Duragesic Patch Recall

[Broknwing]

Hey,
I didn't know for sure what forum to put this in, but I figured it was important enough to put in Announcements...

My mom just called me b/c she saw a crawl on CNN about Duragesic Patches being recalled, she knows that A lot of people I talk to here use 'em so she thought I might want to pass it along. Apparently there's a flaw in them that can cause an overdose.


ETA:looking for link on new info....

[David Berg]

The recall on that notice is from 2004. Is there a new one in the news?

[Broknwing]

sorry, didn't read the date on the notice i posted...There was one on the CNN news crawl tonight...I'll try to find it...

[sjean423]

MY Mom called, to tell me it was in todays Boston Globe

WILMINGTON, Del. - Johnson & Johnson and Novartis AG's Sandoz unit recalled some patches containing the painkiller fentanyl, saying manufacturing defects may cause leaks that can lead to fatal overdose

The Duragesic patches, made by J&J's Alza Corp., may have a cut along the drug reservoir, exposing users directly to the fentanyl gel inside, the New Brunswick, N.J., company said in a statement. It's the third recall of some version of the patches since 2004.
"Perhaps the time has come for the FDA to order Johnson & Johnson to pull all versions of this product off the shelves," said Alex MacDonald, a Boston lawyer representing the families of former patch users. Juries have found that defective patches caused two deaths since lawsuits over the products began going to trial in 2006.
Yesterday's recall covers patches in the United States and Canada that release 25 micrograms of fentanyl in an hour, J&J said. The expiration dates are on or before December 2009.
Duragesic patches generated $1.16 billion in sales last year, according to Johnson & Johnson. Fentanyl is mostly used to treat cancer pain, according to the Food and Drug Administration.
The FDA issued a safety warning in December over the patches, saying improper use could cause breathing difficulties and death. That followed a July 2005 alert put out by the FDA after 120 patients taking the drug died.
© Copyright 2008 Globe Newspaper Company.

[duge]

So I take it that they are the 25Mcg patches? I use the 50 Mcg so I should be ok....

[sjean423]

Yes, just the 25mcg. There is more info on the link, but here is a snip from WebMd. (It kind of makes it clear that the sandoz generic are made by the same manufactirer as the name brand Duragesic .....)

http://www.webmd.com/pain-management...patch-recalled

Feb. 13, 2008 -- Certain prescription skin patches containing the painkiller fentanyl are being recalled because of possible overdose risk.
The voluntary recall applies to the following products with an expiration date on or before December 2009:

• Duragesic pain patch sold by PriCara in the U.S. in the 25 mcg/hr (micrograms per hour) strength
• Generic fentanyl patches sold in the U.S. by Sandoz in the 25 mcg/hr strength
• 25 mcg/hr fentanyl patches made by Alza Corp. and sold in Canada.

Duragesic and fentanyl patches in other strengths aren't being recalled.
All of the recalled patches were made by Alza Corp., an affiliate of PriCara, which is a division of Ortho-McNeil-Janssen Pharmaceuticals. PriCara announced the recalls in a news release.

[MsRiddle]

Hi everyone~
I'm new here and this is my first post. I have been using the Duragesic Patch for four years. When I first started using them, I used 25 mcg that were produced by Jansen. I remained on that dose for a little over a year and then had to go to 50 mcg. The patch doubled in size and was much more difficult to adhere. It is recommended to use on fatty areas of your body but, unfortunately, I don't have many of those kinds of areas.

I had several overdose experiences with this product and experienced about five recalls. I continued to use it becuase it provides superior pain relief without making me feel altered. I was relieved when another, generic, product became available. It is manufactured by Mylan and is completely different than the Jansen or Sandoz product. There is no gel resivoir. The medication is in the adhesive. I am now on a 75 mcg dose and the size of the patch does not change. It is smaller than the 25 mcg gel products and it adheres very well.

I recently had a change in my insurance plan and have to obtain my medication by mail. The only product available by the mail order company is Sandoz. The 75 mcg patch is three times as big as the Mylan patch and I am afraid to use it. So I pay $20 per month to purchase the Mylan product at the retail pharmacy instead of getting a three month supply for $20.

I do hope that this recall will force Jansen and Sandoz to change to the new technology being used by Mylan. They will probably have to wait until Mylan's patent expires, but hopefully, I can use this info to try to force my mail order pharmacy to give me Mylan products instead of Sandoz.

I know that this is a long post so I'll apologize if I must. I have a hard time cutting things short but I hope that this info is helpful to someone out there.

Best wishes to all.