February 12, 2008 – PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. announced that all lots of 25 microgram/hour (mcg/hr) DURAGESIC® (fentanyl transdermal system) CII patches sold by PriCara in the United States and all 25 mcg/hr fentanyl patches sold by Sandoz Inc. in the United States are being voluntarily recalled. The recall is being conducted in cooperation with the FDA.
The recalled pain patches all have expiration dates on or before December 2009 and are manufactured by ALZA Corporation, an affiliate of PriCara. All 25 mcg/hr fentanyl patches manufactured by ALZA and sold in Canada are also being recalled.
The recalled DURAGESIC 25 mcg/hr (fentanyl transdermal system) and Sandoz Inc. 25 mcg/hr fentanyl transdermal system patches may have a cut along one side of the drug reservoir within the patch resulting in a possible release of fentanyl gel from the gel reservoir into the pouch in which the patch is packaged.
This leak could expose patients or caregivers directly to fentanyl pain gel either causing an overdose or making the pain patch ineffective. Duragesic patches that are cut or damaged in any way should not be used as the fentanyl gel could cause diminished breathing, depression, and/or overdose which could be fatal.
This is not the first time that pain patches have been the subject of life threatening recalls. Janssen Pharmaceutica and Johnson & Johnson have both been sued from previous pain patch recalls.
In 2005, the family of a 28 year old male won a $5.5 million Duragesic pain patch settlement. It wasn’t until more than a year after this death that the first health alerts were issued for the Duragesic patch. What took so long?
In 2006 Texas jury ruled against Johnson & Johnson to pay $772,500 in actual damages to the family of a woman who died because of leakage in a pain relief patch. The victim unknowingly used two pain patches to manage the pain she incurred after a car accident. Johnson & Johnson maintained that its Duragesic pain relief patches are safe.
Meanwhile the FDA continues to investigate 120 deaths tied to pain patches made by Johnson & Johnson and Mylan Laboratories.
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