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U.S. Department of Health and Human Services

For Consumers

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Serious Side Effects with Cancer Pain Drug

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After receiving reports of deaths and other serious side effects, FDA is alerting consumers and health care professionals to concerns about the use of Fentora (fentanyl buccal) tablets, a potent opioid pain medication. 

Fentora is used only for treating breakthrough pain in cancer patients receiving opioid treatment and who have become tolerant to it—those who take a regular, daily, around-the-clock narcotic pain medicine. Breakthrough pain is intense increases in pain that occur rapidly, even when opioid pain-control medication is being used.

People who develop tolerance to narcotic pain medicines are more resistant to the dangerous side effects of these medications than those who take narcotic pain medication less frequently.

The deaths reported indicate that some cancer patients

  • should not have been prescribed this medicine
  • were prescribed the wrong Fentora dose
  • took too many Fentora doses
  • received Fentora as a substitute for another fentanyl-containing product that is not equal to Fentora
Important Safety Information
  • Ask your doctor if you are opioid-tolerant before taking Fentora. The drug 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, pain after an operation, or pain due to injury.
  • People who only take narcotic pain medications occasionally should not use Fentora.
  • Do not substitute Fentora for other fentanyl medicines, including Actiq. The dosage strength of fentanyl in Fentora is NOT equal to the same dosage strength of fentanyl in other fentanyl-containing products. Using the same dose can result in a fatal overdose.
  • Read the Medication Guide that comes with Fentora,and follow the directions exactly.  
Watch For These Signs

Get medical attention right away if you have any of these signs:

  • trouble breathing or shallow breathing
  • tiredness, extreme sleepiness, or sedation
  • inability to think, talk, or walk normally
  • feeling faint, dizzy, or confused
FDA Actions
  • requested the manufacturer, Cephalon Inc., strengthen warnings and improve the dosing instructions in the drug’s product labeling and Medication Guide for patients
  • requested the company improve their education plan for prescribers and pharmacists
  • published a Public Health Advisory and Health Care Professional Sheet warning health care professionals that it is critical to follow Fentora's product labeling
  • monitoring the Fentora issue closely and reviewing available information, including adverse events
  • working with the manufacturer to ensure the safest use of the medicine
  • providing updates as new information is available

Adverse events related to Fentora should be reported to MedWatch, the FDA’s voluntary reporting program:
MedWatch
800-332-1088
Fax: 800-332-0178
Mail: MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20852-9787

This article appears on FDA's Consumer Update page, which features the latest on all FDA-regulated products.

Date Posted: September 28, 2007