Fentanyl Transdermal System (marketed as Duragesic) Information

FDA ALERT 7/15/2005; Update 12/21/2007: This update highlights important information on appropriate prescribing, dose selection, and the safe use of the fentanyl transdermal system.

In July 2005, FDA issued a Public Health Advisory and Information for Healthcare Professionals that emphasized the appropriate and safe use of the fentanyl transdermal system (fentanyl patch), marketed as Duragesic and generics). Despite these efforts FDA has continued to receive reports of death and life-threatening adverse events related to fentanyl overdose that have occurred when the fentanyl patch was used to treat pain in opioid-naïve patients and when opioid-tolerant patients have applied more patches than prescribed, changed the patch too frequently, and exposed the patch to a heat source.

The fentanyl patch is only indicated for use in patients with persistent, moderate to severe chronic pain who have been taking a regular, daily, around-the-clock narcotic pain medicine for longer than a week and are considered to be opioid-tolerant. Patients must avoid exposing the patch to excessive heat as this promotes the release of fentanyl from the patch and increases the absorption of fentanyl through the skin which can result in fatal overdose. The directions for prescribing and using the fentanyl patch must be followed exactly to prevent death or other serious side effects from fentanyl overdose. These directions are provided in the current prescribing information and Instructions for Applying a Fentanyl Transdermal Patch .

This information reflects FDA’s current analysis of data available concerning this drug. FDA intends to update this when additional information or analyses become available.

• Healthcare Professional Information
• Information for Healthcare Professionals (12/21/2007)
• Public Health Advisory (12/21/2007)
• Prescribing Information (Label)
• Patient Information
  • Patient Information Sheet [PDF] or [HTML]
  • Patient Package Insert

Historical Information

• Public Health Advisory (7/2005)
• Information for Healthcare Professionals (7/2005)
• FDA Statement: FDA Issues Public Health Advisory on the Fentanyl Patch (7/2005)
• MedWatch Alert (7/2005)
• Regulatory History of Fentanyl from Drugs@FDA

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