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Safe Use of Fentora (fentanyl buccal tablets) - Full Version

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On September 26, 2007, the Food and Drug Administration issued a Public health advisory titled: Important Information for the Safe Use of Fentora.

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

FDA issued this public health advisory to alert patients, caregivers, and healthcare professionals to important information on 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.

Fentora contains fentanyl, a very potent narcotic (opioid) pain medicine. It is only approved for breakthrough cancer pain in patients who are opioid-tolerant, meaning those patients who take a regular, daily, around-the-clock narcotic pain medicine. Patients who take narcotic pain medications every day, around-the-clock develop tolerance, meaning they are more resistant to the dangerous side effects of narcotic pain medicines than patients who only occasionally take these medicines. For patients who are not opioid-tolerant, the amount of fentanyl in Fentora is large enough to cause dangerous side effects, such as respiratory depression (severe trouble breathing) and death. Patients should ask their doctor if they are opioid-tolerant before taking 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.
    • Fentora should not be used to treat any type of short-term pain including headaches or migraines, postoperative pain, or pain due to injury.
    • Fentora should not be used by patients who only take narcotic pain medications occasionally.
  • 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.
    • Doctors must select the Fentora dose carefully for each patient.
  • Patients who take Fentora and their caregivers must understand how to use it safely and follow the directions exactly. Directions for taking Fentora are provided in the medication guide for patients.
  • 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.

The Fentora product label and medication guide for patients are being updated to add new safety information. In addition, Cephalon, the manufacturer of Fentora, issued "dear healthcare professional" and "dear doctor" letters, which are available at W-W-W dot F-D-A dot GOV slash MedWatch slash safety slash 2007 slash safety07 dot h-t-m number sign Fentora. FDA will provide updates as new information is available.

We urge healthcare professionals and patients to report side effects that occur while using Fentora to us at 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 MedWatch.

Updated information about drugs with emerging safety concerns is available 24 hours a day at our Web site W-W-W dot F-D-A dot GOV slash C-D-E-R.


Date created: September 27, 2007


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