FDA says wider use of Cephalon drug carries risks of misuse.

FDA May 8 said encouraging wider use of Cephalon's pain-killing drug Fentora raises the risk of potentially fatal misuse of the drug.

Fentora already is approved to treat severe pain flare-ups in cancer patients. According to an article in "The Washington Post," FDA will ask a panel of outside experts whether it should be approved to treat pain in non-cancer patients, a larger market that includes those suffering from back and nerve pain.

But FDA took a cautious tone in draft questions posted to its Web site, stating that "Fentora has attributes that make it particularly attractive to abusers" and questioning whether broader approval would "lead to widespread abuse."

The drug is currently used by about 20,000 patients, according to Cephalon. Fentora along with Actiq, an older version of the drug, accounted for 29% of Cephalon sales last year.

FDA first approved the drug in 2006 with a strict indication for adults suffering from cancer pain who are already taking opioid drugs, a class of narcotics that includes morphine and codeine as well as Fentora.

But FDA said the drug has frequently been used outside those recommendations, resulting in negative side effects and death. Cephalon has reported five patient deaths due to improper use.

Cephalon said in a statement there is "no evidence that Fentora poses risks of abuse and diversion greater than other opioids."

The company cited a study that showed medications like Fentora are no more appealing to heroin addicts than other types of narcotics.

Cephalon spokeswoman Stacey Beckhardt acknowledged that many doctors already prescribe the drug off-label, or for uses not approved by FDA. She said the company felt a responsibility to expand the drug's FDA-approved indication to ensure it is used safely.