FDAnews Drug Daily Bulletin

The FDA issued a public health advisory to warn physicians about prescribing cancer pain treatment Fentora because of recent reports of deaths associated with the medication.

Fentora (fentanyl buccal), which is marketed by Cephalon, is a unique, potent opioid medication and should not be substituted for Cephalon’s cancer pain treatment Actiq (oral transmucosal fentanyl citrate), the FDA warned doctors.

Generic versions of Actiq have been available since last fall after Barr Laboratories entered into a settlement with Cephalon over the product. Cephalon has been under investigation by the Connecticut Attorney General’s Office for off-label promotion of Fentora.

The public health advisory follows an agency release of a MedWatch report and dissemination of a Dear Doctor letter by Cephalon warning physicians about the same problems with the drug.