Drugs
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Fentanyl Transdermal System (marketed as Duragesic) Information
The fentanyl transdermal system (patch) is used for the management of persistent, moderate to severe chronic pain in opioid-tolerant patients when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA MedWatch program, using the contact information at the bottom of this page.
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Safety Information
FDA Reminds the Public about the Potential for Life-Threatening Harm from Accidental Exposure to Fentanyl Transdermal Systems (“Patches”)
Advisory (4/18/2012)Risk Evaluation and Mitigation Strategy (REMS) for Extended-Release and Long-Acting Opioids Fentanyl Patch Can Be Deadly to Children
Consumer articleAvoiding Fatal Overdoses with Fentanyl Patches
FDA Patient Safety News videoPreventing Patient Deaths from Fentanyl Patches
FDA Patient Safety News videoErrors Using Transdermal Patches
FDA Patient Safety News video- FDA Safe Use Initiative Letter: Invitation to help ensure the safe use and disposal of fentanyl transdermal system "patches" (PDF - 119KB)
Letter to stakeholders (3/5/2013)
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Regulatory History and Labeling from Drugs@FDA
Labels, medication guides, reviews and other information
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Historical Information
- Information for Healthcare Professionals: Fentanyl Transdermal System (marketed as Duragesic and generics) (12/21/2007 update)
FDA Public Health Advisory: Important Information for the Safe Use of Fentanyl Transdermal System (Patch)
12/21/2007FDA Issues Second Safety Warning on Fentanyl Skin Patch
FDA news release (12/21/2007)- Drug Safety Podcast: Fentanyl Transdermal System (Patch) (marketed as Duragesic and generics)
12/21/2007 Safety Warnings Regarding Use of Fentanyl Transdermal (Skin) Patches
Public Health Advisory (7/2005)Information for Healthcare Professionals: Fentanyl Transdermal System (marketed as Duragesic and generics) (07/15/05) FDA Issues Public Health Advisory on the Fentanyl Patch
FDA news release (7/15/2005)Duragesic (fentanyl transdermal system)
MedWatch Alert (7/8/2005)
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More Information
Disposal of Unused Medicines: What You Should Know Medication Disposal: Questions and Answers How to Dispose of Unused Medicines
Consumer articleDEA Nationwide Prescription Drug Take-Back Initiative Proper disposal of fentanyl patches is critical to prevent accidental exposure 
The Institute for Safe Medication Practices National Alert Network (NAN) Alert (4/25/2012)CDER Takes Steps to End Prescription Pain Medicine Misuse, Abuse, and Addiction
Consumer articleFDA Works to Reduce Risk of Opioid Pain Relievers
Consumer article
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