FDA and the Duragesic Patch

About the Duragesic Patch

The Duragesic Patch is a pain patch that is worn on the skin as an external treatment for chronic pain. The Duragesic patch contains a narcotic analgesic called fentanyl. Duragesic releases fentanyl, a strong opioid, through the skin at a fixed rate for 72 hours. The patch is made by Janssen Pharmaceutica and available by prescription only.

The Duragesic Patch is for the management of severe, chronic pain that cannot be managed with less powerful drugs such as acetaminophen-opioid combinations and nonsteroidal analgesics. Moreover, only patients who are already on and tolerant to opioid therapy, and who require continuous opioid administration should use the patch. Approved by the U.S. Food and Drug Administration (FDA) in 1990.

FDA and the Duragesic Patch

On July 15, 2005 the FDA issued a Public Health Advisory warning regarding the use of the Duragesic patch due to recent reports of overdoses and death in those who were using the potent narcotic medication as a pain reliever.

On April 27, 2005 the FDA approved revisions to safety labeling of fentanyl transdermal systems, including Duragesic, that stated the patch is associated with a risk of serious or life-threatening hypoventilation that may occur at any time during the use of the patch.

In February 2004 , Janssen and the FDA notified healthcare professionals of a Class I recall of DURAGESIC 75 mcg/h. Only Control Number 0327192 (expiration October 2005) is subject to this recall. A potential seal breach on one edge may allow the drug to leak from the patch and could result in an increased absorption of

These safety precautions include but are not limited to patient education regarding signs of overdose, proper patch application, use of other medications while using the patch, safeguards for children, and proper storage and disposal.

The Food and Drug Administration is probing whether the deaths are related to inappropriate use of the painkiller or factors related to the product’s quality.

FDA reports suggest that some deaths have been accidental overdoses, and some reports suggest that patients or those prescribing the medication were not aware of crucial safety information on the drug’s label, said the FDA’s Robert Meyer.

The Duragesic Patches affected are from the following lot numbers:

  • NDC no. 50458-035-05
  • Lot Control #0327192
  • Lot Control #0327193
  • Lot Control #0327294
  • Lot Control #0327295
  • Lot Control #0330362

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