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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.
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Date created: September 26, 2007 |
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