FDA issues Public Health Advisory for Duragesic Patches

The US Food and Drug Administration (FDA) issued a public health advisory about the safe use of transdermal fentanyl patches on Friday, July 15, 2005. The alert urges patients using the product to follow directions exactly to prevent an overdose. The advisory is in response to reports of deaths in patients using the patch for pain management. The Duragesic patch contains a strong opioid medication, called fentanyl, which is delivered slowly into the body through the skin (transdermal), and usually lasts three days, which makes it convenient. It is intended to treat moderate-to-severe chronic pain, when other medicines have not been effective or well tolerated.

The FDA also issued a patient information sheet and an alert to health care professionals, which identifies several safety precautions for the use of the patches. The patient information sheet outlines

• who should or should not use fentanyl patches,
• the risks associated with using or misusing the patch,
• side effects that should be reported to your doctor,
• signs of overdose,
• proper application of the patch, and other safety information regarding the use and storage of the patches and safeguards for children.
  

The patient information sheet is available at http://www.fda.gov/cder/drug/InfoSheets/patient/FentanylPIS.pdf. The FDA stresses the need to follow the directions from your doctor and the drug manufacturer exactly to prevent overdose or other severe side effects from the medication. Visit the FDA information page on fentanyl patches at http://www.fda.gov/cder/drug/infopage/fentanyl/default.htm and the Duragesic web site at http://www.duragesic.com for more information about this treatment option and safe use of fentanyl patches.