Drug Warning: Duragesic

Generic name: fentanyl transdermal system

Manufactured and marketed by:

Purpose: A patch prescribed for individuals who suffer from long periods of chronic pain, possibly exceeding a few weeks or longer, and who require strong pain medication around the clock. Duragesic was the first painkiller patch to receive approval.

Side Effects Reported

• Duragesic is considered a controlled substance because it contains a powerful narcotic medication and it therefore has the potential for abuse.
• The Schedule II opioid substances have the highest potential for abuse. Therefore, side effects of Duragesic may include addiction, or symptoms of physical dependency, and withdrawal, if use is stopped abruptly.
• In addition, Duragesic may cause life threatening respiratory depression, called hypoventilation. Respiratory depression has been linked to opioid agonists in general, including fentanyl.

Industry Report

The FDA has reported that they are looking into reports of death and serious side effects from the use of Duragesic. On July 15, 2005, the FDA issued a health advisory concerning the safe use of the pain patch because of reports of patients dying while using Duragesic. Deaths and overdoses have occurred in patients using Duragesic and in patients using a generic version of the patch. The FDA is looking into reports of 120 dead patients who had used painkiller patches containing fentanyl.

In February of 2004, Janssen Pharmaceutica recalled one of its lots of Duragesic pain patches because of a potential seal breach on the edge of the pain patch that may cause the drug to leak. If the drug leaks out of the patch it may cause increased absorption of the pain medication, which increases the effect of the drug.

Seeger Weiss is not currently pursuing lawsuits on this drug, but its drug warnings will remain on our radar.

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