Drugs
Fentanyl Buccal Tablets (marketed as Fentora) Information
FDA ALERT [9/2007] - FDA has received reports of serious side effects including death in patients who have taken Fentora. These reports describe prescribing to non-opioid-tolerant patients, misunderstanding of dosing instructions, or inappropriate substitution of Fentora for Actiq by pharmacists and prescribers. The directions for using Fentora must be followed exactly to prevent death or other severe side effects from overdosing with fentanyl. FDA has asked Cephalon, the manufacturer of Fentora, to update the Fentora label and Medication Guide for patients with additional information on the safe use of Fentora.
This information reflects FDA's current analysis of data available to FDA concerning this drug. FDA intends to update this when additional information or analyses become available.
- Healthcare Professional Information
Other Information
- FDA News - FDA Warns of Potential Serious Side Effects with Breakthrough Cancer Pain Drug
- Public Health Advisory - Important Information for the Safe Use of Fentora (fentanyl buccal tablets)
- Dear Doctor Letter - Fentora (fentanyl buccal) (September 10, 2007)
- Dear Healthcare Professional Letter - Fentora (fentanyl buccal) (September 10, 2007)
Adverse reactions or quality problems experienced with the use of this Product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax, using the contact information at the bottom of this sheet.
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