Pain Patch Recall
On February 12, 2008, Duragesic pain patches were recalled due to a defect that could cause patients or caregivers to overdose from Fentanyl, the extremely dangerous drug found inside the patches. This recall includes all 25-microgram-per-hour patches with expiration dates on or prior to December 2009.
A number of the patches may have a cut in the lining of the internal reservoir where the drug is stored in a gel form. If the fentanyl gel seeps out into the drug’s packaging, it could cause a patient or caregiver to come into direct contact with this powerful “opioid” drug. This could result in difficulty breathing and a potentially fatal overdose.
If this reservoir is cut, it can be seen when the foil pouch containing an individual patch is opened. Damaged patches should be flushed down the toilet and not handled. Skin that has been exposed to the gel should be thoroughly rinsed with water, but not washed with soap.
In December 2007, the FDA put out its second warning in two years warning about the dangers of misusing the powerful drug. The drug is intended for chronic pain in people used to narcotics, such as cancer patients, and can cause trouble breathing in people new to this family of “opioid” painkillers. Yet the FDA found cases where doctors prescribed it for headaches or post-surgical pain.
It is estimated that approximately every two patches out of every million included in the recall have the defect that causes the leak. Ranbaxy Laboratories Ltd also sold the recalled patches in Canada under the Duragesic brand by Janssen-Ortho Inc. and generically.
All of the patches were manufacture by PriCara affiliate ALZA Corp. PriCara is a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.