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Voluntary Recall Issued for Fentanyl Patches

Two manufacturers of the analgesic skin patch — the fentanyl CII patches — issued voluntary recalls of the product in February and March. When contacted by Neurology Today, company representatives at both manufacturers — Actavis for fentanyl and PriCara for Duragesic — offered no details about specific events that led to the recall, but said the recall was precautionary.

Actavis spokesperson Hjördís Arnadottir explained that some of the patches might have a fold-over defect that causes the patch to leak, and direct exposure to the fentanyl gel could lead to serious adverse events, including respiratory depression and overdose.

The PriCara patches could contain a slightly different defect: a cut in the lining where the fentanyl gel is stored, which is visible on opening the sealed foil pouch.

Actavis was unaware of “anyone being affected by a gel leak before the recall was issued,” Arnadottir said in an e-mail message.

Actavis issued their recall to include lots in 25, 50, 75, and 100 mcg/hr doses with expiration dates between May 2009 and December 2009. PriCare recalled only 25 mcg/hr patches with an expiration date of December 2009 or before; the recall includes all generic 25 mcg/hr fentanyl patches sold by Sandoz Inc., because all are manufactured by ALZA Corporation, an affiliate of PriCara.

FDA spokesperson Karen Mahoney confirmed that the companies initiated the recalls “based on the potential for a serious adverse event with exposure to fentanyl-containing gel, not because there have been any actual cases.”

“We don't have an exact count of reports of complaints about the leaks for either the Actavis or PriCara product, but the companies have done reviews,” she said. “The FDA has not found any reports of serious adverse events due to leaks related to these two recalls.”

The fentanyl patch is used to treat persistent, moderate-to-severe pain in opioid-tolerant patients — those who need continuous, around-the-clock narcotic pain medication for an extended time period. Fentanyl patches are only intended for patients whose pain cannot be managed by non-steroidal analgesics, opioid combination products, or short-acting narcotics, and should not be administered for occasional pain, headaches, or acute pain following surgery.

Charles E. Argoff, MD, assistant professor of neurology at New York University School of Medicine and director of the Neurology Pain Management Center at North Shore University Hospital in Manhasset, NY, said that the patch could be used to treat intractable pain associated with migraine, diabetic neuropathy, post-herpetic neuralgia, and multiple sclerosis. “While I am certain that many neurologists prescribe it, I am equally certain that many neurologists have limited experience prescribing it as well,” he said.

However, the recall is only a temporary setback, Dr. Argoff said, adding he'll continue to prescribe the patch for appropriate patients assuming additional safety issues do not emerge.

Fentanyl patches sold by Actavis in Europe and by PriCara in Europe, Latin America, and Asia are not affected by this recall.