Fentora's "Dear Doctor" Letter

Washington, DCFentora, Cephalon's new "breakthrough" pain remedy is already in trouble, barely a year since it was approved by the FDA. Cephalon also made Actiq-- a drug similar to Fentora--that was linked to hundreds of drug overdoses and even death. (Fentora and Actiq are both powerful narcotic painkillers containing fentanyl, a man-made opiate.)

Actiq was approved in 1998 for treatment of severe pain in cancer patients, but it was prescribed to thousands of people for off label treatment of non-cancer related pain. Cephalon got into trouble with Antiq when it marketed the drug to doctors other than oncologists; furthermore, the company admittedly marketed prescription drugs for off-label use - an illegal practice.

Fentora is indicated only for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their cancer pain. On September 13th, the FDA posted on its [website] a "Dear Healthcare" letter from Cephalon regarding new safety information about Fentora(fentanyl buccal tablet).

Cephalon reported that "Serious adverse events, including deaths, have occurred in patients treated with Fentora," and it then went on to blame improper patient selection, improper dosing and/or improper product substitution.

Cephalon's vice-president, Jeffrey M. Dayno, M.D., said that the drug is indicated only for the management of breakthrough pain in patients with cancer and should not be used in opioid non-tolerant patients. (Breakthrough pain (BTP) is pain that arises suddenly, unforeseen, for short periods of time, and is not alleviated by the patients' normal pain suppression management.)

Why then, has Fentora been prescribed off-label? In its "Dear Doctor" letter, Cephalon warned not to substitute Fentora for Actiq or other fentanyl-containing products, and not to prescribe the pain treatment to patients who are opioid non-tolerant, or who have acute pain, postoperative pain, headache/migraine or sports injuries. Cephalon also said in the letter that it has "revised the patient selection criteria and dosing instructions for Fentora and will be updating its package insert shortly."

For some people, "shortly" was too late.