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Safe Use of Fentora (fentanyl buccal tablets) - Overview

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Run Time -- 00:02:47

Welcome to the Food and Drug Administration's drug safety update.

I am Pat Clarke from F-D-A's Center for Drug Evaluation and Research.

On September 26, 2007, we issued a public health advisory regarding important information for the safe use of Fentora, a narcotic medicine for treating pain in cancer patients who are opioid-tolerant.

FDA has received reports of death and life-threatening side effects in patients who have taken Fentora. The reports indicate that:

  • There have been patients who should not have been prescribed this medicine (deaths occurred in patients who did not have cancer and/or were not opioid tolerant);
  • Patients were prescribed the wrong Fentora dose;
  • Patients took too many Fentora doses; and
  • Healthcare professionals substituted Fentora for another fentanyl-containing product that is not equal to Fentora.

FDA is highlighting the following important safety information on Fentora:

  • Fentora should only be used for breakthrough pain in opioid-tolerant patients with cancer.
  • The dosage strength of fentanyl in Fentora is not equal to the same dosage strength of fentanyl in other fentanyl-containing products.
  • Healthcare professionals must not directly substitute Fentora for other fentanyl medicines, including Actiq.
  • Patients who take Fentora and their caregivers must understand how to use it safely and follow the directions exactly.
  • Healthcare professionals who prescribe Fentora and patients who use Fentora and their caregivers should be aware of the signs of fentanyl overdose.

Signs of fentanyl overdose include trouble breathing or shallow breathing; tiredness, extreme sleepiness or sedation; inability to think, talk or walk normally; and feeling faint, dizzy or confused. If these signs occur, patients or their caregivers should get medical attention right away.

To hear the full public health advisory, listen to part two of this broadcast.

We urge healthcare providers and patients to report side effects that occur while using Fentora to the FDA's MedWatch adverse event reporting program by phone at 1-800-F-D-A-ten-88 or by the Internet at F-D-A dot GOV slash M-E-D-W-A-T-C-H.

Date created: September 27, 2007


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