FDA warns of Dangers of Misuse of the Duragesic Patch

New York (dbtechno) - On Friday officials issued a second warning regarding death and other dangerous side effects that have occurred using the Duragesic analgesic patch and generic versions of the patch using the drug fentanyl. The first warning was issued in July 2005.

Death and other dangerous side effects have been reported in patients who have been given this medication inappropriately to relieve mild pain in patients including post surgical pain and headaches. The warning from the FDA suggests that these patients could have been treated in a safer manner with less potent opioid medications.

Duragesic is an analgesic patch, manufactured by Johnson &Johnson, that is used to treat moderate-to-severe pain in patients who cannot tolerate opiates. The patch is applied directly to the affected area, delivering a potent narcotic transdermally.

The patch is frequently used in cancer patients according to the FDA. When the patch is used incorrectly the amounts of fentanyl in the bloodstream can reach dangerous levels. Applying heat to the patch and wearing the patch for longer than directed can increase these dangerous side effects.

The FDA warns that while the appropriate use of this medication does serve its purpose, misuse can be dangerous and life-threatening. Dr. Bob Rappaport of the FDA’s Anesthesia, Analgesia and Rheumatology Products Division states, “It is crucial that doctors prescribe these products appropriately and that patients use them correctly,”

In this warning the FDA requests that manufacturers of the Duragesic patch as well as generic forms of fentanyl patches update their safety information. They also request manufacturers highlight risks to patients in their safety information.

The FDA released its original warning in July of 2005. In this original warning FDA stated that patients need to follow directions for use and application exactly to avoid overdose. After the first warning, a decrease in inappropriate use of Fentanyl patches continued through June of 2006, according to a spokesman for Johnson & Johnson.