MedWatch report issued for Fentora

September 17, 2007

FDA and Cephalon issue warning letters on Fentora use

Letters have been issued to both physicians and other healthcare professionals regarding the appropriate use of fentanyl buccal tablets (Fentora, Cephalon) following recent reports of deaths associated with the drug's use. The letters state that the painkiller should only be used for breakthrough pain in opioid-tolerant patients who are already receiving opioid therapy for treatment of persistent cancer pain. "Opioid-tolerant" is described as patients who are taking 60 mg or more of oral morphine per day, 30 mg/day or more of oxycodone, 8 mg/day or greater of oral hydromorphone, 25 mcg transdermal fentanyl per hour, or an equianalgesic dose of another opioid for longer than a week's duration. Patients not requiring "round-the-clock" opioid therapy are considered opioid non-tolerant and should not use Fentora. Cephalon emphasized that Fentora should not be used as a substitute for any other fentanyl-containing product.

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