Deaths Linked to Drug for Breakthrough Cancer Pain Prompt Warning

ROCKVILLE, Md., Sept. 13 -- Adverse events including deaths have been linked to Fentora, a drug for breakthrough pain in cancer patients who are opioid tolerant, according to the FDA.

Cephalon, maker of the fentanyl buccal tablets marketed as Fentora, has issued letters warning physicians of the risks and outlining a strict set of recommendations for the drug's use.

According to the FDA the deaths occurred as "a result of improper patient selection (e.g. use in opioid non-tolerant patients), improper dosing, and/or improper product selection."

The drug is indicated only for the management of breakthrough pain in patients with cancer in persistent pain who are already receiving and who are tolerant to opioid therapy.

In the letters, Jeffrey M. Dayno, M.D., vice-president of medical services at Cephalon, issued these warnings:

• Do not use Fentora in opioid non-tolerant patients
• Use Fentora only for labeled indications.
• Do not prescribe the drug for patients with acute pain, postoperative pain, headache/migraine, or sports injuries.
• Be aware that Fentora is not a generic version of Actiq, therefore do not substitute Fentora for Actiq or other fentanyl-containing produces.

Dr. Dayno also advised physicians to carefully follow these dosing directions:

• For unrelieved breakthrough pain, patients should not take more than two Fentora tablets per episode.
• Patients must wait at lease four hours before treating another breakthrough pain episode with Fentora.