Tuesday, February 26, 2008

Fentanyl patches recalled over leakage risk

20-Feb-2008 - Concerns have been building across North America about the safety of transdermal patches for delivering the highly potent narcotic analgesic fentanyl.
Both brand-name and generic companies selling fentanyl patches have recalled some of their products voluntarily due to the risk of a potentially life-threatening manufacturing defect.The problems emerged last week when PriCara, a division of Ortho-McNeil-Janssen Pharmaceuticals, said all lots of 25 microgram/hour (mcg/hr) Duragesic (fentanyl transdermal system) CII patches sold by PriCara in the US, as well as all 25 mcg/hr fentanyl patches sold as an authorised generic by Sandoz in the same market, were being recalled voluntarily "as a precaution" from wholesalers and pharmacies. The action was taken in co-operation with the US Food and Drug Administration (FDA). The patches involved all had expiry dates of December 2009 or earlier and were all manufactured by Alza, the drug delivery specialist that, like PriCara, is part of the Johnson & Johnson group. All 25 mcg fentanyl patches manufactured by Alza and sold in Canada - by both Janssen-Ortho as Duragesic and by Ranbaxy as Ran Fentanyl Transdermal System patches, under an October 2006 licensing and supply agreement between Janssen-Ortho and Ranbaxy Pharmaceuticals Canada - were also taken off the market. The Canadian regulatory authority, Health Canada, issued a public health advisory warning against use of the affected patches.As PriCara explained, the patches concerned "may have a cut along one side of the drug reservoir". That meant there was a possibility the fentanyl gel could be released from the gel reservoir into the pouch in which the patch is packaged, "exposing patients or caregivers to fentanyl gel". As the company pointed out, fentanyl is a powerful opioid compound classified under Schedule II of the US Controlled Substances Act. Exposure to fentanyl gel "may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal", it warned. Nor would patches with a cut edge that had leaked gel provide effective pain relief, PriCara noted. This is not the first time Johnson & Johnson has run into difficulties with Duragesic. There have been a number of recalls of the patch since it was originally approved in the US in August 1990, although PriCara spokesman Greg Panico said these involved different manufacturing issues from those behind the current recall.
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