FDA Issues Fentora Warning
The Food and Drug Administration issued a warning today about the risk of potentially fatal overdoses with Fentora, a narcotic painkiller manufactured by Cephalon. The action comes less than two weeks after the company sent a letter to doctors notifying them of three drug-related deaths.
Off-Label Use Dangerous
Last October, the FDA approved Fentora for use in cancer patients who experience intense bursts of pain. However, the drug is also sometimes prescribed to treat migraines and short-term pain in non-cancer patients.
According to the government warning, using Fentora for off-label, or non-approved, purposes could lead to deadly overdose, particularly in patients who are not taking narcotic painkillers on a regular basis.
All three reported deaths were in patients taking Fentora for off-label uses. Two of the patients were taking the drug to treat migraine headaches.
Cephalon under Investigation
Cephalon has been accused of marketing its drugs for uses not approved by the FDA and is currently the target of state and federal investigations. The company has denied the allegations.
Federal regulators have asked the company to strengthen the drug’s warnings and educate doctors and patients on proper use of Fentora.