July 19, 2005

FDA ALERT

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

FDA MedWatch - Safety Warnings Regarding Use of Fentanyl Transder mal (Skin) Patches

FDA issued a public health advisory to alert health care professionals, patients and their caregivers of reports of death and other serious side effects from overdoses of fentanyl in patients using fentanyl transdermal (skin) patches for pain control. Deaths and overdoses have occurred in patients using both the brand name product Duragesic and the generic product. Some patients and health care providers may not be fully aware of the dangers of this very strong narcotic painkiller. The directions for using the fentanyl skin patch must be followed exactly to prevent death or other serious side effects from overdosing with fentanyl.

Read the MedWatch safety summary, including links to the Public Health Advisory, Healthcare Professional and Patient Information Sheets, and the Drug Information Page at:

http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#Fentanyl