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Drug Information: Fentanyl Patches

Fentanyl pain patches, manufactured under the Duragesic ® Patch label or a generic fentanyl label, contain a Schedule II opioid medication for pain relief that is 80-100 times stronger than Morphine. Fentanyl was originally approved in 1990 to treat acute, postoperative and moderate-to-severe pain. Applied to the skin, the patch delivers a powerful and constant dose of fentanyl in gel form, providing pain relief for up to 3 days.

On February 17, 2004, Janssen Pharmaceutical Products, LP issued an urgent Recall Notice on the Duragesic® fentanyl patch, informing users that approximately 400,000 Duragesic® patches were defective. The manufacturing defect is a seal breach on one edge of the patch that allows direct skin contact with the powerful fentanyl drug gel that could result in overdose and potentially death.

Subsequently on July 15, 2005, the FDA issued a Public Health Advisory warning to physicians and users of all Fentanyl patches that, “deaths and overdoses have occurred in patients using both the brand name product Duragesic and the generic [fentanyl] product.” The FDA is currently investigating more than 120 deaths associated with the fentanyl patch.

The fentanyl patch, whether under the Duragesic ® label or a generic fentanyl label, has been linked to a number of severe, life-threatening, side effects such as:

– depressed respiratory function
– decreased blood pressure
– coma
– death

Immediately contact a doctor if you or a loved one has experienced any of the above side effects associated with fentanyl use.

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