September 13 , 2007

FDA ALERT

 

FDA MedWatch: Fentora (fentanyl buccal tablet) and the occurrence of serious adverse events, including deaths as a result of improper patient selection, improper dosing, and/or improper product substitution

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

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.

Read the complete MedWatch 2007 Safety Summary including a link to the Dear Doctor and Dear Healthcare Professional Letters and Prescribing information, at:

http://www.fda.gov/medwatch/safety/2007/safety07.htm#Fentora