Duragesic is the leading brand of a narcotic pain patch containing fentanyl, a drug under investigation by the FDA due to reports of adverse respiratory events experienced by patients wearing the patch. Affected patients experienced severe shortness of breath, fatigue, and in some cases their breathing seems to shut down entirely.

An investigation by the Los Angeles Times reported today that the Los Angeles County Coroner’s office alone has investigated more than 230 deaths involving fentanyl. Of those 230-plus cases, 127 were classified as “accidental deaths,” suggesting that the victims had inadvertently received too much of the drug through the pain patch.

Fentanyl patches * were developed for use by cancer patients, who are usually monitored closely by physicians. Increasingly, however, the Duragesic patch* is being prescribed for other conditions, sometimes without close monitoring. The LA Times report cited the case of a 76-year-old retired paralegal with severe back pain who was prescribed the patch and developed shortness of breath and severe fatigue while on the patch.

The LA Times report also cited 115 additional fentanyl deaths from the state of Florida in the year 2004, as well as an alarming rise in emergency-room cases involving the drug. According to the federal Substance Abuse and Mental Health Services Administration, emergency-room admittals involving fentanyl rose from 28 in 1998 to 1506 in 2004.

Duragesic sales have more than doubled between 2000 and 2004, with more than $1.2 billion in sales in 2004, yet reports of adverse events related to the Duragesic patch began occurring as early as 2001, less than a year after the patch was approved for sale in the U.S. The FDA did not issue a safety alert on the Duragesic patch until July 15, 2005. Currently there are more than 4 million prescriptions written for the Duragesic patch annually.

Source: Ricardo Alonso-Zaldivar, “FDA Slow to Sound Alarm on Pain Drug, ” Los Angeles Times, November 25, 2005.