Fentanyl Patch Information & Warnings

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Duragesic and generic fentanyl patches release the narcotic fentanyl in measured doses through the skin for treatment of serious chronic pain. The Duragesic patch is manufactured by Janssen Pharmaceutical Products, and generic forms are manufactured by Mylan Laboratories and Actavis Inc.

Fentanyl Pain Patch Recall Update 7/23/12: Healthcare giant Johnson & Johnson (J&J) is now recalling more than 53,000 Duragesic pain patches due to problems where crystals of fentanyl may have formed in some of the patches. Fentanyl is a potent painkiller approximately 100 times more powerful than morphine, and its accumulation into crystals in the patch has the potential to lead to overdoses and other adverse events.

What’s the problem?

The U.S. FDA issued a public advisory warning in July 2005, announcing its intention to study the safety of the patch delivery system for the narcotic fentanyl. To date, the FDA has received over 120 reports of deaths linked to the use of fentanyl patches.

Claims have been made that extreme heat increases the absorption of the medication, which can lead to fatal overdoses. There have been several recalls of both Duragesic and generic fentanyl patches. Janssen first recalled Duragesic patches in 2004 due to a faulty seal that could deliver an overdose to a patient. Two more recalls were made in 2008 for Duragesic patches marketed by PriCara and as a generic product by Sandoz Inc. Fentanyl patches manufactured by Actavis Inc. were also recalled because of possible leaks. Some of these patches may still be in circulation.

If you were prescribed Duragesic patches, make sure the patches you receive were not included in the recall. Handle all patches with protective gloves, and discuss the risks of overdose with your healthcare provider. Be aware of the signs of an overdose and what you should do if you suspect that you have been the victim of an overdose.

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