Medication Adverse Event Alert

September 14, 2007

MEDICATION:	Fentora® (fentanyl buccal tablet), Cephalon
DOSAGE FORM:	fentanyl buccal tablet
STRENGTHS:	100, 200, 300, 400, 600 and 800mcg fentanyl tablets
ISSUE:	Fentora and the occurrence of serious adverse events including deaths as a result of improper patient selection, dosing, and/or product substitution

The following was posted on the FDA News web site on September 13, 2007:

"Cephalon issued two Dear Healthcare Professional Letters to inform prescribers and other healthcare providers of important safety information regarding Fentora. Fentora is indicated only for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Serious adverse events, including deaths, have occurred in patients treated with Fentora. These deaths occurred as a result of improper patient selection (e.g., use in opioid non-tolerant patients), improper dosing, and/or improper product substitution. The healthcare professional letters provide key points regarding appropriate patient selection and proper dosing and administration of Fentora to reduce the risk of respiratory depression"

For additional information, visit: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Fentora.