Its manufacturer Johnson & Johnson and Novartis AG's Sandoz voluntarily recalled patches in the U.S. and Canada that release 25 micrograms of fentanyl in an hour with expiration dates on or before December 2009.
The Duragesic patches, made by Johnson & Johnson's Alza Corp., may have a cut along the drug reservoir, exposing users directly to the fentanyl gel inside containing powerful "opioid" drug. If a person's skin comes in direct contact, he can have difficulty breathing.
The New Brunswick, New Jersey-based company said in a statement that damaged patches should be flushed down the toilet and not handled. If your skin is exposed to the gel, then it should be thoroughly rinsed with plain water and no soap should be used.
It's the fifth recall of some version of the patches since 1994. The U.S. Food and Drug Administration (FDA) put out its second warning in two years in December 2007 about the dangers of misusing the powerful drug.
Duragesic patches generated $1.16 billion in global sales last year, making them Johnson & Johnson's eighth-biggest selling product. Fentanyl is an opioid analgesic with a potency approximately eighty times that of morphine.
Fentanyls are extensively used for anesthesia and analgesia, most often in the operating room and intensive care unit. Fentanyl transdermal patch (Durogesic/Duragesic) is used in chronic pain management. Fentanyl patches work by releasing fentanyl into body fats, which then slowly release the drug into the blood stream over 72 hours, allowing for long lasting relief from pain.
PriCara estimates that two patches out of every million included in the recall have the defect that causes the leak. The recalled patches were also sold in Canada under the Duragesic brand by Janssen-Ortho Inc. and generically by Ranbaxy Laboratories Ltd.
Illicit use of pharmaceutical fentanyls first appeared in the mid-1970s in the medical community and continues in the present. United States authorities classify fentanyl as a narcotic.
To date, over 12 different analogues of fentanyl have been produced clandestinely and identified in the U.S. drug traffic. The biological effects of the fentanyls are similar to those of heroin, with the exception that many users report a noticeably less euphoric 'high' associated with the drug and stronger sedative and analgesic effects.
