Fentanyl Patch May Cause Fatal Respiratory Depression and Death

Dan Frith

Contributor

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A public health advisory has been issued to educate healthcare professionals and patients regarding the appropriate use of fentanyl transdermal patches (Duragesic, Alza Corp and generics), the U.S. Food and Drug Administration (FDA) advised healthcare professionals this week. Despite a previous public health advisory and safety labeling changes issued in July 2005, the FDA has continued to receive reports of death and life-threatening adverse events related to fentanyl overdose.

The fentanyl skin patch is only indicated for management of persistent, moderate to severe chronic pain in opioid-tolerant patients aged 2 years and older who require a total opioid dose at least equivalent to a 25 µg/hour patch. Because of the risk for potentially fatal respiratory depression, the patch is not indicated for the management of postoperative, mild, or intermittent pain.

Patients should use the patch exactly as prescribed. Heating pads, electric blankets, saunas, heated waterbeds, hot baths, and sunbathing can increase fentanyl exposure and should be avoided.