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Four deaths this summer have been linked to the cancer pain medication Fentora. Cephalon Inc., the drug’s maker, has sent letters to doctors warning of these deaths. Fentora is an extremely powerful and addictive opiate approved by the FDA to treat pain in cancer patients. Doctors, however, are prescribing the drug for “off-label” uses, like headaches and back pain. The company is accused of promoting the drug for “off-label” prescription and is being investigated in three separate probes.

Fentora is the successor to Actiq, which hit the market in 1999. Both drugs contain fentanyl, a substance 80 times more powerful than morphine. The DEA classifies fentanyl as a Schedule II substance, placing it in the same category as cocaine and methamphetamine. The drugs classified as Schedule II are also considered to have the highest potential for abuse and an associated risk of fatal overdose.

Of the four reported deaths tied to the drug, all came from the dug being used differently than its label indicates. Two of the patients were prescribed the drug for headaches and another used the drug to commit suicide but was not prescribed at all.

Doctors are allowed to prescribe drugs at their own discretion for “off-label” uses; however, it is illegal for a company to market a drug for “off-label” use. The FDA says that they are committed to safe use of this medication and are doing all they can to assure it.

Cephalon declined to comment on the various investigations but said they were ongoing and it continued to cooperate with each one. Cephalon’s Ms. Beckhardt said the company “promotes its medications consistent with the labeled indication” and added that it was “taking active steps to re-emphasize the importance of adhering to the labeling information” for Fentora.

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

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