Public health advisory issued on the fentanyl patch

AORN Journal, Oct, 2005

The US Food and Drug Administration (FDA) has issued a public health advisory regarding the safe use of transdermal fentanyl patches in response to reports of deaths in patients using this medication for pain management, according to a July 15, 2005, news release from the FDA. The FDA also has issued a patient information sheet and an alert to health care professionals that identify several important safety precautions for the use of the patches. These safety precautions include but are not limited to patient education about overdose, proper patch application, use of other medications while using the patch, safeguards for children, and proper storage and disposal.

The FDA is investigating deaths associated with these patches to determine if the reported adverse events may be related to inappropriate use of the patch or factors related to the quality of the product. It is possible that some patients and their health care providers are not aware of the dangers and the recommendations regarding these potent narcotic medication products and their safe use. The FDA is working with the manufacturers of the patches to fully evaluate the risks associated with fentanyl patch use and develop a plan to help patients avoid accidental overdose. For more information, visit http://www.fda.gov/cder/drug/info page/fentanyl/default.htm.

FDA Issues Public Health Advisory on the Fentanyl Patch (news release, Rockville, Md: United States Food and Drug Administration, July 15, 2005) http://www.fda.gov /bbs/topics/NEWS/2005/NEW01206.html (accessed 23 Aug 2005).