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Cancer Painkiller Can Be Fatal, Manufacturer Warns

Fentora linnked to several deaths among cancer patients

September 14, 2007

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Drugmaker Cephalon has sent letters to doctors warning of serious risks with its drug Fentora, a painkiller often prescribed for cancer patients.

The letter warns doctors to carefully follow dosage guidelines after a number of deaths among patients taking the drug. The letter was issued in collaboration with the U.S. Food and Drug Administration

The company said those suffering from the reactions, including death, either took the drug improperly or weren’t candidates for it in the first place.

The letter has been sent to physicians, pharmacists, managed care organizations, and other healthcare professionals and it emphasizes the need to adhere to the Fentora prescribing information, including the following:

• 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 underlying persistent cancer pain.

• Fentora must only be prescribed to patients who are routinely taking around-the-clock opioids. Fentora should not be prescribed to patients for acute pain, postoperative pain, headache/migraine, or sports injuries.

• Only one tablet per episode should be taken once a dose is established and patients must wait at least four hours before taking another dose of FENTORA.

• Fentora is not bioequivalent to or a generic version of ACTIQ(R) (oral transmucosal fentanyl citrate) [C-II]; therefore, Fentora should not be substituted for ACTIQ or any other fentanyl-containing pain medication.

• Cephalon said it is working with the FDA to emphasize the appropriate patient selection, dosing and administration in the Fentora label and Risk Minimization Action Plan.

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