FDA Warns Physicians Against Prescribing Fentora for Off-label Uses

The FDA has issued an alert for health care professionals warning them about the use of fentanyl buccal (i.e., Fentora) tablets after recent reports of deaths and other adverse events. The FDA says the deaths were the result of improper patient selection, dosing or product substitution.

Fentora is a potent opioid pain medication that should be used only for the treatment of breakthrough pain in cancer patients who are receiving opioid treatment and who have become tolerant. Of particular interest to family physicians, the FDA warns against using Fentora for any short-term pain, such as headaches or migraines, sports injuries, or postoperative pain.

Patients who take narcotic pain medications regularly become tolerant and are more resistant to the adverse effects of these medications than patients who take narcotic pain medication less frequently. For this reason, it is critical that Fentora not be used in patients who are not opioid tolerant, according to the FDA.

The alert also points out that Fentora is not a generic version of Actiq, which is an opioid that also contains fentanyl. Because Fentora is not a generic drug, it should not be prescribed as a substitute for Actiq or any other fentanyl-containing product. Fentora delivers more fentanyl to the blood than Actiq and other drugs that contain fentanyl, so using the same dose of Fentora can result in a fatal overdose.

The FDA has asked Cephalon Inc., the manufacturer of Fentora, to strengthen warnings and improve dosing instructions on the drug's product labeling. The FDA also has asked the company to improve its education plan for prescribers and pharmacists on the proper patient selection, dosing instructions and restrictions on substituting Fentora for other products.