Cephalon issued two Dear Healthcare Professional Letters to inform prescribers and other healthcare providers of important safety information regarding Fentora (fentanyl buccal tablet). Fentora is indicated only for the management of breakthrough pain in patients with cancer who are already receiving opioid therapy for their underlying persistent cancer pain, and who are tolerant to it.
Serious adverse events, including deaths, have occurred in patients treated with Fentora. These deaths occurred as a result of improper patient selection (e.g., use in opioid non-tolerant patients), improper dosing, and/or improper product substitution. The healthcare professional letters provide key points regarding appropriate patient selection and proper dosing and administration of Fentora to reduce the risk of respiratory depression.