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Johnson and Johnson Recalls Pain Patch

Posted by Jane Akre
Wednesday, February 13, 2008 12:23 PM EST
Category: Major Medical, Protecting Your Family, In The Workplace
Tags: Duragesic Patch, FDA and Prescription Drugs, Defective Drugs

JNJ is recalling the 25 microgram pain patch because of a problem with leakage that could lead to an overdose

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Johnson and Johnson’s 25 microgram Duragesic Pain Patch is being voluntarily recalled because defects could lead to an accidental overdose. 

32 million of the fentanyl-containing patch are included in the recall but it is estimated that two per million- 64 in all - have the defect.

The problem is that the pain patch delivers an opiod, fentanyl, which is highly addictive, 80 times more potent than morphine. 

The defective patches have a sliced edge that could result in fentanyl gel leaking out that would deliver more than the 25-microgram-per-hour dose

Overexposure could cause breathing problems and a fatal overdose. The 25 microgram patches are sold for lower-weight patients and children who have moderate to severe chronic pain.

The Duragesic Patch is sold by Johnson and Johnson’s PriCara unit and Sandoz.  The faulty patch has an expiration date on or before December 2009.

This is not the first leakage problem for the device. When it came on the market in 2004, the 75 microgram-per-hour patch was recalled by Janssen Pharmaceutica Products because of a leak.

In 2005 the FDA issued a Public Health Advisory warning patients about fentanyl patches and the potential of leakage from a sliced edge in the pouch. The FDA also reported it had received 120 reports of deaths related to fentanyl patches.

Pain patches have had more than their share of problems in delivering other drugs as well. The Ortho Evra Birth Control Patch (a division of JNJ) has been known to deliver more of the hormone estrogen than is safe and have been linked to the development of blood clots.

In its most recent filings with the Securities and Exchange Commission, J & J reports 72 people have sued the company claiming they were injured by Duragesic.

So far there has been a $5.5 million verdict in an injury case recovered this summer.  #

 


1 Comment

Anonymous User
Posted by Del Rodriguez
Tuesday, February 19, 2008 9:10 PM EST

I am currently serving at Ft. Drum NY. I just returned from Iraq in Nov 07. I went on EML/leave on 07 March 07. I was home for three days and my father died on the 10th. Now I just recieved a call from my mother tonight and she just read me the recall on JNJ's pain patch. OH ya and just if you were wondering he had seen his doctor which prescribed him the same patch and he died that same day. I would really like to know who made this patch and why the FDA was allowing it to be prescribed if it was killing people. Be sure of this, I am a US Soldier and I WILL FIND OUT WHO IS RESPONSIBLE........If you have any other INFO...PLEASE call me 315-285-5100.
1SG Rodriguez
US Army

Comments for this article are closed.

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