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Fentanyl buccal tablet (Fentora) Safety Information Update


September 15, 2007, the US Food and drug Administration, the American's equivalent to the Saudi Food and Drug Authority (SFDA), announced important safety information regarding Fentanyl buccal tablet marketed under the trade name ( Fentora®) .

Fentanyl citrate is a pure opioid analgesic used to achieve analgesia. As other opioid agonists, its pharmacological effects include analgesia, anxiolysis, euphoria, feelings of relaxation, respiratory depression, constipation, miosis, and cough suppression. Fentora is indicated only for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain .

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.

Action that Healthcare Professional should follow:

  • Do NOT use FENTORA in opiod non-tolerant patients
  • Use FENTORA only for labeled indications
  • Do not prescribe FENTORA for patients with acute pain, postoperative pain, headache/migraine, or sports injuries
  • Do not substitute fentora for other fentanyl-containing products

Action that Public should follow:

  • For unrelieved breakthrough pain (BTP), patients should NOT take more than 2 FENTORA tablets per BTP episode.
  • Patients MUST wait at least 4 hours before treating another BTP episode with FENTORA.

Report Adverse Drug Reactions to the Saudi FDA:

The public and health professionals are encouraged to report adverse drug reactions to the National Pharmacovigilance Center on the Internet at :