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agency is cautioning patients and docs about about potentially fatal risks connected with Fentora, a powerful painkiller, because off-label use could result in fatal overdoses. The FDA approved the highly addictive narcotic last year to treat acute pain suffered by cancer patients.
Since then, Fentora has been linked to four deaths and Cephalon is blaming inappropriate prescribing for such ailments as back pain. The drugmaker, however, denies off-label marketing activities. But its being investigated by the US attorney in Philadelphia and the Connecticut attorney general (see page 11 of the latest SEC filing), and faces a congressional probe into off-label treatments.
FDA stressed that Fentora shouldn't be used to treat short-term pain such as migraines and shouldn't be used by patients who aren't taking opioids on a frequent basis. The agency also warned docs against substituting Fentora for other meds, including Actiq, an earlier version of the drug also made by Cephalon. Earlier this month, Cephalom claimed to be working with the FDA to develop a stronger label warning about the risks of misusing the drug, and the FDA asked the drugmaker to do more to educate patients and docs on proper use.