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The prescription medication Fentora has been implicated in four deaths this summer. The drug is intended for use in cancer patients suffering from intense pain and who are already tolerant of opioid drugs. Some doctors, however, are prescribing the drug for off-label uses, such as headaches and back pain. Fentora maker, Cephalon, responded to the deaths by issuing letters to doctors warning of the risks associated with off-label prescription of Fentora.

The company has been accused of marketing Fentora to doctors for off-label uses. The active ingredient in the drug is fentanyl, an extremely addictive and powerful substance more than 80 times more powerful than morphine. The Schedule II drug has a high risk of fatal overdose and abuse, and is placed in the same category as cocaine and methamphetamines for this reason.

Fentora is an oral lozenge designed to act as the successor to Actiq, Cephalon’s pain lollipop, which has now been marketed in the generic market after its 1999 introduction. Fentora was approved only about 12 months ago and has been a very good performer for Cephalon, generating $68 million in sales over the first six months of this year, but the so called “Dear Doctor” letters may spell trouble for the future.

For more information on this subject matter, please refer to the section on Drugs, Medical Devices, and Implants.

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