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Consumer Update |
FDA issued its second safety warning on Dec. 21, 2007, about the fentanyl transdermal system, an adhesive patch that delivers a potent pain medicine through the skin. In July 2005, FDA issued a similar warning to the public and to health care providers emphasizing that 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 after people incorrectly used it.
The agency is also asking manufacturers of all fentanyl patches to update their product information and to develop a medication guide for patients. The patch is marketed as Duragesic by Johnson and Johnson, and generic versions are sold by other manufacturers.
The fentanyl skin patch contains the opioid fentanyl, a potent narcotic. The patch was approved by FDA in 1990 for use in people with persistent, moderate-to-severe pain who have become opioid-tolerant—meaning that they have been using another strong opioid narcotic pain medicine around-the-clock for a week or longer. The skin patch is most commonly prescribed for people with cancer.
Recent reports to FDA describe deaths and life-threatening side effects after health care professionals inappropriately prescribed the patch or after people used the patch incorrectly.
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Fentanyl
Date Posted: December 21, 2007
