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What is Duragesic? Duragesic (fentanyl transdermal system) is a skin patch that belongs to a group of medicines called narcotic analgesics or opioid analgesics. Narcotic analgesics are used to relieve pain. Duragesic's skin patch form is used to treat around-the-clock pain (chronic pain) that is moderate to severe, and expected to last for weeks or longer. The Duragesic CII Patch is manufactured by ALZA Corporation and distributed by Janssen Pharmaceutica Products, L.P. Duragesic was first approved by the U.S. Food and Drug Administration (FDA) in 1990. Fentanyl Patches Recalled On February 12, 2008, painkiller patches containing the prescription medication fentanyl were recalled, because a cut in the patch's drug reservoir may cause a harmful overdose of the potent painkiller. The affected patches are sold by PriCara under the Duragesic brand name. A generic version of the fentanyl patches is marketed by Sandoz Inc. The recall applies to all 25 microgram/hour fentanyl patches (brand name and generic) with expiration dates on or before December 2009. Duragesic FDA Alert - Narcotic Overdose and Death In July 2005, the FDA issued an alert stating that it is looking into reports of death and other serious side effects from overdoses of the narcotic fentanyl in patients using Duragesic skin patches for pain control. Directions for using the Duragesic skin patch must be followed exactly to prevent death or other severe side effects that can happen from using too much (overdosing) fentanyl. These directions are provided in the patient package insert [PDF] from the FDA. |
