Re: FW: URGENT: Janssen Pharmaceutica Expands Patch Recall

[Guest guest]

These patches are being used by my mom and Dylan. They both have these lot

numbers and the pharmacy have no more, so I guess my day is going to be trying

to figure this out. They are both due to change their patches today. Thanks for

the post Laxity. Both of them have been feeling worse than usual, maybe this is

why. Cindylouwho

FW: URGENT: Janssen Pharmaceutica Expands Patch Recall

http://www.painfoundation.org/enews0404/duragesic0404.htm

URGENT: EXPANDED PRODUCT RECALL

JANSSEN PHARMACEUTICA EXPANDS NATIONWIDE RECALL OF 75 MCG/HOUR DURAGESIC®

(FENTANYL TRANSDERMAL SYSTEM) CII PATCHES

TITUSVILLE, NJ, April 5, 2004 -Janssen Pharmaceutica Products, L.P., is

expanding its U.S. recall of DURAGESIC® (fentanyl transdermal system) CII 75

mcg/hour patches to include five manufacturing lots (control numbers

0327192, 0327193, 0327294, 0327295, and 0330362). No other dosage strengths

or control numbers are affected. Available by prescription only, DURAGESIC

patches contain a potent opiate medication. (For more detailed information,

see www.Duragesic.com http://www.duragesic.com/> .)

The company recalled one lot of DURAGESIC 75 mcg/hour patches (control

number 0327192) in February 2004 after determining that some patches in this

lot might leak medication along one edge. Since then, patches with the same

problem have been identified in one additional lot. 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.

DURAGESIC patches contain a strong opiate in the form of a gel. If the gel

leaks from the patch, patients can get either too much or too little

medication. Exposure to too much medication can occur if the gel leaks

directly onto the skin and the body absorbs a higher than intended amount or

if any of the medication is swallowed accidentally. This overexposure may

cause potentially life-threatening complications. If the drug leaks out,

there may not be enough medicine to achieve the desired effect and the

patient may experience withdrawal symptoms.

The gel should not be touched if it leaks from a DURAGESIC patch. If a

patient or caregiver has unintended contact with the gel, they should

immediately wash the affected area with large amounts of water only; soap

should not be used. Patients should speak with their pharmacist or physician

for further instructions. 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. Those who have patches from lots

with control numbers 0327192, 0327193, 0327294, 0327295, and 0330362 must

contact their physician or pharmacist immediately for specific instructions

on returning patches from recalled lots and obtaining a new supply. Patients

wearing other dosage strengths or DURAGESIC patches that are not from the

recalled lots can continue to wear them. Sudden discontinuation of DURAGESIC

can cause serious health problems. The affected lots were shipped only to

distributors in the U.S. between mid-December 2003 and early March 2004.

Based on historic usage rates, the company estimates that the majority of

patches in these lots already have been used. The company has consulted

closely with the U.S. Food and Drug Administration on this expanded recall

as well as the initial recall of DURAGESIC 75 mcg/hour patches in February

2004.

DURAGESIC patches are available in four dosage strengths - 25 mcg/hour, 50

mcg/hour, 75 mcg/hour and 100 mcg/hour. Only DURAGESIC 75 mcg/hour patches

from lots with control numbers 0327192, 0327193, 0327294, 0327295, and

0330362 are affected by this expanded recall. No other lots of the 75

mcg/hour patches are affected. No other dosage strengths are affected.

Patients, caregivers and health care professionals can further the

understanding of adverse events and product defects relating to DURAGESIC by

reporting all cases to Janssen Pharmaceutica Products, L.P. at the number

listed below 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/

http://www.accessdata.fda.gov/scripts/medwatch/> .

Janssen Pharmaceutica Products, L.P., is committed to the integrity of its

products and the health and safety of the patients who use its products. For

information on this product recall, please visit www.Duragesic.com

http://www.duragesic.com/> or www.Janssen.com http://www.janssen.com/> .

The Web sites contain written material and photos of the carton and foil

pouch illustrating the location of the control number. For those without

Internet access or to report an adverse event, please call 1-800-JANSSEN

(1-).

Please see attached full prescribing information, including Boxed Warning.

Copyright 2002-2003 American Pain Foundation

To learn more about EDS, visit our website: http://members.rogers.com/ceda2/

[Guest guest]

Oh geeze Cindy!

Thanks God you found out. I can't beleive the pharmacy didn't contact you! You

better ask them why they haven't. That's pretty bad.

Hope you can get this sorted today. What a mess.

Big Hugs,

[Guest guest]

Oh geeze Cindy!

Thanks God you found out. I can't beleive the pharmacy didn't contact you! You

better ask them why they haven't. That's pretty bad.

Hope you can get this sorted today. What a mess.

Big Hugs,

[Guest guest]

From: @ Home To: ceda

Sent: Thursday, April 08, 2004 6:15 PM

Subject: Re: FW: URGENT: Janssen Pharmaceutica Expands Patch Recall

Oh geeze Cindy!

I can't beleive the pharmacy didn't contact you!

***************************************************

Apparently they had no plans to tell us. When I called Walgreen's, The

pharmacist just asked how I find out. This guy knows me by my first name,

you'd think they'd let us know. Mom's pharmacy is a small neighborhood place

that knows everyone, they didn't bother either. The pain Dr knew, he didn't

call. Moms Dr knew too. Looks like we're on our own to stick together on this

stuff. Thank you Laxity, again, for posting this. Dylan did go up to the 100mg,

but mom is still using the recalled 75's. Her Dr refuses to let her go up in

dose, and wants to bring her down to 50. Mom hurts too much to get up to go to

the Dr. I wish she'd change Drs. We should know by tomorrow if Dylan is going to

have better pain control.

Cindylouwho

[Guest guest]

That's absolutely outrageous!

I can't believe the pharmacy wouldn't tell you. It is beyond my comprehension.

I think it's absolutely unacceptable that they wouldn't call everyone on that

patch when the drug company put out the recall.

[Guest guest]

That's absolutely outrageous!

I can't believe the pharmacy wouldn't tell you. It is beyond my comprehension.

I think it's absolutely unacceptable that they wouldn't call everyone on that

patch when the drug company put out the recall.

[Guest guest]

From: @ Home To: ceda

Subject: Re: FW: URGENT: Janssen Pharmaceutica Expands Patch Recall

That's absolutely outrageous!

I can't believe the pharmacy wouldn't tell you. It is beyond my

comprehension.

I think it's absolutely unacceptable that they wouldn't call everyone on that

patch when the drug company put out the recall.

******************************************

Yes, it angers me to think they didn't take the time to call. The recall

notice on the web site, told them to do call everyone. Laxity posted this 4 days

after the recall. I would think, the pharmacy had this info before that. They

are always to busy. I suppose that would be their lousy excuse.

I'll be going to the Drs with mom on Monday to get into it with her Dr.

Mom has suffered in pain long enough! My mom has to see that this Dr is

covering her own butt and does don't have moms best interest in mind. This Dr is

afraid to RX Vicodin for chronic pain, Gezzzz. This Dr has to go.

Cindylouwho