Cephalon Warns Prescribers About Its Painkiller Fentora

Following deaths and other serious adverse events among patients taking the narcotic painkiller Fentora, the manufacturer, Cephalon, sent letters Sept. 10 warning healthcare providers to use appropriate patient selection, dosing and administration when prescribing the drug. The company said the deaths and serious adverse events occurred in patients who were not appropriate candidates for the drug.

According to the FDA’s MedWatch site, “These deaths occurred as a result of improper patient selection (e.g., use in opioid nontolerant 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 (fentanyl buccal tablet) to reduce the risk of respiratory depression.”

However, Cephalon is being investigated for off-label promotion of the drug by the Connecticut Attorney General’s Office, which said Sept. 13, “Today’s report by Cephalon tragically confirms concerns raised by our aggressive investigation into Cephalon’s off-label marketing of its drugs. News of confirmed deaths and other adverse reactions adds urgency and immediacy to our active and ongoing investigation. Our serious and significant concerns about this drug, already substantiated by evidence, are likely to support efforts for remedial action. … Our investigation is continuing vigorously, and we expect to announce the results of our findings in the near future.”

Cephalon’s letters to healthcare providers can be viewed via the MedWatch website at www.fda.gov/medwatch/safety/2007/safety07.htm#Fentora.