Fentanyl painkillers were recalled because of a flaw that could cause patients or caregivers to overdose on the potent drug inside, media reported on Wednesday.
Sold in the United States under the brand name Duragesic by PriCara and generically by Sandoz Inc., the recall includes all patches with expiration dates on or before December 2009.
The drugs are stored in gel form. If the fentanyl gel leaks into packagings, it could cause people to come into direct contact with this powerful "opioid" drug. This could result in difficulty breathing and a potentially fatal overdose.
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 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 not used to this family of painkillers. Yet the FDA found cases where doctors prescribed it for headaches or post-surgical pain.
The recalled patches were also sold in Canada under the Duragesic brand by Janssen-Ortho Inc. and generically by Ranbaxy Laboratories Ltd.
(Agencies via Xinhua News Agency February 13, 2008)
