Pharmacy Services

Fentanyl Buccal Tablet (Fentora)-Inappropriate Use Causes Death, Adverse Effects - UPDATED

September 28, 2007

The FDA and Cephalon are alerting clinicians that fentanyl buccal tablets (Fentora) may result in death or adverse events when inappropriately prescribed. These events occurred in opioid-naïve patients, and patients who received improper doses or product substitutions. Fentora is not bioequivalent to Actiq or other oral fentanyl products.

Fentora is labeled for the management of breakthrough pain in opioid-tolerant cancer patients. It is contraindicated for use in patients who are not opioid-tolerant or for other pain syndromes, such as acute pain, postoperative pain, headaches or migraines, or injury-related pain. Ensure patients use no more than 2 Fentora tablets per breakthrough pain episode and wait at least 4 hours before treating another episode. Cephalon is revising the product labeling and the Patient Medication Guide to include updated information regarding patient selection criteria and dosing instructions for Fentora.

Additional information is available at the following links:

FDA MedWatch Alert:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm152293.htm
Dear Doctor Letter:
http://www.fda.gov/downloads/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/UCM154439.pdf
Dear Healthcare Professional Letter:
http://www.fda.gov/downloads/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/UCM154443.pdf
Information for Healthcare Professionals:
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm126082.htm
FDA News Release:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm108994.htm
FDA Public Health Advisory:
http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm051273.html
Product information with medication guide:
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021947s002lbl.pdf

Please contact the Drug Information Service at 801-581-2073 if you need any further details.

Updated
September 28, 2007; September 14, 2007; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.