Fentanyl Buccal Tablets (Fentora)

FentoraCephalon has issued two “Dear Health Care Professional” letters to inform prescribers and other health care providers of important safety information regarding fentanyl buccal tablets (Fentora). Fentanyl buccal tablets are indicated only for breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for underlying persistent cancer pain.

Serious adverse events, including deaths, have occurred in patients treated with Fentora. The deaths occurred as a result of improper patient selection (e.g., use in patients not tolerant to opioid therapy), improper dosing, and/or improper product substitution. Appropriate patient selection and proper dosing and administration of Fentora are essential to reduce the risk of respiratory depression. Key safety information is as follows:
•Fentora should not be used in patients who are not tolerant to opioid therapy.

•It should be used only for labeled indications.

•It should not be prescribed for patients with acute pain, postoperative pain, headache, migraine, or sports injuries.

•Fentora is not a generic version of Actiq or other fentanyl-containing products and should not be substituted.

•For unrelieved breakthrough pain, patients should not take more than two tablets per episode of breakthrough pain.

•Patients must wait at least four hours before treating another episode of breakthrough pain with Fentora.

(Sources: FDA)