DuragesicR Urgent Expanded Recall Notice

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Duragesic® Urgent

Expanded Recall Notice

http://www.duragesic.com/potential/recall_consumer.jsp

URGENT EXPANDED

RECALL NOTICE

KEY INFORMATION FOR

PATIENTS AND CAREGIVERS

UPDATED April 4, 2004

About the expanded

recall...

* Janssen

Pharmaceutica Products, L.P. is expanding its nationwide

recall of Duragesic®

( Fentanyl Transdermal System) CII 75 mcg/hour

patches to include a

total of five lots, control numbers 0327192,

0327193, 0327294,

0327295, and 0330362.

o In February 2004,

one lot of Duragesic® 75 mcg/hour patches

was recalled due to

a potential leak in the product seal in a small

percentage of

patches in that lot (control number 0327192). Since then,

a small number of

patches with the same defect have been identified in

one other lot.

o As a precaution,

the company is recalling four additional

lots of 75 mcg/hour

patches that were produced on the same manufacturing

line during the same

period (0327192, 0327193, 0327294, 0327295, and

0330362).

o No other dosage

strengths or control numbers are affected.

* The company is

working closely with the U.S. Food and Drug

Administration (FDA)

and has taken steps to correct the problem and to

educate patients,

caregivers and healthcare professionals about the

situation.

* Patients or

caregivers in possession of Duragesic® 75 mcg/hour

patches should

examine the control number that appears on the bottom

flap of the outer

carton or on the back of the foil pouch.

o Those who have

patches from the recalled lots must

immediately contact

their physician or pharmacist for specific

instructions on

returning recalled patches and to obtain a new supply of

medication.

* Patients wearing

Duragesic® Patches that are not from the

recalled lots can

continue to wear them. Sudden discontinuation of

Duragesic® can cause

health problems.

About safe handling

of Duragesic® patches...

* Leakage of the gel

inside the patch has been seen rarely in other

lots of Duragesic® ,

and Janssen has taken immediate steps to correct

it. However, you

should be alert to the possibility of receiving a patch

with a leak. You

should follow the updated Duragesic® handling and

application

instructions

* The Duragesic®

patch contains a strong opiate medication in the

form of a gel. When

used normally, the medication inside the patch is

delivered slowly

into the skin through the adhesive side of the patch.

* If the medication

leaks from the patch, patients can get either

too much or too

little medication. If medication leaks directly onto the

skin or accidentally

gets in your mouth, you may be exposed to too much

medication. This

overexposure may cause potentially life-threatening

complications. If

the medication leaks out of the patch, there may not

be enough medicine

to achieve the desired effect and you may experience

withdrawal symptoms.

* If you observe

moisture or gel in the pouch containing a

Duragesic® patch, do

not use it and call your pharmacist or physician

for instructions.

Remember: do not touch the gel. Caregivers who come in

contact with any

leaked medication may have potentially life-threatening

complications.

* If you have

unintended contact with the gel, immediately wash the

affected area with

large amounts of water only; do not use soap. Speak

with your pharmacist

or physician for further instructions.

Reporting an adverse

event...

* You can help us

track adverse events relating to Duragesic® by

reporting all cases

to Janssen Pharmaceutica Products, L.P., at

1-800-JANSSEN

(1-) or to the FDA MedWatch Program by phone

(1-800-FDA-1088), by

fax (1-800-FDA-0178), by mail (using postage-paid

form to MedWatch,

FDA, 5600 Fishers Lane, Rockville, MD 20852-9787)

or

via

www.accessdata.fda.gov/scripts/medwatch/.

Frequently Asked

Questions (FAQs)

Q1. What is the

problem with the recalled Duragesic® patches?

A1. Medication may

leak from a small number of Duragesic® 75

mcg/hour patches,

from control numbers 0327192, 0327193, 0327294,

0327295, 0330362,

due to the improper sealing of one of the patch

edges.

This problem has

been seen rarely in other lots of Duragesic®

and you should be

alert to the possibility of receiving a patch

with a leak. You

should follow the updated Duragesic® handling

and application

instructions.

Q2. Has this problem

been seen with other lots?

A2. This problem has

been seen, rarely, in other lots of

Duragesic®, and

Janssen has taken immediate steps to correct it.

However, you should

be alert to the possibility of receiving a

patch with a leak.

Q3. How can I

determine if I have a patch affected by this recall?

A3. The control number

appears on both the bottom flap of the outer

carton and on the

back of each foil pouch that contains a patch. Only

Duragesic® 75

mcg/hour patches from lots with control numbers 0327192,

0327193, 0327294,

0327295, and 0330362 are affected by this expanded recall.

If you have patches

from these control numbers, you should call your

physician or

pharmacist immediately to obtain a new supply. If you

observe moisture or

gel in the pouch containing a Duragesic® patch

with any control

number, do not use it and call your pharmacist or

physician for

instructions. Remember: do not touch the gel.

Q4. What should a

patient or caregiver do if the patient is wearing

a patch from one of

the recalled lots?

A4. Anyone who has

75 mcg/hour Duragesic® patches should examine the

control number that

appears on the bottom flap of the outer carton or

back of the foil

pouch. If you have patches from lots with control

numbers 0327192,

0327193, 0327294, 0327295, and 0330362, you must

contact your

physician or pharmacist immediately for specific

instructions and to

coordinate returning affected patches and to obtain

a new supply. If you

are uncertain about whether your patch is from a

recalled lot or not,

contact your pharmacist.

Once a patch from a

new carton is available, the patch from the recalled

lot must be removed

and replaced as soon as possible. Whoever is

removing the patch

should:

* Remove the patch,

wearing rubber gloves if possible, or using

a tissue.

* Rinse their hands

and the area where the patch was applied

gently with a soft

cloth and plain water; do not use soap.

Do not rub

excessively.

* Discard the patch

according to the product disposal instructions.

Q5. What if I have a

different dosage strength of Duragesic®

or if my patches are

not from the recalled lots?

A5. Patients wearing

different dosage strengths or Duragesic®

patches that are not

from the recalled lots can continue to

wear them. Sudden

discontinuation of Duragesic® can cause

health problems.

Q6. What should I do

if I observe moisture or gel in the pouch

containing a

Duragesic® patch?

A6. Do not use the

patch and do not touch the gel. Contact your

pharmacist or

physician for instructions

Q7. What should I do

if I come into contact with the gel by mistake?

A7. If you have

unintended contact with the gel, immediately wash the

affected area with

large amounts of water only, do not use soap. Speak

with your pharmacist

or physician for further instructions. Caregivers

who come in contact

with any leaked medication may have potentially

life-threatening

complications.

Q8. Will refunds be

provided for returned patches?

A8. When a patient

presents a new prescription and unused patches

with control numbers

0327192, 0327193, 0327294, 0327295, and 0330362,

pharmacists will

exchange new patches for returned unused patches.

Depending on your

local state law, you may or may not need a new

prescription --

check with your pharmacist or physician for

instructions.

Details are being finalized to ensure that pharmacists

and patients are

reimbursed for any expenses associated with a new

prescription. Call

the Janssen Contact Center at 1-800-JANSSEN

(1-) for

specific information.

Q9. What can happen

if I use a patch that has a leak?

A9. If the

medication leaks from the patch, patients can get either too

much or too little

medication. If the medication leaks directly onto the

skin or accidentally

gets in your mouth, you may be exposed to too much

medication. This

overexposure may cause potentially life-threatening

complications. If

the medication leaks out of the patch, there may not

be enough medicine

and you may experience withdrawal symptoms.

Q10. What if I get a

rash from the leaked medication?

A10. You should

contact your physician as soon as possible.

Q11. What happens if

I have already used a patch with one of these

control numbers?

A11. If you have

worn a patch affected by this recall in the past, and

have already

discarded it, you don't need to do anything. If you have

any remaining

patches from control numbers 0327192, 0327193, 0327294,

0327295, and

0330362, you should consult your physician or pharmacist to

obtain a new supply

immediately.

Q12. What should I

do if I have remaining patches or a carton with one

of the recalled

control numbers?

A12. You must contact

your physician or pharmacist immediately to obtain

a new supply of

product. Unused, unopened patches from lots with control

numbers 0327192,

0327193, 0327294, 0327295, and 0330362 should be

immediately returned

to the pharmacist who will return the product in

accordance with

instructions from Janssen.

Q13 What if I'm

wearing a Duragesic® patch with another control number?

A13. Only 75

mcg/hour Duragesic® patches with control numbers 0327192,

0327193, 0327294,

0327295, and 0330362 should be returned to the

pharmacy as a result

of this recall. All other patches can continue to

be used. This

problem has been seen, rarely, in other lots of Duragesic®

, and you should be

alert to the possibility of receiving a patch with a

leak. You should

follow the updated Duragesic® handling and application

instructions. Sudden

discontinuation of Duragesic® can cause health

problems.

Q14. Can I wear more

than one patch (e.g., a 25 mcg/hour patch and a 50

mcg/hour patch)?

A14. While patches

of other strengths may be prescribed in combination

to replace a 75

mcg/hour patch, you need to talk to your physician about

how best to manage

your pain.

Q15. Should I be

switched to another pain medication?

A15. You need to

talk with their physician about your individual pain needs.

Q16. Where were the

recalled patches distributed?

A16. In the United

States only.

Q17. Has the

manufacturing problem been corrected?

A17. Extensive

testing to determine the cause of the problem has been

done and Janssen has

taken immediate steps to correct it.

Q18. Do my doctor

and pharmacist know about this recall?

A18. Yes. We've been

in contact with healthcare professionals,

pharmacists,

patients and caregivers since the initial problem was

identified. Our

efforts include mailings to physicians and pharmacists,

phone calls,

outreach to numerous patient and professional

organizations, and

press releases. We also are notifying all Duragesic®

distributors and

posting information on both the www.janssen.com and

www.duragesic.com

Web sites. The communications include information

about the recall as

well as updated handling and application instructions.

To apply the

Duragesic® ( Fentanyl Transdermal System)CII patch, simply

follow these steps:

PREPARE: Choose a

site to apply the patch on the chest, back, or any

flat part of the

body where there is no hair, taking care to avoid

sensitive areas or

areas of excessive movement. If there is hair, do not

shave (shaving

irritates the skin). Instead, clip hair as close to the

skin as possible.

Clean the application site with clear water only. Pat

skin completely dry.

Do not apply anything to the skin (lotions, oils,

etc) before the

patch is applied.

PEEL: Peel the liner

from the back of the patch.

PRESS: Press the

patch onto the skin with the palm of

your hand and hold

it there for at least 30

seconds, making sure

it sticks well,

particularly at the

edges.

That's all there is

to it. Use these instructions when you first apply

the patch and every

time you replace it. For more detailed instructions

on applying the

patch, see the Patient Instructions.

? Each Duragesic®

patch is sealed in its own protective pouch. Until

you are ready to use

Duragesic®, do not remove it from the pouch. When

you are ready to

apply Duragesic® Duragesic® , tear open the pouch along

the dotted line,

starting at the slit, and remove the Duragesic® patch.

* When peeling the

liner from the Duragesic® patch, avoid touching

the sticky side.

Throw away the liner.

* Do not put the

Duragesic® patch on skin that is excessively oily,

burned, broken out,

cut, irritated, or damaged in any way.

* Other recommended

places on the body to apply the patch include

the upper arm and

flank. If you have any questions about what

places on your body

you should or should not apply the patch,

please ask your

doctor.

* Not all adhesive

products stick to all patients. If the patch

does not stick well

or loosens after application, tape the edges down

with first aid tape.

In the event that the patch falls off, discard it

and put a new one on

at a different skin site.

* The Duragesic®

patch contains a strong narcotic pain medication

in the form of a

gel. If the gel should leak from the patch at any time,

do not touch the

gel. If you have unintended contact with the gel,

immediately wash the

affected area with large amounts of water only. If

you have concerns,

speak with your pharmacist or physician for further

instructions.

* Wash your hands

when you have finished applying Duragesic®

* After 3 days, or

as directed by your doctor, the Duragesic®

patch should be

removed. Then a new patch should be applied to a

different place on

the skin, repeating steps 1 through 3. Do not apply

the new patch to the

same place as the last one.

Adjusting Your Dose

of Duragesic®

If you still feel

occasional pain (what your doctor may refer to as

breakthrough pain),

you should take the breakthrough pain medication as

directed by your

doctor—it will help control your pain during these

flare-ups. Because

Duragesic® provides consistent pain control, you may

feel like doing

activities that you haven't been able to enjoy lately.

These activities can

also cause breakthrough pain, but that doesn't

always mean the

patch is not working.

Also keep in mind

that, with regular use of a medication, the body may

develop what is called

a tolerance to the medication. What this means is

that the body has

become used to the medication over time, so the same

amount may have less

of an effect than it used to. Tolerance is seen

with many

medications. It doesn't mean that the drug has lost its

effectiveness, it

just means that the dose will have to be adjusted to

achieve the right

level of relief.

It is a good idea to

keep track of how often you take pain pills for

breakthrough pain

and which activities cause you to feel breakthrough

pain. The Personal

Pain Profile is an easy way to tell your doctor which

activities are

limited by pain. Bring this information with you on your

next visit with your

doctor, so he or she can review your progress and

determine if the

dose needs to be adjusted.

How Long to Use the

Duragesic® Patch

If your pain

condition has improved, that doesn't mean you should stop

wearing the patch.

The improvement may just be a sign that Duragesic®

is working to

control your pain. You shouldn't stop any therapy unless

your doctor

instructs you to do so. If you think that you may no longer

need to wear the

patch, you should consult with your doctor, who will

help you find the

best course of action.

Back to Top

http://www.duragesic.com/potential/recall_consumer.jsp

Reporting an Adverse

Event...

You can help us

track adverse events relating to Duragesic® by

reporting all cases

to Janssen Pharmaceutica Products, L.P., at

1-800-JANSSEN

(1-) or to the FDA MedWatch Program by

phone

(1-800-FDA-1088), by fax (1-800-FDA-0178), by mail (using

postage-paid form to

MedWatch, FDA, 5600 Fishers Lane, Rockville, MD

20852-9787) or via http://www.accessdata.fda.gov/scripts/medwatch/

Read on the website

the Frequently Aksed Questions

http://www.duragesic.com/potential/recall_consumer.jsp

Hugs,

Deanna