FDA warns on risks of improper Fentora use

The US Food and Drug Administration has issued a warning regarding the use of Cephalon's cancer pain medication Fentora (fentanyl buccal tablets) after reports of deaths and other adverse events in patients treated with the drug. The FDA said that the events in question were the result of improper selection of patients, inappropriate dosing and product substitution.

The agency explained that Fentora, which is a potent opioid-based pain medication, should only be used for the treatment of breakthrough cancer pain in patients who are opioid tolerant, and are therefore more resistant to the drug's potential side effects. Earlier this month, Cephalon sent letters to physicians and health care providers advising them of the reported deaths and has been asked by the FDA to strengthen the product's warning label and dosing instructions.