The FDA issues a Fentora alert

WASHINGTON, Sept. 26 (UPI) -- The U.S. Food and Drug Administration issued an alert Wednesday concerning the use of Fentora tablets to control cancer pain.

The FDA said it received reports of adverse effects, including death, linked to the use of Fentora (fentanyl buccal), a potent opioid pain medication used only for treatment of breakthrough pain in cancer patients receiving opioid treatment and who have become tolerant to it.

Breakthrough pain is intense increases in pain that occur with rapid onset. Patients who frequently take narcotic pain medications can become tolerant and are more resistant to the dangerous side effects of these medications.

The FDA said the adverse incidents reported were the result of improper selection of patients, dosing or improper product substitution.

FDA officials warned Fentora is not the same as other fentanyl products and cannot be substituted for Actiq, another fentanyl product used to treat breakthrough cancer pain. Because Fentora delivers more fentanyl to the blood than Actiq, substituting Fentora for Actiq using the same dose can result in a fatal overdose, the FDA said.

Fentora is manufactured by Cephalon Inc.

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