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. #