The Quick Facts on the Duragesic Patch

  • There has been an expanded recall of Duragesic Patches (fentanyl transdermal) due to possible leaks.
  • The FDA is investigating 120 deaths of Duragesic Patch users and warned patients to use the powerful narcotic properly to avoid accidental overdose.
  • Over 400,000 Duragesic Patches are included in the recall.
  • Leakage of the medication could lead to leading to potentially life-threatening complications and and/or opiate withdrawal.
  • The patches come in different strengths, and more than one patch may be worn at a time.
  • In April 2004, Janssen expanded the Duragesic patch recall to include a total of 2.2 million patches. Health officials believe that over 20 percent of the recalled patches are still in use.
  • Bounty Hunter Domino Harvey , subject of New Line Cinema’s 2005 Movie, “Domino” died of an accidental overdose from the powerful painkiller fentanyl. This drug is more powerful than morphine and her death was due to acute fentanyl toxicity.
  • Approved by the U.S. Food and Drug Administration (FDA) in 1990, Duragesic releases fentanyl, a strong opioid, through the skin at a fixed rate for 72 hours. The patch is available only by prescription.

The FDA is conducting an investigation into the deaths associated with these patches. The Agency has been examining the circumstances of product use to determine if the reported adverse events may be related to inappropriate use of the patch or factors related to the quality of the product

The FDA is working with the manufacturers of fentanyl patches to fully evaluate the risks associated with their use and to develop a plan to help patients avoid accidental fentanyl overdose.

Some patches from the recalled lots may leak medication due to improper sealing of one of their edges.

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