Re: Seroxat (paroxetine) - suicidality warning for both ADULT & PEDIATRIC patients

June 25, 2004

This is just an out, a way of covering their asses to keep them from

being sued -- like the warnings on cigarettes. The only adverse

reaction they address is suicide and they just admitted that suicide

can occur but they don't state it as an adverse side effect. This new

wording is nothing more than the old " Of course some people kill

themselves, they were depressed, that's why they were taking the drug.

"

We are losing and they are winning.

> >

> > Other Products:

> > Return to Top

> >

> > http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#wellbutrin

> >

> > 2004 Medical Product Safety Alerts, listed in reverse

> chronological

> > order (most recent first). For an alphabetical listing, return to

> > the categories on this page. You may also search the entire

> MedWatch

> > site by keyword at the top of this Safety Information page.

> >

> > = Adobe Acrobat file (.pdf file), viewed with free Acrobat Reader

> > software. For more information, go to the MedWatch " downloads "

> page

> > at http://www.fda.gov/medwatch/getforms.htm

> >

> > Serzone (nefazodone hydrochloride) Tablets

> > Audience: Neuropsychiatric healthcare professionals

> > FDA and Bristol-Myers Squibb notified healthcare professionals of

> > revisions to the INDICATIONS AND USAGE, DOSAGE AND ADMINISTRATION,

> > and WARNINGS sections to encourage healthcare providers to engage

> in

> > a thorough risk-benefit analysis, including consideration of the

> > risk of hepatic failure associated with Serzone treatment, when

> > deciding among alternative treatments available for depression. In

> > addition, healthcare providers and consumers are cautioned about

> the

> > need for close observation of patients being treated with

> > antidepressants for clinical worsening of the symptoms of

> > depression, for the emergence of suicidality, and for the

> emergence

> > of a variety of other symptoms that may represent a worsening of

> the

> > patient's condition.

> >

> > [June 18, 2004 Letter - Bristol-Myers Squibb]

> > [April 2004 Revised Label - Bristol-Myers Squibb]

> >

> > Return to Top | MedWatch Home | MedWatch Safety Info | Online

> > MedWatch Report | Contact Medwatch

> >

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> --

> > -----------

> >

> > Wellbutrin (bupropion hydrochloride) Tablets

> > Wellbutrin SR (bupropion hydrochloride) Sustained-Release Tablets

> > Wellbutrin XL (bupropion hydrochloride) Extended-Release Tablets

> > Audience: Neuropsychiatric healthcare professionals

> > FDA and GlaxoKline notified healthcare professionals of

> > revisions to the WARNINGS and PRECAUTIONS sections of labeling to

> > alert healthcare professionals that patients with major depressive

> > disorder, both adult and pediatric, may experience worsening of

> > their depression and/or the emergence of suicidal ideation and

> > behavior (suicidality), whether or not they are taking

> > antidepressant medications. The warning recommends patients being

> > treated with antidepressants be observed closely for clinical

> > worsening and suicidality, especially at the beginning of a course

> > of drug therapy, or at the time of dose changes, either increases

> or

> > decreases.

> >

> > [May 2004 Letter - GlaxoKline]

> > [April 2004 Wellbutrin XL Revised Label - GlaxoKline]

> >

> > Return to Top | MedWatch Home | MedWatch Safety Info | Online

> > MedWatch Report | Contact Medwatch

> >

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> --

> > -----------

> >

> > Paxil (paroxetine hydrochloride) Tablets

> > Paxil CR (paroxetine hydrochloride) Controlled-Release Tablets

> > Audience: Neuropsychiatric healthcare professionals

> > FDA and GlaxoKline notified healthcare professionals of

> > revisions to the WARNINGS and PRECAUTIONS sections of labeling to

> > alert healthcare professionals that patients with major depressive

> > disorder, both adult and pediatric, may experience worsening of

> > their depression and/or the emergence of suicidal ideation and

> > behavior (suicidality), whether or not they are taking

> > antidepressant medications. The warning recommends patients being

> > treated with antidepressants be observed closely for clinical

> > worsening and suicidality, especially at the beginning of a course

> > of drug therapy, or at the time of dose changes, either increases

> or

> > decreases.

> >

> > [May 2004 Letter - GlaxoKline]

> > [April 2004 Paxil Revised Label - GlaxoKline]

> > [April 2004 Paxil CR Revised Label - GlaxoKline]

> >

> > Return to Top | MedWatch Home | MedWatch Safety Info | Online

> > MedWatch Report | Contact Medwatch

> >

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> --

> > -----------

> >

> > Domperidone

> > Audience: Consumers and healthcare professionals

> > FDA warned healthcare professionals and breastfeeding women not to

> > use an unapproved drug, domperidone, to increase milk production

> > (lactation). The agency is concerned with the potential public

> > health risks associated with domperidone. FDA took these actions

> > because it has become aware that some women are purchasing this

> drug

> > from compounding pharmacies and from foreign sources. Although

> > domperidone is approved in several countries outside the U.S. to

> > treat certain gastric disorders, it is not approved in any

> country,

> > including the U.S., for enhancing breast milk production in

> > lactating women and is also not approved in the U.S. for any

> > indication.

> >

> > [June 10, 2004 FDA Talk Paper - FDA]

> >

> > Return to Top | MedWatch Home | MedWatch Safety Info | Online

> > MedWatch Report | Contact Medwatch

> >

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> --

> > -----------

> >

> > Roche Diagnostics Tecan Clinical Workstation

> > Audience: Clinical laboratory specialists and healthcare

> > professionals

> > FDA and Roche Diagnostics notified healthcare professionals of a

> > Class I Recall for the Tecan Clinical Workstation (TCW), used with

> > Roche Diagnostics Amplicor CT/NG test for the detection of

> Chlamydia

> > and gonorrhea. A software error in the workstation software may

> > cause a mismatch among patient samples and test results resulting

> in

> > false positive and false negative results. This could lead to

> > mistreatment and unneeded exposure to antibiotics. Untreated

> > Chlamydia and gonorrhea infections may lead to pelvic inflammatory

> > disease, infertility, ectopic pregnancy, or other conditions.

> >

> > [uPDATE June 18, 2004 - Recall information added for COBAS GUI

> > Interface and RoboNet software]

> > [June 09, 2004 Recall Notice - FDA]

> >

> > Return to Top | MedWatch Home | MedWatch Safety Info | Online

> > MedWatch Report | Contact Medwatch

> >

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> --

> > -----------

> >

> > Crestor (rosuvastatin)

> > Audience: Physicians, pharmacists, and other healthcare

> > professionals

> > FDA issued a Public Health Advisory notifying healthcare

> > professionals of a revised package insert for use in the 22 member

> > states of the European Union (EU). The changes to the European

> > labeling are in response to adverse event reports in patients

> > receiving Crestor and highlight certain patient populations who

> may

> > be at an increased risk for serious muscle toxicity (myopathy)

> > associated with Crestor use, especially at the highest approved

> dose

> > of 40 mg. These risk factors and many of the recommendations for

> how

> > to minimize the risk of myopathy are already captured in the FDA

> > approved labeling for Crestor in the U.S. FDA alerted physicians

> to

> > carefully read the Crestor product label and follow the

> > recommendations for starting doses, dose adjustments, and maximum

> > daily doses to minimize the risk of myopathy in individual

> patients.

> >

> > [June 09, 2004 Public Health Advisory - FDA]

> >

> > Return to Top | MedWatch Home | MedWatch Safety Info | Online

> > MedWatch Report | Contact Medwatch

> >

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> --

> > -----------

> >

> > Arjo MINSTREL Patient Lifts

> > Audience: Hospital and nursing home administrators and risk

> managers

> > FDA and Arjo, Inc. notified healthcare professionals of a Class I

> > recall of the MINSTREL patient lift. There are two mechanical

> > problems associated with the lifts: the first involves the hanger

> > bar detaching from the lift, resulting in the patient falling to

> the

> > ground because of a missing spring washer; the second problem

> > involves a bolt in the foot pedal assembly becoming loose which

> > allows the foot pedal assembly to fall off of the lift. This

> results

> > in the lift becoming unstable and the patient possibly falling.

> > Facilities should either inspect their lifts and follow the

> > instructions in the Field Correction/Recall letter sent to all

> > facilities or they should take the lifts out of service until they

> > can be inspected by an Arjo service engineer.

> >

> > [May 27, 2004 Recall Notice - FDA]

> > [May 26, 2004 Press Release - Arjo, Inc.]

> >

> > Return to Top | MedWatch Home | MedWatch Safety Info | Online

> > MedWatch Report | Contact Medwatch

> >

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> --

> > -----------

> >

> > Paradigm Quick-set Plus Insulin Administration Set

> > Audience: Healthcare professionals, hospital risk managers

> > FDA and Medtronic, Inc. notified healthcare professionals of a

> Class

> > I recall of Quick-set Plus infusion sets because of problems with

> > bending of the infusion set's cannula or unintentional

> disconnection

> > of the set at the insertion site that can interrupt insulin flow

> to

> > diabetics who use them. These problems have resulted in a number

> of

> > serious injuries, including some hospitalizations.

> >

> > [May 20, 2004 Recall Notice - FDA]

> > [May 18, 2004 Press Release - Medtronic, Inc.]

> >

> > Return to Top | MedWatch Home | MedWatch Safety Info | Online

> > MedWatch Report | Contact Medwatch

> >

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> --

> > -----------

> >

> > Children's Motrin Grape Chewable Tablets

> > Audience: Pharmacists and consumers

> > FDA and McNeil alerted healthcare professionals that one

> > manufacturing lot (Lot # JAM108, exp 1/06) of Children's Motrin

> > (ibuprofen) Grape Chewable Tablets may mistakenly contain Tylenol

> 8-

> > Hour extended release (acetaminophen) Geltabs. Lot # JAM108 was

> > distributed nationwide to wholesale and retail customers between

> > February 5 and April 1, 2004. The bottles are labeled as

> containing

> > 24 tablets. The Tylenol 8-Hour product provides an adult dose of

> > acetaminophen, and use of this adult product could provide more

> than

> > the recommended dose (overdose) for children.

> >

> > [May 12, 2004 Press Release - McNeil Consumer & Specialty

> > Pharmaceuticals]

> >

> > Return to Top | MedWatch Home | MedWatch Safety Info | Online

> > MedWatch Report | Contact Medwatch

> >

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> --

> > -----------

> >

> > PRECISE RX Nitinol Stent Transhepatic Biliary System

> > Audience: General surgeons and endovascular healthcare

> professionals

> > Cordis and FDA notified healthcare professionals of a Class 1

> recall

> > for the revised instructions for use, not cleared by the FDA, and

> > contained in a notification mailed to Cordis' endovascular

> customers

> > on March 29, 2004. Use of the stent system, indicated for

> treatment

> > of obstruction of the bile duct due to malignancies, is reported

> to

> > result in serious problems in some cases when used in the vascular

> > system.

> >

> > On May 4, 2004 Cordis sent a follow-up notification to customers

> > describing nine patient injuries due to air embolism, including

> > seizure and coma, as well as seven incidents of device malfunction

> > in connection with the use of this system outside of its approved

> > indication. Cordis stated that they were recalling the March 29,

> > 2004 instructions with a strong recommendation that physicians

> limit

> > their use of the PRECISE RX Stent to indicated uses only.

> >

> > [May 04, 2004 Recall Notice - FDA]

> >

> > Return to Top | MedWatch Home | MedWatch Safety Info | Online

> > MedWatch Report | Contact Medwatch

> >

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> --

> > -----------

> >

> > Desyrel (trazodone hydrochloride)

> > Audience: Neuropsychiatric healthcare professionals

> > FDA and Bristol-Myers Squibb notified healthcare professionals of

> > revisions to the CLINICAL PHARMACOLOGY and PRECAUTIONS sections of

> > the Desyrel labeling. Desyrel is indicated for the treatment of

> > depression. In vitro drug metabolism studies suggest that there is

> a

> > potential for drug interactions when trazodone is given with the

> > CYP3A4 inhibitors ketoconazole, ritonavir, and indinavir. It is

> > likely that CYP3A4 inhibitors may lead to substantial increases in

> > trazodone plasma concentrations with the potential for adverse

> > effects. If trazodone is used with a potent CYP3A4 inhibitor, a

> > lower dose of trazodone should be considered. Conversely,

> > carbamazepine reduced plasma concentrations of trazodone when

> > coadministered. Patients should be closely monitored to see if

> there

> > is a need for an increased dose of trazodone when taken with

> > carbamazepine.

> >

> > [May, 2004 Letter - Bristol-Myers Squibb]

> > [september, 2003 Label - Bristol-Myers Squibb]

> >

> > Return to Top | MedWatch Home | MedWatch Safety Info | Online

> > MedWatch Report | Contact Medwatch

> >

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> --

> > -----------

> >

> > Oxandrin (oxandrolone, USP)

> > Audience: Physicians, pharmacists, and other healthcare

> professionals

> > Savient Pharmaceuticals, Inc. notified healthcare professionals of

> > an important drug interaction between Oxandrin, a synthetic

> > derivative of testosterone, and the oral anticoagulant warfarin

> for

> > systemic anticoagulation. Oxandrin is indicated as adjunctive

> > therapy to promote weight gain and for the relief of the bone pain

> > frequently accompanying osteoporosis. Concurrent dosing of

> Oxandrin

> > and warfarin may result in unexpectedly large increases in the

> > International Normalized Ratio (INR) or prothrombin time (PT).

> When

> > Oxandrin is prescribed to patients being treated with warfarin,

> > doses of warfarin may need to be decreased significantly to

> maintain

> > a desirable INR level and diminish the risk of potentially serious

> > bleeding.

> >

> > [April 20, 2004 Letter - Savient Pharmaceuticals]

> >

> > Return to Top | MedWatch Home | MedWatch Safety Info | Online

> > MedWatch Report | Contact Medwatch

> >

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> --

> > -----------

> >

> > Zelnorm (tegaserod maleate)

> > Audience: Gastroenterologists and other healthcare professionals

> > The FDA and Novartis notified healthcare professionals of an

> > important drug warning and prescribing information for Zelnorm, a

> > serotonin 5-HT4 receptor partial agonist indicated for the short-

> > term treatment of women with irritable bowel syndrome (IBS) whose

> > primary bowel symptom is constipation. This new information

> relates

> > to a Warning for serious consequences of diarrhea and a Precaution

> > for rare reports of ischemic colitis in post marketing use of

> > Zelnorm.

> >

> > [April 26, 2004 Letter - Novartis]

> > [April 2004 Revised Label - Novartis]

> > [April 28, 2004 Drug Information Page - FDA]

> >

> > Return to Top | MedWatch Home | MedWatch Safety Info | Online

> > MedWatch Report | Contact Medwatch

> >

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> --

> > -----------

> >

> > Medtronic Micro Jewell II Model 7223Cx and GEM DR Model 7271

> > Implantable Cardioverter Defibrillators (ICD)

> > Audience: Cardiologists and other healthcare professionals

> > The FDA notified healthcare professionals of a Class I recall of

> > implantable cardioverter defibrillators (ICDs) from Medtronic Inc.

> > of Minneapolis, Minnesota. Some Medtronic ICDs were found to have

> > defective high voltage capacitors that may take longer than normal

> > to charge near the end of the battery service life and could cause

> a

> > delay in delivery or a non-delivery of shock therapy. This could

> > result in patient injury or death because patients are not

> receiving

> > the appropriate therapy in time. A total of 6,268 of the affected

> > ICDs were manufactured, of which about 1,800 are thought to be

> still

> > implanted in patients worldwide. Patients with Medtronic ICDs with

> > these model numbers should contact their physicians for further

> > information and advice.

> >

> > [April 4, 2004 Recall Notice - FDA]

> > [April 16, 2004 Press Release - Medtronic]

> >

> > Return to Top | MedWatch Home | MedWatch Safety Info | Online

> > MedWatch Report | Contact Medwatch

> >

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> --

> > -----------

> >

> > Cytotec Solutions, Inc. Products

> > Audience: Consumers, pharmacists, and other healthcare

> professionals

> > FDA warned consumers not to purchase or consume products marketed

> > as " street drug alternatives " by Cytotec Solutions, Inc., of

> Tampa,

> > Fla. FDA analyses of products manufactured or distributed by

> Cytotec

> > Solutions Inc., found the drugs diphenhydramine HCl,

> > dextromethorphan, ephedrine, and the controlled substances GBL and

> > GHB. Although this firm is no longer producing these products,

> they

> > remain under investigation and FDA is working to identify and

> > address additional distributors of the products. The agency is

> > issuing this warning because consumers may still have these

> products

> > in their possession or may be able to buy them commercially. A

> list

> > of product names is included in the FDA Press Release.

> >

> > [April 9, 2004 Press Release - FDA]

> >

> > Return to Top | MedWatch Home | MedWatch Safety Info | Online

> > MedWatch Report | Contact Medwatch

> >

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> --

> > -----------

> >

> > Abilify (aripiprazole)

> > Audience: Neuropsychiatric healthcare professionals

> > FDA and Bristol-Myers Squibb notified healthcare professionals of

> > revision to the WARNINGS section of labeling, describing the risk

> of

> > hyperglycemia and diabetes in patients taking Abilify. FDA asked

> all

> > manufacturers of atypical antipsychotic medications, including

> > Bristol-Myers Squibb, to add this Warning statement to labeling.

> >

> > [March 25, 2004 Letter - FDA]

> > [March, 2004 Revised label - Bristol-Myers Squibb]

> >

> > Return to Top | MedWatch Home | MedWatch Safety Info | Online

> > MedWatch Report | Contact Medwatch

> >

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> --

> > -----------

> >

> > Seroquel (quetiapine fumarate)

> > Audience: Neuropsychiatric healthcare professionals

> > FDA and AstraZeneca notified healthcare professionals of revision

> to

> > the WARNINGS section of labeling, describing the increased risk of

> > hyperglycemia and diabetes in patients taking Seroquel. FDA has

> > asked all manufacturers of atypical antipsychotic medications,

> > including AstraZeneca, to add this Warning statement to labeling.

> >

> > [uPDATE - April 22, 2004 Letter - AstraZeneca]

> > [January 30, 2004 Letter - AstraZeneca]

> > [January 2004 Revised Label - AstraZeneca]

> >

> > Return to Top | MedWatch Home | MedWatch Safety Info | Online

> > MedWatch Report | Contact Medwatch

> >

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> --

> > -----------

> >

> > Clozaril (clozapine)

> > Audience: Neuropsychiatric healthcare professionals

> > FDA and Novartis notified healthcare professionals of revision to

> > the WARNINGS section of labeling, describing the increased risk of

> > hyperglycemia and diabetes in patients taking Clozaril. FDA has

> > asked all manufacturers of atypical antipsychotic medications,

> > including Novartis, to add this Warning statement to labeling.

> >

> > [April 1, 2004 Letter - Novartis]

> > [December 2003 Revised Label - Novartis]

> >

> > Return to Top | MedWatch Home | MedWatch Safety Info | Online

> > MedWatch Report | Contact Medwatch

> >

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> --

> > -----------

> >

> > Absorbable Hemostatic Agents

> > Audience: Surgeons and operating room supervisory personnel

> > The FDA Center for Devices and Radiological Health (CDRH) issued a

> > Public Health Notification concerning a serious adverse event that

> > can occur with the use of an absorbable hemostatic agent, a device

> > used to promote coagulation and stop internal bleeding during

> > surgical procedures. Since 1996, FDA has received reports of over

> > 110 adverse events related to absorbable hemostatic agents. Eleven

> > of the events resulted in paralysis or other neural deficits.

> These

> > events continue to occur despite specific advice and warnings in

> the

> > device labeling. CDRH provided recommendations to minimize the

> risk

> > of adverse events in patients receiving an absorbable hemostatic

> > agent during a surgical procedure.

> >

> > [April 02, 2004 Public Health Notification - FDA]

> >

> > Return to Top | MedWatch Home | MedWatch Safety Info | Online

> > MedWatch Report | Contact Medwatch

> >

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> --

> > -----------

> >

> > VITEK GPS-107 gram positive susceptibility cards

> > Audience: Clinical laboratory specialists and healthcare

> > professionals

> > (March 26, 2004) bioMerieux, Inc. of Hazelwood, Missouri issued a

> > Class I recall of VITEK GPS-107 gram positive susceptibility

> cards,

> > lot M83X, catalog #V4368. These cards are used with the VITEK

> System

> > in clinical laboratories as a in-vitro test to determine patient's

> > susceptibility of various bacteria to antibiotic treatment. Some

> of

> > the GPS-107 cards were stamped with an incorrect card code causing

> > the system to read and report the cards incorrectly. Use of the

> > defective cards may pose a risk of potentially life threatening

> > consequences due to inaccurate test results. (Updated 4/1/2004 to

> > provide correct lot number.)

> >

> > (UPDATE May 14, 2004) bioMerieux expanded its recall to include an

> > additional lot, B28E.

> >

> > [April 20, 2004 Recall Notice - FDA]

> > [January 28, 2004 Recall Notice - FDA]

> >

> > Return to Top | MedWatch Home | MedWatch Safety Info | Online

> > MedWatch Report | Contact Medwatch

> >

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> --

> > -----------

> >

> > Major Twice-A-Day 12 Hour Nasal Spray

> > Audience: Pharmacists and consumers

> > Propharma, Inc., Miami, Florida issued a recall of Major Twice-A-

> Day

> > 12 Hour Nasal Spray (Lot #K4496, Exp 10/06) because the lot was

> > contaminated with Burkholderia cepacia bacteria. This product is a

> > nasal decongestant containing the active ingredient oxymetazoline

> > hydrochloride 0.05%. The entire lot was distributed nationwide to

> > wholesalers, pharmacies, hospitals and retailers. Use of this

> > contaminated product could cause serious or potentially life-

> > threatening infections in patients with compromised immune

> systems,

> > particularly individuals with cystic fibrosis. The lot number and

> > expiration date are found on the bottom of the carton and the back

> > of the bottle label.

> >

> > [uPDATE March 26, 2004 Press Release - Propharma]

> > [March 18, 2004 Press Release - Propharma]

> >

> > Return to Top | MedWatch Home | MedWatch Safety Info | Online

> > MedWatch Report | Contact Medwatch

> >

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> --

> > -----------

> >

> > Zyprexa (olanzapine)

> > Audience: Neuropsychiatric healthcare professionals

> > FDA and Lilly notified healthcare professionals of revision to the

> > WARNINGS section of labeling, describing the increased risk of

> > hyperglycemia and diabetes in patients taking Zyprexa. FDA has

> asked

> > all manufacturers of atypical antipsychotic medications, including

> > Lilly, to add this Warning statement to labeling.

> >

> > [March 2004 Letter - Lilly] PDF version

> > [January 2004 Revised Label - Lilly]

> >

> > Return to Top | MedWatch Home | MedWatch Safety Info | Online

> > MedWatch Report | Contact Medwatch

> >

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> --

> > -----------

> >

> > Public Health Advisory: Antidepressant Use in Children,

> Adolescents,

> > and Adults

> > Audience: Neuropsychiatric healthcare professionals and consumers

> > The FDA asked manufacturers of the following antidepressant drugs

> to

> > include in their labeling a Warning statement that recommends

> close

> > observation of adult and pediatric patients for worsening

> depression

> > or the emergence of suicidality when treated with these agents.

> The

> > drugs that are the focus of this new Warning are: Prozac

> > (fluoxetine); Zoloft (sertraline); Paxil (paroxetine); Luvox

> > (fluvoxamine); Celexa (citalopram); Lexapro (escitalopram);

> > Wellbutrin (bupropion); Effexor (venlafaxine); Serzone

> (nefazodone);

> > and Remeron (mirtazapine).

> >

> > [March 22, 2004 Public Health Advisory - FDA]

> > [March 22, 2004 Drug Information Page - FDA]

> >

> > Return to Top | MedWatch Home | MedWatch Safety Info | Online

> > MedWatch Report | Contact Medwatch

> >

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> --

> > -----------

> >

> > Faaborg Patient Lifts

> > Audience: Hospital and nursing home administrators and risk

> managers

> > The FDA notified healthcare professionals of a Class I recall of

> > Faaborg battery operated patient lifts distributed by Moving

> > Solutions, Inc., of Downers Grove, Ill., because of a faulty

> design.

> > Excessive wear of the main bolt, which secures the lift arm to the

> > main frame of the patient lift, will cause the bolt to break which

> > will cause the patient to fall and could result in serious injury,

> > even death. FDA has received one report of death related to the

> > failure of the bolt. Facilities should stop using these lifts

> until

> > the problem is corrected.

> >

> > [March 09, 2004 Recall Notice - FDA]

> > [March 09, 2004 Press Release - FDA]

> >

> > Return to Top | MedWatch Home | MedWatch Safety Info | Online

> > MedWatch Report | Contact Medwatch

> >

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> --

> > -----------

> >

> > Duragesic (fentanyl transdermal system)

> > Audience: Pharmacists, other healthcare professionals, and

> consumers

> > (February 20, 2004) Janssen Pharmaceutica and FDA notified

> > healthcare professionals of a Class I recall of DURAGESIC 75

> mcg/h.

> > Only Control Number 0327192 (expiration October 2005) is subject

> to

> > this recall. A potential seal breach on one edge may allow drug to

> > leak from the patch and could result in an increased absorption of

> > the opioid component, fentanyl, leading to increased drug effect,

> > including nausea, sedation, drowsiness, or potentially life

> > threatening complications. Conversely, if the hydrogel contents

> leak

> > out of the patch, there may not be adequate medication to treat

> the

> > patients' pain. In an opioid tolerant patient, this may lead to

> > withdrawal symptoms, which include sweating, sleeplessness and

> > abdominal discomfort.

> >

> > (UPDATE April 9, 2004) Janssen expanded its US recall to include 5

> > manufacturing lots. See updated information below.

> >

> > [uPDATE April 7, 2004 Pharmacist Recall Notification - Janssen]

> > [uPDATE April 2, 2004 Dear Health Care Professional Letter -

> > Janssen]

> > [February 17, 2004 Recall Notice - Janssen]

> > [February 17, 2004 Product Photos - Janssen]

> > [February 16, 2004 Patient and Caregiver Information - Janssen]

> >

> > Return to Top | MedWatch Home | MedWatch Safety Info | Online

> > MedWatch Report | Contact Medwatch

> >

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> --

> > -----------

> >

> > Counterfeit contraceptive patches

> > Audience: Reproductive healthcare professionals and consumers

> > FDA and and Co. of Raritan, NJ are warning the

> > public about an overseas internet site selling counterfeit

> > contraceptive patches that contain no active ingredients.The

> > counterfeit contraceptive patches were promoted as Ortho Evra

> > transdermal patches, which are FDA approved, and made by

> and

> > 's Ortho-McNeil Pharmaceutical, Inc. subsidiary. These

> > counterfeit patches provide no protection against pregnancy.

> > Consumers who have any of these products should not use them, but

> > instead contact their healthcare providers immediately.

> >

> > [February 4, 2004 Talk Paper - FDA]

> >

> > Return to Top | MedWatch Home | MedWatch Safety Info | Online

> > MedWatch Report | Contact Medwatch

> >

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> --

> > -----------

> >

> > Viramune (nevirapine)

> > Audience: Infectious disease and other healthcare professionals

> > Boehringer Ingelheim and FDA notified healthcare professionals of

> > new safety information added to the WARNINGS and Boxed Warning for

> > VIRAMUNE. Severe, life-threatening, and in some cases fatal

> > hepatotoxicity, including fulminant and cholestatic hepatitis,

> > hepatic necrosis and hepatic failure, has been reported in

> patients

> > treated with VIRAMUNE. These events are often associated with

> rash.

> > Women, and patients with higher CD4 counts, are at increased risk

> of

> > these hepatic events. Women with CD4 counts >250 cells/mm3,

> > including pregnant women receiving chronic treatment for HIV

> > infection, are at considerably higher risk of these events.

> > Prodromal signs and symptoms, risk information and monitoring

> > recommendations have been added to the labeling.

> >

> > [February 2004 Letter - Boehringer Ingelheim]

> > [February 2004 Revised label - Boehringer Ingelheim]

> > [January 2004 Guidelines: Management of Rash/Hepatic Events with

> > Viramune - Boehringer Ingelheim]

> >

> > Return to Top | MedWatch Home | MedWatch Safety Info | Online

> > MedWatch Report | Contact Medwatch

> >

-------------------------------------------------------------------

> --

> > -----------

> >

> > OTC pain and fever reducers (acetaminophen / NSAIDs)

> > Audience: Pharmacists, other healthcare professionals, and

> consumers

> > The FDA notified healthcare professionals of a national education

> > campaign to provide advice on the safe use of over-the-counter

> (OTC)

> > pain and fever reducers that contain acetaminophen and non-

> steroidal

> > anti-inflammatory drugs (NSAIDs). The campaign is intended to

> raise

> > consumer awareness of these safety issues and to inform healthcare

> > providers about the role that they can play in preventing

> > acetaminophen induced hepatotoxicity and NSAID-related

> > gastrointestinal bleeding and renal toxicity in patients using

> these

> > medicines.

> >

> > [January 22, 2004 Drug Information Page - FDA]

> > [January 22, 2004 Science Backgrounder - FDA]

> > [January 22, 2004 Letter to State Boards of Pharmacy - FDA]

> > [January 22, 2004 Press Release - FDA]

> >

> > Return to Top | MedWatch Home | MedWatch Safety Info | Online

> > MedWatch Report | Contact Medwatch

> >

-------------------------------------------------------------------

> --

> > -----------

> >

> > Antibody to HBsAg ELISA Test System 3

> > Antibody to HBsAg ELISA Test System 3 Confirmatory Test

> >

> > Audience: Blood bank and other laboratory professionals

> > Ortho-Clinical Diagnostics Inc. and FDA notified healthcare

> > professionals of reports of increased initial reactive (IR) and

> > repeat reactive (RR) rates obtained with the Antibody to HBsAg

> ELISA

> > Test System 3 donor screening assay, with false repeat reactive

> > results being confirmed using the Antibody to HBsAg ELISA Test

> > System 3 Confirmatory Test. Ortho is currently examining available

> > information as to the causes of these events. The letter

> recommended

> > measures to mitigate problems with the donor screening assay, and

> > provided changes made to the instructions for use of the Antibody

> to

> > HBsAg ELISA Test System 3 Confirmatory Test kit.

> >

> > [December 23, 2003 Letter - Ortho-Clinical Diagnostics Inc.]

> >

> > Return to Top | MedWatch Home | MedWatch Safety Info | Online

> > MedWatch Report | Contact Medwatch

> >

> > MedWatch Home | Safety Info | Submit Report | How to Report |

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> >

> > FDA/CDER/Office of Drug Safety

> > Web page last revised by jlw June 23, 2004

June 25, 2004