbalance (Fosfomycin

Hyponatraemia Trometamol) SS ORAL 3 G ORAL 1 DAY

Loss Of Consciousness Modopar (Venserazide

Malaise Hydrochloride,

Weight Decreased Levodopa) C

Mebeverine

(Mebeverine) C

Tramadol (Tramadol) C

Troxerutine

18-Apr-2007 11:25 AM Page: 117

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

(Troxerutin) C

Date:12/29/05ISR Number: 4871485-1Report Type:Expedited (15-DaCompany Report #050160 Age: Gender: I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Colitis Ischaemic Health Halflytely And

Haemorrhage Professional Bisacodyl Tablets

Bowel Prep Kit PS UNKNOWN UNKNOWN

Date:01/11/06ISR Number: 4881186-1Report Type:Direct Company Report #CTU 266682 Age: Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Life-Threatening Acute Leukaemia Miralax PS ORAL 17 GM PRN PO 6 YR

Hospitalization -

Initial or Prolonged

Required

Intervention to

Prevent Permanent

Impairment/Damage

Date:01/12/06ISR Number: 4882051-6Report Type:Expedited (15-DaCompany Report #050121 Age:50 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Colitis Ischaemic Health Halflytely And

Initial or Prolonged Haemorrhage Professional Bisacodyl Tablets

Bowel Prep Kit PS ORAL 20 MG/2L, 1X,

PO

Celexa C

Xanax C

Naproxen C

Date:01/12/06ISR Number: 4882052-8Report Type:Expedited (15-DaCompany Report #050120 Age:65 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Colitis Ischaemic Health Halflytely And

Post Procedural Professional Bisacodyl Tablets

Haemorrhage Bowel Prep Kit PS ORAL 20 MG/2L, 1X,

PO

Levothyroxine C

Vytorin C

Lisinopril C

Hydrochlorothiazide C

Aspirin C

Date:01/18/06ISR Number: 4887557-1Report Type:Expedited (15-DaCompany Report #868#4#2006-00001 Age:67 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Grand Mal Convulsion Foreign Colyte-For-Oral-Solu

Required Health tion (Polyethylene

Intervention to Professional Glycol 3350) PS ORAL 41, LONCE,

Prevent Permanent Other ORAL

Impairment/Damage Clopidogrel C

18-Apr-2007 11:25 AM Page: 118

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Atorvastatin-Calcium C

Hydrochlorothiazide C

Ramipril C

Atenolol C

Nifedipine C

Folic Acid C

Date:01/20/06ISR Number: 4889742-1Report Type:Expedited (15-DaCompany Report #050089 Age:61 YR Gender:Male I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Blood Potassium Decreased Consumer Golytely PS ORAL 4 L, 1X, PO

Initial or Prolonged Supraventricular Aspirin C

Tachycardia Triamterene C

Tachycardia Paroxysmal Felodipine C

Atenolol C

Verapamil C

Lisinopril C

Metformin C

Allopurinol C

Ibuprofen C

Glyburide C

Rosiglitazone C

Hydrochlorothiazide

With Triamterene C

Date:01/30/06ISR Number: 4897574-3Report Type:Direct Company Report #CTU 268027 Age: Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Disability Headache Golytely PS 2 GALLONS

Memory Impairment PRIOR TO

COLONOSCOPY

Date:01/31/06ISR Number: 4900122-2Report Type:Expedited (15-DaCompany Report #060008 Age:51 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Required Dizziness Consumer Halflytely And

Intervention to Hyperhidrosis Bisacodyl Tablets

Prevent Permanent Muscle Spasms Bowel Prep Kit PS ORAL 20 MG, 1X ,

Impairment/Damage PO

Acyclovir C

Miralax C

Date:02/10/06ISR Number: 4912986-7Report Type:Expedited (15-DaCompany Report #060012 Age:24 MON Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Anion Gap Increased Health Miralax PS ORAL 1/4 CAPFUL,

Initial or Prolonged Blood Sodium Decreased Professional DAILY, PO

Dehydration

Hyperphosphataemia

Pco2 Decreased

18-Apr-2007 11:25 AM Page: 119

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:02/22/06ISR Number: 4921432-9Report Type:Direct Company Report #CTU 270309 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Drug Ineffective Miralax Powder PS 2 TBSP 8OZ

H20 DAILY

Date:02/22/06ISR Number: 4924771-0Report Type:Expedited (15-DaCompany Report #050154 Age:63 YR Gender:Male I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Anaphylactic Reaction Health Halflytely And

Initial or Prolonged Angioneurotic Oedema Professional Biscodyl PS ORAL 16 OZ., 1X,

Respiratory Arrest PO

Sensation Of Foreign Body Lisinopril C

Vomiting Projectile Lipitor C

Date:02/22/06ISR Number: 4927750-2Report Type:Expedited (15-DaCompany Report #2006020592 Age:79 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Cerebrovascular Accident Consumer Visine Pure Tears

Initial or Prolonged (Glycerin,

Polyethylene Glycol,

Hydroxypropylmethylc

ellulose) PS OPHTHALMIC 1-2 DROPS

EACH EYE ONCE

DAILY AS

NEEDED,

OPHTHALMIC

Atorvastatin

(Atorvastatin) C

Bumetanide

(Bumetanide) C

Date:03/01/06ISR Number: 4932591-6Report Type:Expedited (15-DaCompany Report #863#3#2006-00003 Age:84 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Confusional State Foreign Idrolax (Macrogol) PS ORAL 10 G 1 IN 1

Initial or Prolonged Cytolytic Hepatitis Health DAY(S)

Myoclonus Professional Warfarin (Warfarin

Renal Failure Acute Other Sodium) SS ORAL

Somnolence Allopurinol

(Allopurinol) SS ORAL

Omeprazole

(Omeprazole) SS ORAL

Piperacillin +

Tazobactam

(Piperacillin

Sodium, Tazobactam

Sodium) SS INTRAVENOUS 2 DAY

Paroxetine

(Paroxetine

Hydrochloride) SS ORAL

Salbutamol

(Salbutamol) SS RESPIRATORY

(INHALATION)

Ipratropium

18-Apr-2007 11:25 AM Page: 120

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

(Ipratropium

Bromide) SS RESPIRATORY

(INHALATION)

Digoxin (Digoxin) SS

Fludrocortisone

(Fludrocortisone) SS

Buflomedil

(Buflomedil

Hydrochloride) SS

Paracetamol

(Paracetamol) SS

Levofloxacin C

Augmentin

(Amoxicillin

Trihydrate,

Clavulanate

Potassium) C

Date:03/01/06ISR Number: 4932593-XReport Type:Expedited (15-DaCompany Report #863#3#2005-00013 Age:73 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Erythema Annulare Foreign Idrolax (Macrogol) PS ORAL 1 YR

Initial or Prolonged Pruritus Health Diosmine,

Professional Hesperidine

Other (Disomin,

Hesperidin) SS ORAL 5 YR

Levothyroxine

(Levothyroxine

Sodium) SS ORAL 7 YR

Paracetamol

(Paracetamol) SS ORAL

Arthro Drainol SS ORAL 10 YR

Date:03/08/06ISR Number: 4941794-6Report Type:Expedited (15-DaCompany Report #050108 Age:42 YR Gender:Male I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Arteriovenous Health Halflytely And

Malformation Professional Bisacodyl Tablets

Colitis Ischaemic Bowel Prep Kit PS ORAL 20 MG/2L, 1X,

Colon Adenoma PO

Colonic Polyp Aspirin C

Haemorrhoids Neutontin C

Hypoxia Vytorin C

Nausea Lortab C

Pain Hyzaar C

Clonidine C

Date:03/08/06ISR Number: 4941817-4Report Type:Expedited (15-DaCompany Report #050047 Age:66 YR Gender:Male I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Colitis Ischaemic Health Halflytely And

Initial or Prolonged Large Intestinal Professional Bisacodyl Tablets

Haemorrhage Bowel Prep Kit PS ORAL 20 MG/2L, 1X,

PO

Protonix C

Metamucil C

18-Apr-2007 11:25 AM Page: 121

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Diovan C

Zetia C

Aspirin C

Date:03/09/06ISR Number: 4939192-4Report Type:Direct Company Report #CTU 271669 Age:3.5 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Communication Disorder Miralax PS Affordable

Condition Aggravated Pharmaceuticals, Llc ORAL 1/2 CAP

Constipation DAILY PO 2 DAY

Drug Ineffective

Flatulence

Insomnia

Psychomotor Hyperactivity

Date:03/10/06ISR Number: 4948242-0Report Type:Expedited (15-DaCompany Report #863#3#2006-00004 Age:43 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Life-Threatening Anaphylactic Shock Idrolax (Macrogol) PS ORAL 10 G 1 DAY

Norfloxacin

(Norfloxacin) SS ORAL 800 MG 4 DAY

Ofloxacin C

Acebutolol

(Acebutolol

Hydrochloride) C

Acetylsalicylate

Lysine C

Pravastatin

(Pravastatin Sodium) C

Esomeprazole C

Heparin C

Alprazolam C

Perindopril C

Date:03/13/06ISR Number: 4946425-7Report Type:Expedited (15-DaCompany Report #060026 Age:44 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Anaphylactic Reaction Health Halflytely And

Initial or Prolonged Professional Bisacodyl Tablets

Bowel Prep Kit PS ORAL 20MG/2-8OZ,

1X, PO

Lisonopril C

Nexium C

Lipitor C

Date:03/13/06ISR Number: 4946506-8Report Type:Expedited (15-DaCompany Report #060023 Age:59 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Colitis Health Halflytely And

Initial or Prolonged Gastrointestinal Disorder Professional Bisacodyl Tablets

Muscle Spasms Bowel Prep Kit PS ORAL 20MG/2L, 1X,

PO

18-Apr-2007 11:25 AM Page: 122

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:03/17/06ISR Number: 4951349-5Report Type:Expedited (15-DaCompany Report #050152 Age:62 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Colitis Ischaemic Consumer Halflytely And

Rectal Haemorrhage Bisacodyl Tablets

Bowel Prep Kit PS ORAL 20MG/2L, 1X,

PO

Thyroid C

Progresterone C

Actolin C

Date:03/20/06ISR Number: 4952622-7Report Type:Expedited (15-DaCompany Report #060031 Age:31 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Acute Respiratory Health Golytely PS

Initial or Prolonged Distress Syndrome Professional

Aspiration

Blood Pressure Decreased

General Physical Health

Deterioration

Iatrogenic Injury

Incorrect Route Of Drug

Administration

Medication Error

Pneumonia

Wrong Technique In Drug

Usage Process

Date:03/23/06ISR Number: 4956821-XReport Type:Expedited (15-DaCompany Report #S06-FRA-00829-01 Age:85 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Myocardial Infarction Foreign Ebixa (Memantine) PS ORAL 5 MG QD PO

Pain Health Trileptal SS ORAL 300 MG BID PO

Professional Seretide SS RESPIRATORY

Other (INHALATION) 500 MCG BID

IN

Vitamin B12 SS INTRAMUSCULAR 1 QMON IM

Tetavax (Tetanus

Antitoxin) SS SUBCUTANEOUS 1 ONCE SC

Movicol SS

Date:03/24/06ISR Number: 4959808-6Report Type:Expedited (15-DaCompany Report #2005026888 Age:44 YR Gender:Female I/FU:I

Outcome PT

Life-Threatening Abdominal Distension

Hospitalization - Abdominal Pain

Initial or Prolonged Aspartate

Aminotransferase

Increased

Blood Bilirubin Increased

Blood Calcium Increased

Carbon Dioxide Decreased

Cardiac Failure

Congestive

Dehydration

18-Apr-2007 11:25 AM Page: 123

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Hypertension

Myocardial Ischaemia

Neutrophil Count Report Source Product Role Manufacturer Route Dose Duration

Increased Study Sutent (Sunitinib

Platelet Count Decreased Health Malate) PS ORAL 50 MG (50 MG,

Ventricular Hypokinesia Professional 1 IN 1 D),

ORAL

Lactulose

(Lactulose) SS

Miralax (Macrogol) SS

Date:03/30/06ISR Number: 4963461-5Report Type:Expedited (15-DaCompany Report #863#1#2006-00002 Age:53 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Face Oedema Health Idrolax (Macrogol) PS ORAL (10 G 1 IN 1

Oedema Professional DAY(S)), ORAL 11 DAY

Peritoneal Effusion

Pleural Effusion

Skin Oedema

Weight Increased

Date:04/04/06ISR Number: 4967352-5Report Type:Expedited (15-DaCompany Report #863#3#2006-00005 Age:33 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Life-Threatening Cardio-Respiratory Idrolax (Macrogol) PS ORAL 1.2 SACHETS

Distress DAILY

Megacolon Tropatepine

Pneumatosis Hydrochloride SS ORAL

Pneumonia Aspiration Levomepromazine SS INTRAMUSCULAR

Shock Flupentixol

(Flupentixol

Dihydrochloride) SS ORAL 120 DF

Valpromide C

Alprazolam C

Normacol (Frangula

Extract, Sterculia) C

Date:04/05/06ISR Number: 4969336-XReport Type:Expedited (15-DaCompany Report #002#2#2006-00084 Age:61 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Diverticulitis Consumer Glycolax

Dizziness (Polyethylene Glycol

Fall 3350) PS ORAL IN 1 ONCE,

Head Injury ORAL

Loss Of Consciousness Simvastatin C

Nausea Hydrochlorothiazide C

Tooth Fracture

Wound Haemorrhage

18-Apr-2007 11:25 AM Page: 124

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:04/07/06ISR Number: 4971807-7Report Type:Expedited (15-DaCompany Report #060037 Age: Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Colitis Ischaemic Health Halflytely And

Initial or Prolonged Muscle Spasms Professional Bisacodyl PS ORAL 20MG/2L, 1X,

Rectal Haemorrhage PO

Date:04/12/06ISR Number: 4977001-8Report Type:Expedited (15-DaCompany Report #060040 Age:33 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Dysphagia Health Nulytely PS ORAL 1 GLASS, 1X,

Swollen Tongue Professional PO

Atenolol C

Date:04/17/06ISR Number: 4978854-XReport Type:Expedited (15-DaCompany Report #211352 Age:63 YR Gender:Male I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Death Blood Pressure Decreased Foreign Rituxan (Rituximab)

Coma Hepatic Health Conc For Solution

Hepatitis B Professional For Infusion PS INTRAVENOUS 570 MG,

Hepatitis Fulminant Other INTRAVENOUS

Platelet Count Decreased Methotrexate

Pneumonia (Methotrexate) SS INTRAVENOUS 4860 MG,

INTRAVENOUS

Bleomycin (Bleomycin

Sulfate) SS INTRAVENOUS 6.5 MG,

INTRAVENOUS

Doxorubicin

Hydrochloride

(Doxorubicin

Hydrochloride) SS INTRAVENOUS 73 MG,

INTRAVENOUS

Cyclophosphamide

(Cyclophosphamide) SS INTRAVENOUS 1000 MG,

INTRAVENOUS

Vincristine

(Vincristine

Sulfate) SS INTRAVENOUS 1.6 MG,

INTRAVENOUS

Dexamethasone Sodium

Phosphate

(Dexamethasone

Sodium Phosphate) SS INTRAVENOUS 10 MG,

INTRAVENOUS

Human Serum Albumin

(Albumin Human) SS INTRAVENOUS 12.5 MG,

INTRAVENOUS

Polyethylene Glycol

(Polyethylene

Glycol) SS INTRAVENOUS 5 MG,

INTRAVENOUS

Loxonin (Loxoprofen

Sodium) C

Polaramine

(Dexchlorpheniramine

Maleate) C

18-Apr-2007 11:25 AM Page: 125

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:04/25/06ISR Number: 4989011-5Report Type:Expedited (15-DaCompany Report #S06-USA-01506-01 Age:59 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Constipation Consumer Armour Thyroid

Drug Interaction (Thyroid) PS ORAL 120 MG QD PO

Hyperthyroidism Armour Thyroid

Mania (Thyroid) SS ORAL 120 MG QD PO

Thyroid Function Test Glycolax

Abnormal (Polyethylene

Glycol) SS

Vitamin C C

Magnesium C

Date:04/26/06ISR Number: 5026389-0Report Type:Periodic Company Report #2006002810 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Asthenia Consumer Lyrica (Pregabalin) PS

Diarrhoea Polyethylene Glycol

Drug Interaction (Polyethylene

Oedema Peripheral Glycol) SS

Actos (Pioglitazone) SS

Date:05/01/06ISR Number: 4989705-1Report Type:Expedited (15-DaCompany Report #060053 Age:66 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Colitis Ischaemic Health Halflytely And

Lipoma Professional Bisacodyl Tablets

Bowel Prep Kit PS ORAL 20 MG/2L, 1X,

PO

Date:05/02/06ISR Number: 4992219-6Report Type:Expedited (15-DaCompany Report #060060 Age:69 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Blood Potassium Decreased Consumer Halflytely And

Initial or Prolonged Blood Pressure Increased Bisacodyl Tablets

Chest Pain Bowel Prep Kit PS ORAL 20 MG, 1/3

Dizziness SOLN; 1X, PO

Vomiting Heart Medication C

Blood Pressure Pill C

Potassium Pills C

Date:05/02/06ISR Number: 4992228-7Report Type:Expedited (15-DaCompany Report #050160 Age: Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Colitis Ischaemic Health Halflytely And

Disease Recurrence Professional Bisacodyl Tablets

Diverticulitis Bowel Prep Kit PS

Haemorrhage

Pain

18-Apr-2007 11:25 AM Page: 126

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:05/03/06ISR Number: 4993517-2Report Type:Direct Company Report #CTU 275740 Age:22 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Drug Ineffective Miralax PS

Therapeutic Response

Unexpected With Drug

Substitution

Date:05/05/06ISR Number: 4997150-8Report Type:Direct Company Report #CTU 275925 Age:54 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Pharmaceutical Product Miralax Powder PS Braintree USED BY MOUTH

Complaint AS DIRECTED

Poor Quality Drug

Administered

Stomatitis

Date:05/08/06ISR Number: 4997118-1Report Type:Direct Company Report #CTU 275958 Age:51 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Dysgeusia Polyethylene Bi 3350

Pharmaceutical Product Pwd 527 Gl

Complaint Affordable Pharm PS Affordable Pharm ORAL MIX ONE

CAPFUL (17

GRAMS/1

HEAPING

TABLESPOONFUL 1 YR

Date:05/09/06ISR Number: 4998789-6Report Type:Expedited (15-DaCompany Report #060060 Age:69 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Abdominal Pain Upper Consumer Halflytely And

Initial or Prolonged Asthenia Bisacodyl Tablets

Blood Potassium Decreased Bowel Prep Kit PS ORAL 20 MG, 1/3

Blood Pressure Increased SOLN; 1X, PO

Chest Pain Heart Medication C

Dizziness Blood Pressure Pill C

Dyspnoea Potassium Pills C

Feeling Abnormal

Heart Rate Irregular

Nausea

Vomiting

Date:05/10/06ISR Number: 5002579-8Report Type:Expedited (15-DaCompany Report #HQWYE038428APR06 Age:39 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Drug Exposure During Foreign Pantozol

Pregnancy Health (Pantoprazole,

Professional Tablet, Delayed

Other Release) PS ORAL 20 MG 1X PER

1 DAY ORAL 40 DAY

Lecicarbon

(Lecithin/Sodium

18-Apr-2007 11:25 AM Page: 127

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Bicarbonate/Sodium

Phosphate Monobasic) SS RECTAL 1 DOSAGE FORM

1X PER 1 DAY

RECTAL 4 DAY

Magaldrate

(Magaldrate) SS ORAL 800 MG 1X PER

1 DAY ORAL

Movicol

(Macrogol/Potassium

Chloride/Sodim

Bicarbonate/Sodium

Chloride) SS ORAL 1 DOSAGE FORM

1X PER 1 DAY

ORAL 7 DAY

Neo Citran (Ascorbic

Acid/Paracetamol/Phe

niramine

Maleate/Phenylephrin

e) SS ORAL 1 DOSAGE FORM

1X PER 1 DAY

ORAL 1 DAY

Transipeg (Macrogol) SS ORAL 1 DOSAGE FORM

2X PER 1 DAY

ORAL 4 DAY

Date:05/12/06ISR Number: 5002891-2Report Type:Expedited (15-DaCompany Report #060076 Age:81 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Blood Pressure Decreased Consumer Halflytely And

Initial or Prolonged Cold Sweat Bisacodyl Tablets

Heart Rate Decreased Bowel Prep Kit PS ORAL 20 MG, 1X, PO

Loss Of Consciousness Protonix C

Muscle Spasms

Date:05/17/06ISR Number: 5006918-3Report Type:Expedited (15-DaCompany Report #863#2#2006-00006 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Disability Arthralgia Idrolax (Macrogol) PS ORAL ORAL

Feeling Hot

Hypotension

Muscle Spasms

Nausea

Pain In Extremity

Date:05/18/06ISR Number: 5008714-XReport Type:Expedited (15-DaCompany Report #2006002810 Age:78 YR Gender:Female I/FU:I

Outcome PT

Hospitalization - Asthenia

Initial or Prolonged Cataract

Other Diarrhoea

Drug Interaction

Fatigue

Hypotension

Impaired Healing

Ingrowing Nail

Lethargy

18-Apr-2007 11:25 AM Page: 128

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Loss Of Consciousness

Oedema Peripheral

Overdose Report Source Product Role Manufacturer Route Dose Duration

Pain In Extremity Consumer Lyrica (Pregabalin) PS

Therapy Regimen Changed Polyethylene Glycol

Vision Blurred (Polyethylene

Glycol) SS

Actos (Pioglitazone) SS

Oxycontin (Oxycodone

Hydrochloride) SS

All Other

Therapeutic Products

(All Other

Therapeutic

Products) SS

Toprol (Metoprolol) C

Mavik (Trandolapril) C

Date:05/24/06ISR Number: 5012179-1Report Type:Expedited (15-DaCompany Report #060083 Age:79 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Abdominal Pain Consumer Halflytely And

Initial or Prolonged Dyspnoea Bisacodyl Tablets

Flushing Bowel Prep Kit PS ORAL 20 MG, 1X,

Gastrointestinal Disorder PO, 6 WEEKS

Incoherent AGO

Rectal Haemorrhage Hydrochlorothiazide C

Synthroid C

Lisinopril C

Date:05/30/06ISR Number: 5018667-6Report Type:Expedited (15-DaCompany Report #S06-USA-01506-01 Age:59 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Constipation Consumer Armour Thyroid

Drug Interaction (Thyroid) PS ORAL 120 MG QD PO

Hyperthyroidism Armour Thyroid

Mania (Thyroid) SS ORAL 120 MG QD PO

Glycolax

(Polyethylene

Glycol) SS

Vitamin C C

Magnesium C

Date:06/03/06ISR Number: 5043065-9Report Type:Direct Company Report #CTU 279929 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Drug Ineffective Glycolax PS 17 GM DAILY

Therapeutic Response

Unexpected With Drug

Substitution

18-Apr-2007 11:25 AM Page: 129

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:06/06/06ISR Number: 5021014-7Report Type:Direct Company Report #CTU 278276 Age:57 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Dysgeusia Polyethylene Glycol PS Affordable Pharm OPHTHALMIC ONE SCOOP

Infrequent Bowel MIXED WITH

Movements LIQUID BY

Pharmaceutical Product MOUTH DAILY

Complaint

Date:06/08/06ISR Number: 5026763-2Report Type:Expedited (15-DaCompany Report #2006070439 Age:18 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Chemical Burns Of Eye Consumer Advanced Relief

Eye Discharge Visine (Povidone,

Eye Pain Dextran 70,

Eye Swelling Polyethylene Glycol,

Ocular Hyperaemia Tetryzoline) PS OPHTHALMIC 1-2 DROPS

Superficial Injury Of Eye ONCE IN LEFT

EYE,

OPHTHALMIC

Advanced Relief

Visine (Povidone,

Dextran 70,

Polyethylene Glycol,

Tetryzoline) SS

Date:06/19/06ISR Number: 5032067-4Report Type:Expedited (15-DaCompany Report #CHPA2006US05524 Age:49 YR Gender:Female I/FU:I

Outcome PT

Hospitalization - Anal Spasm

Initial or Prolonged Change Of Bowel Habit

Other Cholecystitis

Cholecystitis Infective

Cholelithiasis

Colonic Polyp

Constipation

Drug Ineffective

Duodenitis

Dysgeusia

Dysphagia

Gallbladder Disorder

Gallbladder Polyp

Gastritis Erosive

Gastrointestinal

Haemorrhage

Gastrooesophageal Reflux

Disease

Haemorrhoids

Helicobacter Gastritis

Hiatus Hernia

Intestinal Ischaemia

Intestinal Polyp

Laxative Abuse

Occult Blood Positive

Oesophagitis

Proctalgia

Rectal Haemorrhage

18-Apr-2007 11:25 AM Page: 130

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Reflux Oesophagitis

Swelling

Report Source Product Role Manufacturer Route Dose Duration

Consumer Ex-Lax Unknown (Nch) PS Nch DAILY

Dulcolax

(Nch)(Bisacodyl) SS Nch DAILY

Correctol

"Schering-Plough"(Bi

sacodyl) SS Schering-Plough DAILY

Metamucil(Ispaghula,

Plantago Ovata) SS PRN

Citrical(Calcium

Carbonate) SS ORAL SEE IMAGE

Milk Of

Magnesia(Magnesium

Hydroxide) SS PRN

Mylanta/Usa/(Calcium

Carbonate) SS Usa PRN

Fleet (Sodium

Citrate, Sodium

Lauryl Sulfoacetate)

Suppository SS PRN

Fleet Enema

/00766901/(Sodium

Phosphate, Sodium

Phosphate Monobasic

(Anhydrate)) SS PRN

Cod-Liver

Oil(Cod-Liver Oil) SS PRN

Saline

Laxative(Sodium

Chloride) SS PRN

Epsom

Salts(Magnesium

Sulfate) SS PRN

Docusate(Docusate) SS ONCE DAILY,

Miralax(Macrogol) SS 8 OUNCES,

DAILY

Mobic (Meloxicam) C

Zoloft (Sertraline

Hydrochloride) C

Crestor

(Rosuvastatin

Calcium) C

Lipitor

(Atorvastatin) C

Atenolol C

Xanax (Alprazolam) C

Nexium (Esomeprazole

Magnesium) C

Carafate

(Sucralfate) C

Date:06/19/06ISR Number: 5032188-6Report Type:Expedited (15-DaCompany Report #060099 Age:60 YR Gender:Male I/FU:I

Outcome PT

Arthralgia

Swollen Tongue

Tremor

18-Apr-2007 11:25 AM Page: 131

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Urticaria

Report Source Product Role Manufacturer Route Dose Duration

Health Nulytely PS ORAL 4L, 1X, PO

Professional

Date:06/19/06ISR Number: 5032229-6Report Type:Expedited (15-DaCompany Report #060097 Age:79 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Colitis Ischaemic Health Halflytely And

Haematochezia Professional Bisacodyl Tablets

Bowel Prep Kit PS ORAL 20MG/2L, 1X,

PO

Synthroid C

Norvasc C

Date:06/21/06ISR Number: 5032395-2Report Type:Direct Company Report #CTU 279279 Age:2 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Urticaria Miralax PS ORAL 1 TBSP BID PO

Date:06/22/06ISR Number: 5037512-6Report Type:Expedited (15-DaCompany Report #060031 Age:31 YR Gender:Male I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Acute Respiratory Health Golytely PS

Initial or Prolonged Distress Syndrome Professional

Aspiration Tracheal

Blood Pressure Decreased

Feeding Tube Complication

Incorrect Route Of Drug

Administration

Paraplegia

Pneumonia

Unevaluable Event

Date:06/23/06ISR Number: 5034526-7Report Type:Direct Company Report #CTU 279367 Age:77 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Abdominal Pain Upper Polyethylene Gi 3350

Dysgeusia Pwd 527g PS Affordable

Pharmaceutical Product Pharmaceutical TAKE ONE

Complaint CAPFUL DAILY 6 WK

Date:06/27/06ISR Number: 5041449-6Report Type:Expedited (15-DaCompany Report #060097 Age:79 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Colitis Ischaemic Health Halflytely And

Haemorrhoids Professional Bisacodyl Tablets

Polyp Bowel Prep Kit PS ORAL 20MG/2L, 1X,

PO

Synthroid C

18-Apr-2007 11:25 AM Page: 132

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Norvasc C

Date:07/06/06ISR Number: 5050319-9Report Type:Expedited (15-DaCompany Report #060109 Age:56 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Anaemia Consumer Nulytely PS ORAL APPROX. 2L,

Initial or Prolonged Blood Pressure Decreased 1X, PO

Diarrhoea Protonix C

Loss Of Consciousness Zoloft C

Renal Failure Acute Thyroid Medication C

Vomiting

Date:07/12/06ISR Number: 5053597-5Report Type:Expedited (15-DaCompany Report #863#1#2006-00007 Age:71 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Activated Partial Health Idrolax (Macrogol) PS ORAL ORAL

Thromboplastin Time Professional Phenprocoumon

Prolonged (Phenprocoumon) C

Cerebrovascular Accident Amlodipine Besilate

International Normalised (Amlodipine

Ratio Decreased Besilate) C

Simvastatin

(Simvastatin) C

Date:07/20/06ISR Number: 5061693-1Report Type:Expedited (15-DaCompany Report #863#1#2006-00007 Age:71 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Activated Partial Foreign Idrolax (Macrogol) PS ORAL ORAL

Thromboplastin Time Health Phenprocoumon

Prolonged Professional (Phenprocoumon) C

Cerebrovascular Accident Amlodipine Besilate

Drug Interaction (Amlodipine

International Normalised Besilate) C

Ratio Decreased Simvastatin

(Simvastatin) C

Date:07/24/06ISR Number: 5066857-9Report Type:Expedited (15-DaCompany Report #6017035 Age:73 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Erythema Annulare Foreign Levothyrox (Tablet)

Initial or Prolonged Pruritus Health (Levothyroxine

Professional Sodium) PS ORAL ORAL

Other Daflon (Tablet)

(Diosmin) SS ORAL ORAL

Forlax (Powder For

Oral Solution)

(Macrogol) SS ORAL ORAL

Doliprane

(Paracetamol) C

Arthro-Drainol (Oral

Solution) C

18-Apr-2007 11:25 AM Page: 133

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:07/25/06ISR Number: 5062632-XReport Type:Direct Company Report #CTU 281586 Age: Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Drug Ineffective Miralax PS

Therapeutic Response

Unexpected With Drug

Substitution

Date:07/25/06ISR Number: 5065634-2Report Type:Expedited (15-DaCompany Report #060109 Age:56 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Anaemia Consumer Nulytely PS ORAL APPROX. 2L,

Initial or Prolonged Anxiety 1X; PO

Asthenia Protonix C

Back Pain Zoloft C

Blood Pressure Decreased Thyroid Medication C

Depressed Level Of Levoxyl C

Consciousness Lipitor C

Depression Protonix C

Diarrhoea Zoloft C

Dizziness Vitamins C

Flushing Advil C

Headache

Hyperlipidaemia

Hypothyroidism

Migraine

Palpitations

Post Procedural

Complication

Renal Failure Acute

Renal Tubular Necrosis

Vomiting

Date:07/31/06ISR Number: 5067692-8Report Type:Expedited (15-DaCompany Report #060119 Age:70 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Arrhythmia Consumer Halflytely And

Blood Potassium Decreased Bisacodyl Tablets

Chest Discomfort Bowel Prep Kit PS ORAL 20MG/2L, 1X,

Drug Dose Omission PO

Heart Rate Increased

Nausea

Date:07/31/06ISR Number: 5067744-2Report Type:Expedited (15-DaCompany Report #060119 Age:70 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Arrhythmia Consumer Halflytely And

Blood Potassium Decreased Bisacodyl Tablets

Chest Discomfort Bowel Prep Kit PS ORAL 20MG/2L, 1X,

Dehydration PO

Drug Dose Omission Diltiazem

Heart Rate Increased Hydrochloride C

Nausea

18-Apr-2007 11:25 AM Page: 134

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:08/03/06ISR Number: 5070965-6Report Type:Direct Company Report #CTU 282258 Age:69 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Constipation Polyethylene Gi 3350

Pharmaceutical Product Pwd 527g PS Teva MIX AND DRINK

Complaint 17GM (1

CAPFUL) IN

8OZ OF WATER

DAILY

Activella C

Hydrocodone Bit/Apap C

Effexor Xr C

Hydroxychloroquine C

Lorazepam C

Bellamine-S C

Levoxyl C

Date:08/03/06ISR Number: 5070968-1Report Type:Direct Company Report #CTU 282259 Age:51 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Bowel Movement Polyethylene Gi 3350

Irregularity Pwd 527g PS Teva MIX 1 TO 2

Diarrhoea CAPFULS INTO

Drug Ineffective 8 OUNCES OF

Dysgeusia WATER AS

Flatulence DIRECTED,

Gastrointestinal Disorder Paroxetine C

Pharmaceutical Product

Complaint

Date:08/03/06ISR Number: 5070970-XReport Type:Direct Company Report #CTU 282260 Age:10 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Inappropriate Schedule Of Polyethylene Glycol

Drug Administration 3350 PS 1 CAPFUL (17

Pharmaceutical Product GRAMS) DAILY

Complaint

Date:08/03/06ISR Number: 5070979-6Report Type:Direct Company Report #CTU 282261 Age:69 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Drug Ineffective Polyethylene Glycol

Nausea 3350 Powder PS Teva 1 HEAPING

Pharmaceutical Product TABLESPOONFUL

Complaint IN WATER

Therapeutic Response

Unexpected With Drug

Substitution

18-Apr-2007 11:25 AM Page: 135

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:08/03/06ISR Number: 5071230-3Report Type:Direct Company Report #CTU 282255 Age:50 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Pharmaceutical Product Polyethylene Gi 3350

Complaint Pwd 527q Teva PS MIX AS

DIRECTED AND

DRINK 2

CAPFULS DAILY

Date:08/03/06ISR Number: 5071254-6Report Type:Direct Company Report #CTU 282257 Age:65 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Pharmaceutical Product Polyethylene Glycol

Complaint 3350 Powder Teva PS Teva ORAL 17GM BY MOUTH

DAILY IN

WATER

Date:08/11/06ISR Number: 5081576-0Report Type:Expedited (15-DaCompany Report #060126 Age:11 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Discomfort Consumer Golytely PS 1 LITER, 1X,

Initial or Prolonged Endotracheal Intubation NG

Complication

Restlessness

Vomiting

Wrong Technique In Drug

Usage Process

Date:08/15/06ISR Number: 5082087-9Report Type:Direct Company Report #CTU 282967 Age:50 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Life-Threatening Dyspnoea Polyethylene Glycol PS Teva ORAL PO

Pharmaceutical Product Aciphex C

Complaint Hctz C

Pharyngeal Oedema Trileptal C

Alprazolam C

Ketoprofen C

Copaxone C

Atenolol C

Cymbalta C

Date:08/15/06ISR Number: 5082168-XReport Type:Direct Company Report #CTU 282947 Age:69 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Abdominal Pain Golytely PS ORAL 1 GALLON ONCE

Initial or Prolonged Asthenia PO 1 DAY

International Normalised

Ratio Decreased

Renal Failure Acute

Urinary Tract Infection

18-Apr-2007 11:25 AM Page: 136

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:08/16/06ISR Number: 5085100-8Report Type:Expedited (15-DaCompany Report #863#1#2006-00008 Age:3 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Disability Urticaria Foreign Idrolax (Macrogol) PS ORAL 8 G (10 G 1

Vomiting Health IN 1 DAY (S))

Professional ORAL

Importal (Lactitol) C

Date:08/22/06ISR Number: 5085607-3Report Type:Expedited (15-DaCompany Report #FR-LMS-060114 Age:68 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Diarrhoea Nabumetone PS Glaxosmithkline ORAL 16 DAY

Initial or Prolonged Drug Interaction Macrogol SS ORAL 1Z Per day

Hypercreatininaemia Valsartan SS ORAL 80MG per day

Hypotension Mediveine C

Nephropathy Tramadol C

Renal Failure Hydrocortisone C Glaxosmithkline

Renal Failure Acute

Renal Tubular Necrosis

Date:08/23/06ISR Number: 5087641-6Report Type:Direct Company Report #CTU 283541 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Headache Polyethylene Glycol

Pharmaceutical Product Powder PS 51 GRAMS

Complaint

Throat Irritation

Date:08/23/06ISR Number: 5088139-1Report Type:Direct Company Report #CTU 283639 Age:56 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Diarrhoea Polyethylene Glycol

Dysgeusia 3350 Pwd 527 G -Teva PS Teva MIX AND DRINK

Pharmaceutical Product TWICE A DAY

Complaint AS DIRECTED

Date:08/24/06ISR Number: 5088923-4Report Type:Direct Company Report #CTU 283712 Age:52 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Life-Threatening Blood Sodium Decreased Nulytely PS ORAL STANDARD 1G

Hospitalization - Coma CONTAINER MIX

Initial or Prolonged Convulsion H20 1 GLASS

Other Fatigue EVERY 10MI

Hypotension PO

Loss Of Consciousness

Memory Impairment

Tremor

18-Apr-2007 11:25 AM Page: 137

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:08/25/06ISR Number: 5092120-6Report Type:Expedited (15-DaCompany Report #863#3#2006-00009 Age:69 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Blood Creatinine Idrolax (Macrogol) PS 1 DAY

Initial or Prolonged Increased Nabumetone

Dehydration (Nabumetone) SS ORAL 16 DAY

Diarrhoea Valsartan

Hypovolaemia (Valsartan) SS ORAL 80 MG (80 MG

Renal Failure Acute 1 IN 1

Renal Tubular Necrosis DAY(S))

Hydrocoritsone

(Hydrocortisone) C

Diosmin (Diosmin) C

Tramadol

Hydrochloride

(Tramadol

Hydrochloride) C

Date:08/30/06ISR Number: 5094834-0Report Type:Direct Company Report #CTU 284025 Age:15 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Pharmaceutical Product Polyethylene Gi 3350

Complaint Pwd 527g Teva PS Teva MIX AND DRINK

17GMS TWICE

DAILY

Date:08/30/06ISR Number: 5094835-2Report Type:Direct Company Report #CTU 284026 Age:48 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Gastrointestinal Disorder Polyethylene Gi 3350

Pharmaceutical Product Pwd 527 G Teva PS Teva MIX 17 GRAMS

Complaint (1 CAPFUL) IN

8 OUNCES OF

WATER AND

DRINK AT

Date:09/08/06ISR Number: 5102868-2Report Type:Expedited (15-DaCompany Report #060083 Age:79 YR Gender:Male I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Abdominal Pain Consumer Halflytely And

Initial or Prolonged Colonic Obstruction Biscadoyl Tablets

Dyspnoea Bowel Prep Kit PS ORAL 20 MG, 1X,

Feeling Hot PO; " 6 WEEKS

Flushing AGO "

Gastrointestinal Hydrochlorothiazide C

Infection Synthroid C

Incoherent Lisinopril C

Intestinal Functional

Disorder

Muscle Spasms

Rectal Haemorrhage

18-Apr-2007 11:25 AM Page: 138

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:09/12/06ISR Number: 5105821-8Report Type:Expedited (15-DaCompany Report #2006S1003431 Age:39 YR Gender:Male I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Anticonvulsant Drug Level Health Extended Phenytoin

Initial or Prolonged Decreased Professional Sodium Capsules, Usp

Diarrhoea (100 Mg) PS ORAL SEE IMAGE,

Hypokalaemia ORAL

Malabsorption Golytely SS ORAL PO

Nausea Sertraline

Vomiting Hydrochloride C

Olanzapine C

Date:09/12/06ISR Number: 5107301-2Report Type:Expedited (15-DaCompany Report #HQWYE038428APR06 Age:39 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Abortion Spontaneous Foreign Pantozol

Drug Exposure During Health (Pantoprazole,

Pregnancy Professional Delayed Release) PS ORAL 20 MG 1X PER

Other 1 DAY 40 DAY

Lecicarbon

(Lecithin/Sodium

Bicarbonate/Sodium

Phosphate

Monobasic,) SS RECTAL 1 DOSAGE FROM

1X PER 1 DAY 4 DAY

Magaldrate

(Magaldrate) SS ORAL 800 MG 1X PER

1 DAY

Movicol

(Macrgol/Potassium

Chloride/Sodium

Bicarbonate/Sodium

Chloride,) SS ORAL 1 DOSAGE FROM

1X PER 1 DAY

Neo Citran

(Ascorbic

Acid/Paracetamol/Phe

niramine

Maleate/Phenylephrin SS ORAL 1 DOSAGE FORM

1 X 1 PER DAY 1 DAY

Transipeg (Macrogol) C

Herbal Preparation

(Herbal Preparation) C

Date:09/13/06ISR Number: 5107517-5Report Type:Direct Company Report #CTU 284937 Age:74 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Drug Intolerance Polyethylene Gi 3350

Pharmaceutical Product Pwd 527 Q- Teva PS Teva MIX 1 SCOOP

Complaint (17 GRAMS) IN

8 OZ WATER

AND DRINK

DAILY

18-Apr-2007 11:25 AM Page: 139

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:09/18/06ISR Number: 5106416-2Report Type:Expedited (15-DaCompany Report #PHRM2006FR02510 Age:70 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Creatinine Renal Parlodel PS Novartis Sector:

Initial or Prolonged Clearance Decreased Pharma ORAL 10 mg, QD

Dehydration Lercan SS OTHER 1 DF, QD

Hyperthermia Largactil SS ORAL 3 mg daily

Hypotension Lasilix SS ORAL 1 DF, QD

Malaise Transipeg /Fra/ SS ORAL 2.95 g, QD

Renal Failure Josir SS ORAL 0.4 mg, QD

Depamide C ORAL

Mepronizine C ORAL

Lysanxia C ORAL

Lepticur C ORAL

Sinemet C ORAL

Trospium Chloride C ORAL

Date:09/19/06ISR Number: 5110062-4Report Type:Direct Company Report #CTU 285306 Age: Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Abdominal Pain Trilyte Solution PS ORAL 4000 ML X 1

Vomiting PO

Date:09/20/06ISR Number: 5112071-8Report Type:Direct Company Report #CTU 285353 Age:73 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Pharmaceutical Product Polyethylene Glycol

Complaint 3350 17gm Pckt Teva PS Teva ORAL MIX AND DRINK

Rash 1 PACKET

Therapy Non-Responder DAILY WITH

JUICE

Hydrochlorothiazide C

Temazepam C

Potassium Chloride C

Date:09/20/06ISR Number: 5113362-7Report Type:Expedited (15-DaCompany Report #060154 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Blood Calcium Decreased Health Nulytely PS

Convulsion Professional

Hyponatraemia

Date:09/21/06ISR Number: 5113719-4Report Type:Expedited (15-DaCompany Report #060164 Age:38 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Required Anaphylactic Reaction Health Polyethylene Glycol

Intervention to Professional 3350 Nf Powder For

Prevent Permanent Solution PS

Impairment/Damage

18-Apr-2007 11:25 AM Page: 140

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:09/21/06ISR Number: 5113771-6Report Type:Direct Company Report #CTU 285400 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Diarrhoea Polyethylene Glycol,

Dysgeusia 3350 Affordable

Pharmaceutical Product Pharm PS Affordable Pharm 17 GRAMS

Complaint DAILY 1 YR

Polyethylene Glycol,

3350, Teva Pharm. SS Teva Pharm 17 GRAMS

DAILY

Date:09/22/06ISR Number: 5114798-0Report Type:Expedited (15-DaCompany Report #060163 Age:76 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Clavicle Fracture Consumer Halflytely And

Initial or Prolonged Fall Bisacodyl Tablets

Hyperhidrosis Bowel Prep Kit PS ORAL 20 MG/8 OZ,

Loss Of Consciousness 1X, PO

Nausea Blood Pressure

Syncope Medication C

Tricor C

Date:10/10/06ISR Number: 5125947-2Report Type:Direct Company Report #CTU 286734 Age:56 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Pharmaceutical Product Polyethylene Gi 3350

Complaint Pwd 527 G - Teva PS Teva MIX AND DRINK

17 GMS DAILY

Date:10/10/06ISR Number: 5125948-4Report Type:Direct Company Report #CTU 286736 Age:56 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Feeling Jittery Polyethylene Gi 3350

Pharmaceutical Product Powder Teva PS Teva MIX AND DRINK

Complaint 17 GM DAILY

Tremor

Date:10/10/06ISR Number: 5125966-6Report Type:Direct Company Report #CTU 286738 Age:70 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Pharmaceutical Product Polyethylene Gi 3350

Complaint Pwd 527g; Teva PS Teva MIX AND DRINK

AS DIRECTED 2 YR

Date:10/10/06ISR Number: 5125967-8Report Type:Direct Company Report #CTU 286740 Age:73 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Pharmaceutical Product Polyethylene Gi 3350

Complaint Pwd 527g- Teva PS Teva MIX 1 CAPFUL

(17 GRAMS) IN

WATER AND

18-Apr-2007 11:25 AM Page: 141

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

DRINK TWICE A

DAY CAPFUL (

Date:10/10/06ISR Number: 5125968-XReport Type:Direct Company Report #CTU 286744 Age:55 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Dysgeusia Polyethylene Glycol

Nausea 3350 Powder Teva PS Teva 1 SCOOPFUL

Pharmaceutical Product FOUR TIMES

Complaint DAILY BY

MOUTH 5 YR

Date:10/10/06ISR Number: 5126101-0Report Type:Direct Company Report #CTU 286730 Age:78 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Dysgeusia Polyethylene Gl 3350

Pharmaceutical Product Pwd 527g - Teva PS Teva MIX ONE

Complaint CAPFUL (17

GRAMS) IN

WATER AND

DRINK DAILY

Date:10/10/06ISR Number: 5126102-2Report Type:Direct Company Report #CTU 286731 Age:74 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Drug Ineffective Polyethylene Gl 3350

Pharmaceutical Product Pwd 527g Teva PS Teva MIX AND DRINK

Complaint AS DIRECTED 2 YR

Date:10/10/06ISR Number: 5126103-4Report Type:Direct Company Report #CTU 286733 Age:12 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Dysgeusia Polyethylene Gl 3350

Pharmaceutical Product Pwd 527g - Teva PS Teva MIX 17 GRAMS

Complaint ( 1 CAPFUL)

IN 6 OUNCES

FLUID AND

DRINK DAILY

Date:10/11/06ISR Number: 5128350-4Report Type:Expedited (15-DaCompany Report #060164 Age:38 YR Gender:Male I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Required Anaphylactic Reaction Health Polyethylene Glycol

Intervention to Professional 3350, Nf Powder For

Prevent Permanent Solution PS

Impairment/Damage

18-Apr-2007 11:25 AM Page: 142

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:10/16/06ISR Number: 5129099-4Report Type:Direct Company Report #CTU 287177 Age:62 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Disability Asthenia Trilyte Peg3350

Blood Pressure Abnormal Schwarz PS Schwarz ORAL 8 OZ UNTIL 64

Chest Pain IS CONSUMED

Electrolyte Imbalance 10 - 15

Erythema MINUTES PO

Feeling Hot

Pulse Abnormal

Syncope

Tremor

Date:10/17/06ISR Number: 5131229-5Report Type:Direct Company Report #CTU 287230 Age:62 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Required Cataract Systane Lubricant

Intervention to Vision Blurred Eye Drops Alcon

Prevent Permanent Visual Disturbance Laboratories, Inc. PS Alcon Laboratories,

Impairment/Damage Inc. OTHER ONE DROP 7-8

TIMES/DAY

OTHER

Date:10/17/06ISR Number: 5132932-3Report Type:Expedited (15-DaCompany Report #863#3#2006-00011 Age:7 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Angioneurotic Oedema Foreign Idrolax (Macrogol) PS ORAL 10 G (10 G 1

Initial or Prolonged Hypotension IN 1 DAY (S))

ORAL 1 DAY

Date:10/17/06ISR Number: 5132933-5Report Type:Expedited (15-DaCompany Report #863#3#2006-00013 Age:94 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Anaemia Idrolax (Macrogol) PS ORAL

Initial or Prolonged Thrombocytopenic Purpura Lorazepam

(Lorazepam) SS ORAL 1 MG (1 MG 1

IN 1 DAY(S)

Nicardipine

Hydrochloride

(Nicardipine

Hydrochloride) SS ORAL 40 MG (40 MG

(1 IN 1

DAY(S))

Forosemide SS ORAL 40 MG 1 IN 1

DAY

Tamsulosin

Hydrochloride SS ORAL .4 MG 1 IN 1

DAY

18-Apr-2007 11:25 AM Page: 143

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:10/17/06ISR Number: 5132934-7Report Type:Expedited (15-DaCompany Report #863#1#2006-00012 Age:35 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Life-Threatening Anaphylactic Shock Health Idrolax (Macrogol) PS ORAL 20 G (20 G 1

Professional IN 1 DAY(S))

Date:10/20/06ISR Number: 5135848-1Report Type:Expedited (15-DaCompany Report #060176 Age:7 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Abdominal Distension Consumer Polyethylene Glycol

Abnormal Behaviour 3350, Nf Powder For

Anxiety Solution PS ORAL 17G, DAILY,

Attention PO 5 YR

Deficit/Hyperactivity Magnesium Citrate C

Disorder Vitamin C C

Fluid Intake Reduced Fibersure C

Neurological Symptom

Refusal Of Treatment By

Relative

Speech Disorder

Tourette'S Disorder

Weight Increased

Date:10/25/06ISR Number: 5140686-XReport Type:Expedited (15-DaCompany Report #863#1#2006-00012 Age:35 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Life-Threatening Anaphylactic Shock Health Idrolax (Macrogol) PS ORAL 20 G (20 G 1

Feeling Abnormal Professional IN 1 DAY (S)) 1 DAY

Date:10/26/06ISR Number: 5139380-0Report Type:Direct Company Report #CTU 288076 Age:10 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Life-Threatening Abnormal Behaviour Miralax/Polyethylene

Disability Anxiety Glycol 3350 PS 1 CAPFUL

Other Autism Spectrum Disorder DAILY 1 YR

Required Depression

Intervention to Obsessive-Compulsive

Prevent Permanent Disorder

Impairment/Damage

Date:10/30/06ISR Number: 5142854-XReport Type:Expedited (15-DaCompany Report #002#1#2006-00307 Age:13 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Abdominal Pain Health Glycolax PS ORAL 17Q, 1 IN 1

Initial or Prolonged Local Swelling Professional D, ORAL

Rash Esomeprazole C

Swelling Face

18-Apr-2007 11:25 AM Page: 144

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:10/30/06ISR Number: 5142947-7Report Type:Expedited (15-DaCompany Report #863#3#2006-00014 Age:90 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Blood Creatinine Idrolax (Macrogol) PS ORAL 10 G (10 G 1

Initial or Prolonged Increased IN 1 DAY(S))

Disorientation Amlodipine Besilate

Hyponatraemia (Amlodipine

Sigmoiditis Besilate) SS ORAL 5 MG (5 MG 1

Subileus IN 1 DAY(S))

Paroxetine

(Paroxetine

Hydrochloride) SS ORAL 10 MG (10 MG

1 NI 1

DAY(S)) 22 DAY

Buflomedil

(Buflomedil) SS ORAL 600 MG (300

MG 2 IN 1

DAY(S))

Pantoprazole

(Pantoprazole) SS ORAL 40 G (40 G 1

IN 1 DAY(S))

Amloride (Amiloride

Hydrochloride,

Hydrochlorothiazide) C

Latanoprost

(Latanoprost) C

Bromazepam

(Bromazepam) C

Trimetazidine

Hydrochloride

(Trimetazidine

Hydrochloride) C

Fortimel C

Clopidogrel

Bisulphate

(Clopidogrel

Sulfate) C

Amoxicillin

(Amoxicillin

Trihydrate) C

Metronidazole

(Metronidazole) C

Date:10/30/06ISR Number: 5144317-4Report Type:Expedited (15-DaCompany Report #060182 Age:56 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Life-Threatening Blister Other Golytely PS ORAL 4 L, PO

Hypersensitivity Hydrochlorothiazide C

Hypotension Irbesartan C

Joint Swelling Nitroglycerin C

Myocardial Infarction Gemfibrozil C

Atorvastatin Calcium C

18-Apr-2007 11:25 AM Page: 145

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:11/01/06ISR Number: 5145862-8Report Type:Expedited (15-DaCompany Report #060163 Age:76 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Clavicle Fracture Consumer Halflytely And

Initial or Prolonged Dizziness Bisacodyl Tablets

Fall Bowel Prep Kit PS ORAL 20 MG/8 OZ,

Hyperhidrosis 1X, PO

Loss Of Consciousness Blood Pressure

Nausea Medication C

Neck Pain

Date:11/02/06ISR Number: 5144267-3Report Type:Direct Company Report #CTU 288473 Age:33 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Anxiety Polyethylene Glycol

Bowel Movement 3350 Powder 527

Irregularity Grams Affordable

Diarrhoea Pharmaceuticals Llc PS Affordable

Dyspepsia Pharmaceuticals Llc ORAL 2-4

Hypersensitivity TABLESPOONS

Malaise 1X DAY PO

Muscle Contractions

Involuntary

Pharyngeal Oedema

Pruritus

Urticaria

Vomiting

Date:11/03/06ISR Number: 5144784-6Report Type:Direct Company Report #CTU 288574 Age: Gender: I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Disability Drug Dispensing Error Mirapex 0.125mg

Drug Prescribing Error Boehringer Ingelheim PS Boehringer Ingelheim ORAL 1 TABLET 3

Medication Error TIMES DAILY

PO

Miralax 3350 Nf

Braintree Labs SS Braintree Labs ORAL 17 GRAM ONCE

DAILY PO

Date:11/06/06ISR Number: 5147380-XReport Type:Expedited (15-DaCompany Report #2006130041 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Condition Aggravated Consumer Visine Pure Tears

Vision Blurred (Glycerin,

Visual Acuity Reduced Polyethylene Glycol,

Hydroxypropylethylce

llulose) PS OPHTHALMIC 1-2 DROPS AS

NEEDED

VARIES,

OPHTHALMIC

18-Apr-2007 11:25 AM Page: 146

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:11/06/06ISR Number: 5151762-XReport Type:Expedited (15-DaCompany Report #CHNY2006CH01344 Age:39 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Abortion Spontaneous Foreign Neo Citran

Drug Exposure During Health Grippe/Erkltung Fr

Pregnancy Professional Erwachsene

Other (Nch)(Acetaminophen

(Paracetamol), PS ORAL 1 DF, QD,

ORAL

Movicol (Macrogol,

Potassium Chloride,

Sodium Bicarbonate,

Sodium Chloride) SS ORAL 1 DF, QD,

ORAL

Lecicarbon

(Lecithin, Sodium

Bicarbonate, Sodium

Phosphate Monobasic

(Anhydrate)) SS RECTAL 1 DF, QD,

RECTAL

Riopan (Magaldrate) SS ORAL ORAL

Pantozol

(Pantoprazole

Sodium) Tablet C

Transipeg /Sch/

(Macrogol 3350,

Potassium Chloride,

Sodium Bicarbonate,

Sodium Chlor...) C

Date:11/09/06ISR Number: 5151578-4Report Type:Expedited (15-DaCompany Report #060189 Age:79 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Angioneurotic Oedema Health Golytely PS ORAL 1 GLASSES,

Swollen Tongue Professional 1X, PO

Blood Pressure

Medication C

Date:11/09/06ISR Number: 5151898-3Report Type:Expedited (15-DaCompany Report #863#3#2006-00016 Age:96 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Blood Creatinine Idrolax (Macrogol) PS ORAL 10 G ORAL

Initial or Prolonged Increased Colchicine

Blood Pressure Diastolic (Colchicine) SS ORAL ORAL 1 MON

Decreased Alimemazine Tartrate

Dehydration (Alimemazine

Diarrhoea Tartrate) C

General Physical Health Amiodarone

Deterioration Hydrochloride

Hypokalaemia (Amiodarone

Hyponatraemia Hydrochloride) C

Weight Decreased Paracetamol

(Paracetamol) C

Acetylsalicylate

Lysine

(Acetylsalicylate

Lysine) C

18-Apr-2007 11:25 AM Page: 147

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:11/09/06ISR Number: 5151899-5Report Type:Expedited (15-DaCompany Report #863#3#2006-00015 Age:77 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Pruritus Generalised Idrolax (Macrogol) PS ORAL 10 G (10 G

Initial or Prolonged Urticaria 1IN 1 DAY(S))

ORAL

Urapidil (Urapidil) SS ORAL 60 MG ORAL

Insulin Glargine

(Insulin Glargine) SS SUBCUTANEOUS SUBCUTANEOUS 16 DAY

Celiprolol

(Celiprolol) SS ORAL 200 MG ORAL

Furosemide

(Furosemide) SS ORAL 40 MG ORAL

Pantoprazole

(Pantoprazole) SS ORAL 40 MG ORAL

Pantoprazole

(Pantoprazole) C

Levothyroxine Sodium

(Levothyroxine

Sodium) C

Allopurinol

(Allopurinol) C

Ferrous Fumarate

(Ferrous Fumarate) C

Diosmin (Diosmin) C

Di-Gesic

(Dextropropoxyphene

Hydrochloride,

Paracetamol) C

Date:11/10/06ISR Number: 5152111-3Report Type:Direct Company Report #CTU 288975 Age:53 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Abdominal Pain Upper Polyethylene Gl 3350

Diarrhoea Pwd 527g Teva PS Teva UP TO 1

Flatulence CAPFUL ONCE A

Pharmaceutical Product DAY

Complaint

Date:11/13/06ISR Number: 5152086-7Report Type:Direct Company Report #CTU 289211 Age:33 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Dysgeusia Polyethylene Gi 3350

Odynophagia Pwd 527g Teva PS Teva MIX 17 GRAMS

Pharmaceutical Product (1 CAPFUL) IN

Complaint 8 OZS OF

Stomatitis WATER AND

Throat Irritation DRINK TWICE A

Birth Control C

Date:11/13/06ISR Number: 5152089-2Report Type:Direct Company Report #CTU 289208 Age: Gender:Male I/FU:I

Outcome PT

Dysgeusia

Pharmaceutical Product

18-Apr-2007 11:25 AM Page: 148

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Complaint

Report Source Product Role Manufacturer Route Dose Duration

Polyethylene Glycol

Powder Teva PS Teva MIX ONE

CAPFUL (17

GRAMS) IN

WATER OR

JUICE AND

Date:11/13/06ISR Number: 5153391-0Report Type:Expedited (15-DaCompany Report #HQWYE168102NOV06 Age:90 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Hyponatraemia Health Inipomp

Initial or Prolonged Sigmoiditis Professional (Pantoprazole,

Vomiting Other Tablet, Delayed

Release) PS ORAL 40 MG 1X PER

1 DAY

Amlor (Amlodipine

Besilate) SS ORAL 5 MG 1X PER 1

DAY

Buflomedil

(Buflomedil) SS ORAL 300 MG 2X PER

1 DAY

Forlax (Macrogol) SS ORAL 1 DOSAGE FORM

1X PER 1 DAY

Moduretic (Amiloride

Hydrochloride/Hydroc

hlorothiazide) SS ORAL 0.5 DOSAGE

FORM 1X PER 1

DAY

Paroxetine

Hydrochloride

(Paroxetine

Hydrochloride) SS ORAL 10 MG 1X PER

1 DAY 22 DAY

Xalantan

(Latanoprost) C

Bromazepam C

Vastarel

(Trimetazidine

Hydrochloride) C

Protein Supplements C

.... C

'''' C

Plavix (Clopidogrel

Sulfate) C

Clamoxyl

(Amoxicillin

Trihydrate) C

Flagyl

(Metronidazole) C

18-Apr-2007 11:25 AM Page: 149

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:11/13/06ISR Number: 5155720-0Report Type:Expedited (15-DaCompany Report #2006135049 Age:81 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Corneal Abrasion Consumer Visine Pure Tears

(Glycerin,

Polyehtylene Glycol,

Hydroxypropylmethylc

ellulose) PS OPHTHALMIC 1-2 DROPS

EVERY 4

HOURS,

OPHTHALMIC

Ascorbic Acid C

Tocopherol C

Ergocalciferol C

Retinol C

Date:11/14/06ISR Number: 5151475-4Report Type:Direct Company Report #CTU 289311 Age: Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Dysgeusia Polyethylene Glycol

Pharmaceutical Product 3350 Powder For Oral

Complaint Solution PS Kremers Urban ORAL 17GM MIXED IN

WATER, DRINK

ORALLYTWICE A

DAY

Date:11/14/06ISR Number: 5151513-9Report Type:Direct Company Report #CTU 289305 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Dysgeusia Polyethylene Glycol

Nausea 3350 Pwdr 527gm PS Teva 17GM MIXED IN

Pharmaceutical Product WATER, JUICE

Complaint & DRINK ONCE

OR TWICE

DAILY

Date:11/14/06ISR Number: 5151514-0Report Type:Direct Company Report #CTU 289306 Age:47 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Drug Ineffective Polyethylene Glycol

Pharmaceutical Product 3350 PS Teva MIX 17 GRAMS

Complaint (1 CAPFUL) IN

WATER AND

DRINK DAILY

(DURATION:

Date:11/14/06ISR Number: 5153264-3Report Type:Direct Company Report #USP 58261 Age: Gender: I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Drug Dispensing Error Miralax PS Braintree

Medication Error Laboratories, Inc. FOR SOLUTION

Miralax SS Braintree

Laboratories, Inc FOR SOLUTION

18-Apr-2007 11:25 AM Page: 150

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:11/14/06ISR Number: 5155372-XReport Type:Expedited (15-DaCompany Report #002#2#2006-00317 Age:72 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Life-Threatening Cardiac Arrest Consumer Colyte-For-Oral-Solu

Hospitalization - Dyspnoea tion (Polyethylene

Initial or Prolonged Fluid Overload Glycol 3350) PS ORAL 4L, LONCE,

Respiratory Failure ORAL

Potassium C

Steroids C

Furosemide C

Date:11/20/06ISR Number: 5155028-3Report Type:Direct Company Report #CTU 289602 Age:37 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Abdominal Distension Glycolax 1 Capful

Abdominal Pain Powder Po Qd PS ORAL 1 CAPFUL

Constipation POWDER PO QD

Pharmaceutical Product

Complaint

Date:11/20/06ISR Number: 5159575-XReport Type:Expedited (15-DaCompany Report #002#8#2006-00324 Age:77 YR Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Ascites Literature Colyte-For-Oral-Solu

Initial or Prolonged Blood Albumin Decreased tion (Polyethylene

Blood Creatinine Glycol 3350) PS 4L, ONCE

Increased Laxatives C

Blood Potassium Decreased

Blood Pressure Systolic

Increased

Body Temperature

Increased

Colonic Obstruction

Haematocrit Decreased

Haemoglobin Decreased

Intestinal Gangrene

Platelet Count Decreased

Protein Total Decreased

Respiratory Rate

Increased

Volvulus

White Blood Cell Count

Decreased

Date:11/21/06ISR Number: 5162257-1Report Type:Expedited (15-DaCompany Report #060197 Age:62 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Colitis Ischaemic Health Halflytely And

Diverticulum Professional Bisacodyl Tablets

Haemorrhoids Bowel Prep

Rectal Haemorrhage Kit PS ORAL 20 MG/2 L,

1X, PO

Paxil C

Lovastatin C

Detrol C

18-Apr-2007 11:25 AM Page: 151

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Claritin C

Date:11/27/06ISR Number: 5164410-XReport Type:Direct Company Report #CTU 290019 Age: Gender:Male I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Vomiting Polyethylene Glycol

3350 Nf Powder For

Oral Solution PS Par ORAL 1 CAPFUL

TWICE A DAY

VIA NG TUB

Polyethylene Glycol

3350 Nf Powder For

Oral Solution SS ORAL 1 CAPFUL ONCE

A DAY ORAL

Date:11/27/06ISR Number: 5165125-4Report Type:Expedited (15-DaCompany Report #HQWYE740116NOV06 Age:84 YR Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Life-Threatening Anaemia Health Avlocardyl

Leukopenia Professional (Propranolol

Other Hydrochloride,

Tablet) PS ORAL 20 MG 1X PER

1 DAY ORAL

Coversyl

(Perindopril) SS ORAL 4 MG 1X PER 1

DAY ORAL

Deroxat (Paroxetine

Hydrochloride) SS ORAL 20 MG 1X PER

1 DAY ORAL

Diffu K (Potassium

Chloride) SS

Forlax (Macrogol) SS

Inipomp

(Pantoprazole,

Tablet, Delayed

Release) SS ORAL 40 MG 1X PER

1 DAY ORAL

Motilium

(Domperidone) SS ORAL ORAL

Neo-Mercazole

(Carbimazole) SS ORAL 20 MG 1X PER

1 DAY ORAL 18 DAY

Date:11/28/06ISR Number: 5162458-2Report Type:Direct Company Report #CTU 290199 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other No Adverse Effect Half-Lytely

Prep-Used & Was

Disposed PS ORAL X 1 AS FOR

COLONOSCOPY

PREP ORAL

18-Apr-2007 11:25 AM Page: 152

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Date:11/29/06ISR Number: 5163807-1Report Type:Direct Company Report #CTU 290378 Age: Gender:Female I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Oedema Peripheral Polyethylene Glycol

Rash Pruritic 3350, Nf Braintree

Skin Discolouration Laboratories PS Braintree

Laboratories ORAL 17GR

DISSOLVED IN

8 OZ LIQUID

TWICE DAILY

PO

Date:11/29/06ISR Number: 5166300-5Report Type:Expedited (15-DaCompany Report #002#2#2006-00317 Age:72 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Life-Threatening Cardiac Arrest Consumer Colyte-For-Oral-Solu

Hospitalization - Cardiac Failure tion (Polyethylene

Initial or Prolonged Congestive Glycol 3350) PS ORAL 41, 1ONCE,

Colonic Polyp ORAL

Concomitant Disease Potassium C

Aggravated Steroids C

Fluid Overload Furosemide C

Haemorrhoids Many Concomitant

Lung Infection Drugs C

Respiratory Failure

Date:11/30/06ISR Number: 5161741-4Report Type:Expedited (15-DaCompany Report #JP-GLAXOSMITHKLINE-B0446482A Age:1 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Hospitalization - Bacterial Infection Sawacillin PS Glaxosmithkline ORAL 2 DAY

Initial or Prolonged Convulsion Dormicum SS UNKNOWN 1.2MGH per

Disseminated day 6 DAY

Intravascular Coagulation Froben SS ORAL 50MG per day 32 DAY

Drug Hypersensitivity Glovenin SS Glaxosmithkline UNKNOWN 2GK per day

Epidermolysis Flumarin SS UNKNOWN 100MGK per

Excoriation day

Hyperthermia Horizon SS Glaxosmithkline INTRAVENOUS 1 DAY

Ill-Defined Disorder Flomox SS UNKNOWN

Kawasaki'S Disease Polyethylene Glycol

Pyrexia Treated Human Normal

Rash Immunoglobulin SS Glaxosmithkline UNKNOWN

Acetaminophen C Glaxosmithkline RECTAL 100MG As

required 20 DAY

Gaster C INTRAVENOUS 6 DAY

Venilon C Glaxosmithkline INTRAVENOUS 2GK per day 2 DAY

Ulinastatin C UNKNOWN 50000UNIT Six

times per day 8 DAY

Date:12/01/06ISR Number: 5167673-XReport Type:Direct Company Report #CTU 290540 Age:60 YR Gender:Female I/FU:I

Outcome PT

Other Anal Discomfort

Burning Sensation

Dry Mouth

Dry Throat

18-Apr-2007 11:25 AM Page: 153

FDA - Adverse Event Reporting System (AERS)

Freedom Of Information (FOI) Report

Erythema

Gastrointestinal Disorder

Oedema Peripheral Report Source Product Role Manufacturer Route Dose Duration

Throat Irritation Polyethylene Glycol

(Peg) Anabolic Inc PS Anabolic Inc ORAL 17 GRAMS

DAILY ORALLY

Date:12/01/06ISR Number: 5169067-XReport Type:Expedited (15-DaCompany Report #2006135049 Age:81 YR Gender:Female I/FU:F

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Corneal Abrasion Consumer Visine Pure Tears PS OPHTHALMIC 1-2 DROPS

EVERY 4

HOURS,

OPHTHALMIC

Ascorbic Acid

(Ascorbic Acid) C

Tocopherol

(Tocopherol) C

Calcium (Calcium) C

Ergocalciferol

(Ergocalciferol) C

Retinol (Retinol) C

Date:12/01/06ISR Number: 5228942-8Report Type:Periodic Company Report #147305USA Age: Gender: I/FU:I

Outcome PT Report Source Product Role Manufacturer Route Dose Duration

Other Dyspnoea Health Polyethylene Glycol

Pharyngeal Oedema Professional Powder For Oral

Sign In

FDA adverse reactions (665)

Recommended Posts

Guest guest

Link to comment

Share on other sites

Join the conversation

Activity