Two U.S. Drug Makers Recall Fentanyl Patches

Two U.S. pharmaceutical firms recently announced voluntary recalls involving certain opioid-containing patches they each market for pain control. The patches, which contain fentanyl, were recalled from wholesalers and pharmacies because of concerns that defects seen in some of the products could permit leakage of the contents and subsequent overdose.

Transdermal fentanyl is a Schedule II opioid indicated for the management of moderate to severe chronic pain that requires around-the-clock opioid administration for extended periods and that cannot be controlled by other means, including opioid combination products or immediate-release opioids.

PriCara, a division of Raritan, N.J.-based Ortho-McNeil-Janssen Pharmaceuticals Inc., announced on Feb. 12 that it was voluntarily recalling all lots of its 25-microgram/hour fentanyl transdermal patches, sold as DURAGESIC. Also included in this recall are all lots of 25-microgram/hour fentanyl patches sold by Sandoz Inc. All of the patches were manufactured by PriCara affiliate ALZA Corp. and carry expiration dates on or before December 2009.

The patches were recalled from wholesalers and pharmacies as a precaution when it was discovered they might have a cut along one side of the drug reservoir that could allow the gel contents to leak and pose a potential exposure hazard. Such direct exposure to the fentanyl gel contained in the patches could result in serious adverse events, such as severe respiratory depression and even death from overdose.

Five days later, Actavis Inc., based in Morristown, N.J., announced it also was voluntarily recalling 14 lots of its fentanyl transdermal patches -- in 25-, 50-, 75- and 100-microgram/hour strengths -- from product wholesalers and pharmacies. Actavis cited the same concerns about possible drug leakage and exposure in announcing its recall.

A Feb. 17 press release includes the affected lot numbers.

The Actavis patches were manufactured by Corium International Inc. and sold in the United States by Actavis South Atlantic LLC. It's important to note that Actavis South Atlantic was formerly known as Abrika Pharmaceuticals, so the pouches containing the patches carry the Abrika Pharmaceuticals label, although the outer carton bears the Actavis logo.

In each of the two recall announcements, patients are advised to immediately dispose of affected patches that may be damaged or compromised in any way by flushing them down the toilet, using caution not to handle them directly. Damaged patches that have leaked their gel contents will not provide effective pain relief. Patients who come in contact with any leaked fentanyl gel should thoroughly rinse the exposed skin with copious amounts of water only; soap should not be used.

Physicians are encouraged to report problems associated with use of these products to MedWatch, the FDA Safety Information and Adverse Event Reporting Program. Contact MedWatch by phone at (800) FDA-1088 or through the MedWatch Web site.