FDA Issued Second Safety Warning on Fentanyl Skin Patch

Filed in archive Cancer , Consumer Alert , News , Pain Management on December 25, 2007

The Fentanyl Skin Patch is a transdermal system, an adhesive patch that delivers a potent pain medicine through the skin.

Containing the opioid fentanyl (a potent narcotic) was approved by the FDA in 1990 for use in patients with persistent, moderate-to-severe pain who have become opioid tolerant (those that have been using another strong opioid narcotic pain medicine around-the-clock, and have been using the medicine regularly for a week or longer).

Now, the FDA has recently issued its second safety warning (on deaths and serious injuries from improper use) about the fentanyl transdermal system (the first one in July 2005):

"...the directions on the product label and on the patient package insert should be followed exactly in order to avoid overdose.

FDA has continued to receive reports of deaths and life-threatening side effects after doctors have inappropriately prescribed the patch or patients have incorrectly used it.

In addition, the agency is asking manufacturers of all fentanyl patches to update their product information and to develop a medication guide for patients."

Fentanyl skin patch is most commonly prescribed for patients with cancer and is marketed under the brand name Duragesic by Johnson and Johnson while the generic versions are sold by other manufacturers.

Find more details from the FDA News.

[Photo Credit: drugs.com]