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Fentanyl prescription patches were recalled for the second time in a week. The motive is a flaw that could cause patients or caregivers to overdose on the potent drug inside, and products recalled are manufactured by Actavis South Atlantic LLC which may appear under its former name Abrika Pharmaceuticals Inc. on the packaging.
The company announced that 14 lots of the patches sold nationwide might have a fold-over defect. The dosages are 25-microgram-per-hour, 50-microgram-per-hour, 75 microgram-per-hour and 100 microgram-per-hour. The patches have expiration dates of May through August 2009. The recalled patches were manufactured by Corium International Inc., a contract manufacturer for Actavis.
Last week, Johnson & Johnson and Novartis AG’s Sandoz are voluntarily recalled a version of its blockbuster pain patch Duragesic, also containing fentanyl, after manufacturers said that certain defects may cause leaks that can lead to fatal overdoses. Those recalled patches, manufactured by Alza Corp. and sold by PriCara and Sandoz Inc. in the U.S. and Canada, have expiration dates on or before December 2009. They may have an opening which could result in release of the gel made of the drug fentanyl inside.
Fentanyl is an opioid analgesic, first synthesized by Janssen Pharmaceutica (Belgium) in the late 1950s. However, the pharmacodynamics of fentanyl are still poorly understood and there is no accurate data on the pharmacodynamics in the elderly, cachectic or debilitated patients. Unfortunately, these are frequently the types of patients for which transdermal fentanyl is being used.
Transdermal fentanyl patches are also sold on the black market as the effects of the fentanyls are similar to those of heroin, with a noticeably less euphoric 'high'. However, non-medical use of fentanyl by individuals without opiate tolerance is very dangerous and has resulted in numerous deaths.
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