Off-label Prescription of Fentora Linked to Deaths

Scott Kappes

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Last week Cephalon, the makers of the powerful painkiller Fentora issued warning letters to doctors about the risks of prescribing Fentora for off-label uses. The letters comes after four deaths were linked to off-label use of the drug. The labeled use for Fentora is to treat breakthrough pain patients with cancer who are already receiving and are tolerant of opioid therapy. This is where the problem comes in.

Doctors have been prescribing Fentora to patients for back pains and headaches to patients that are not tolerant of opioid therapy and the drug is just powerful for them. Fentanyl, the active ingredient in Fentora is over 80 times more powerful than morphine, so one could see how it could be overpowering for someone who was not tolerant of opioids. The label does clearly state that the drug is not intended to be used in this fashion, but Cephalon is being investigated in three different probes after accusations surfaced that the company was marketing Fentora for off-label uses.

Doctors are allowed to prescribe drugs as they see fit, but it is illegal for a pharmaceutical company to market a drug for off-label uses. If this found to be true the company could be in a heap of trouble as their reckless greed and disregard for patient safety would cast the blame for these deaths squarely on the shoulders of Cephalon.

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