A preliminary Food and Drug Administration report released Friday recommended against the approval for Fentora, a potent narcotic pain medicine that is now approved only to treat pain flare-ups in cancer patients.

The drug has been prescribed "off label" to treat ailments such as migraine headaches, sports injuries and back pain.

Although doctors are free to prescribe medicines for any condition they think appropriate, drug manufacturers can promote products in the United States only for uses approved by the FDA.

But the FDA has said that it is dangerous to use Fentora to treat short-term pain such as migraines, and that Fentora should be used only by patients who take opioids regularly and have developed a tolerance to narcotic pain medicines.

Last September, the FDA issued a public warning letter for Fentora after reports that it had been linked to several deaths as well as respiratory problems and other serious side effects.

The FDA advisory committee is meeting in Gaithersburg, Md., and company officials have said that they expect the FDA to make a final decision by Sept. 13.

Cephalon has scheduled a 5:30 p.m. conference call today to discuss the panel's meeting.

Company shares were priced at $61.04 this morning in Nasdaq trading, up 88 cents from the previous close.