FDA warns against use of Fentora by non-cancer patients

WASHINGTON The Food and Drug Administration on Friday said that allowing Cephalon to sell its cancer pain drug Fentora to patients without cancer could lead to potentially fatal abuse, according to published reports.

The company is looking for approval to market the drug for sudden pain bouts in non-cancer patients. The FDA staff concluded that the risks of an “unintentional potentially fatal overdose,” as well as of misuse and abuse, are “extremely high” and raise “serious safety concerns,” an FDA document said.

The drug has been prescribed “off label” to treat ailments such as migraine headaches, sports injuries and back pain. The agency has said that it is dangerous to use Fentora to treat short-term pain such as migraines, and only patients who take opioids regularly and have developed a tolerance to narcotic pain medicines should use Fentora.

An FDA advisory panel will meet Tuesday to discuss the expanded use. Cephalon expects the FDA to make a final decision by Sept. 13.