Drug Information

• Alerts
• National Drug Shortages
• RxWebLinks
• Medical Service Reps

Alerts

• Home
• Sort Alphabetically
• Sound Alike / Look Alike

Pharmacy Services

Fentanyl Transdermal Patch (Duragesic, generics) - Cautions About Safe and Appropriate Use

12/24/2007

The FDA has issued a public health advisory encouraging safe prescribing and use of the fentanyl transdermal patch. This is an update to an earlier advisory from July 2005, which was issued in response to reports of fatal overdoses with this dosage form. Despite the earlier advisory, fentanyl overdoses continue to occur, including fatalities. The most common situations resulting in overdose include use of the patch in opioid-naïve patients, or use in opioid-tolerant patients who apply more patches than prescribed, change the patch more frequently than recommended, or expose the patch to heat.

FDA recommends that patients and prescribers know the signs of fentanyl overdose. Prescribers should educate patients and caregivers about proper use of the fentanyl transdermal patch, including avoiding exposing the patch to heat sources. Prescribers should encourage patients to tell their providers about all medicines they take, in order to avoid serious drug interactions.

In addition, the FDA cautions prescribers that the fentanyl transdermal patch is indicated for the treatment of moderate to severe chronic pain in opioid-tolerant patients at least 2 years old who require the daily equivalent of at least transdermal fentanyl 25 mcg/hour. When determining the starting dose of fentanyl transdermal patch, consult the prescribing information for the appropriate conversion from another opioid analgesic. The fentanyl transdermal patch is contraindicated in intermittent pain, mild pain, or post-operative pain. Concomitant use with cytochrome P450 3A4 inhibitors may increase plasma fentanyl concentrations, increasing the risk of respiratory depression.

FDA also informed manufacturers of fentanyl transdermal patches that a Patient Medication Guide (MedGuide) must be developed for these medications. The MedGuide should be given to patients receiving the drugs to advise them of the risk and precautions that can be taken.

Additional information is available at the following links:

• MedWatch Alerts:
  • Fentanyl Transdermal, December 2007:
    http://www.fda.gov/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/ucm152289.htm
  • Duragesic, July 2005:
    http://www.fda.gov/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/ucm151138.htm  
  • Fentanyl Transdermal, July 2005:
    http://www.fda.gov/Safety/MedWatch/ SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm151196.htm
• FDA Public Health Advisories:
  • December 2007:
    http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm051257.html
  • July 2005 (provided for historical information only):
    http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm051739.htm
• Information for Health Care Providers:
  • December 2007:
    http://www.fda.gov/Drugs/DrugSafety/ PostmarketDrugSafetyInformationforPatientsandProviders/ucm125840.htm
  • July 2005 (provided for historical information only):
    http://www.fda.gov/Drugs/DrugSafety/ PostmarketDrugSafetyInformationforPatientsandProviders/ucm125844.htm
• Fentanyl Transdermal Drug Information Page:
  http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm114961.htm
• Dear Healthcare Professional letter for Duragesic:
  http://www.fda.gov/downloads/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/UCM164429.pdf
• Information for Patients:
  http://www.fda.gov/downloads/Drugs/DrugSafety/ PostmarketDrugSafetyInformationforPatientsandProviders/UCM125846.pdf
• Related Alert - Fentanyl Boxed Warnings:
  http://healthcare.utah.edu/pharmacy/alerts/100.html

The FDA requires the distribution of Medication Guides for drugs determined to be a serious and significant public health concern. This requirement applies primarily to medications dispensed in the outpatient setting (refer to Code of Federal Regulations 21CFR208.1). However, it may be appropriate to educate inpatients about the potential hazards of prescription medications, at the clinician’s discretion. The complete list of drugs that require a Medication Guide as part of the FDA-regulated product labeling is available online at: http://www.fda.gov/cder/Offices/ODS/labeling.htm.

Updated
December 24, 2007; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.