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Faulty Fentanyl Patches Recalled

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The Associated Press

Published: February 13, 2008

WASHINGTON - Patches containing the prescription painkiller fentanyl were recalled Tuesday because of a flaw that could cause patients or caregivers to overdose on the potent drug inside.

Sold in the United States under the brand name Duragesic by PriCara and generically by Sandoz, the recall includes all 25-microgram-per-hour patches with expiration dates on or before December 2009.

Some of the patches may have a cut in the lining of the internal reservoir where the drug is stored in gel form. If the fentanyl gel leaks into the drug's packaging, it could cause a patient or caregiver to come into contact with the opioid drug. That could result in difficulty breathing and a potentially fatal overdose.

If the 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, the FDA put out its second warning in two years about the dangers of misusing the 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.
PriCara estimates that two patches out of every million included in the recall have the defect that causes the leak.

For details on Duragesic patches sold by PriCara, call 1-800-547-6446. For details on generic fentanyl patches sold by Sandoz, call 1-800-901-7236.

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