ROCKVILLE, Md., Sept. 13 -- Adverse events including deaths have been linked to Fentora, a drug for breakthrough pain in cancer patients who are opioid tolerant, according to the FDA.
Cephalon, maker of the fentanyl(Drug information on fentanyl) buccal tablets marketed as Fentora, has issued letters warning physicians of the risks and outlining a strict set of recommendations for the drug's use.
According to the FDA the deaths occurred as "a result of improper patient selection (e.g. use in opioid non-tolerant patients), improper dosing, and/or improper product selection."
The drug is indicated only for the management of breakthrough pain in patients with cancer in persistent pain who are already receiving and who are tolerant to opioid therapy.
