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FDA Warns of Painkiller Fentora Misuse

Patients Must Take Fentora Exactly as Instructed, FDA Says

By Miranda Hitti
WebMD Health News

Reviewed By Louise Chang, MD

Sept. 26, 2007 -- The FDA today alerted doctors and patients about improper and potentially deadly misuse of Fentora tablets.

Fentora is a strong narcotic painkiller that should only be used for treating breakthrough pain in cancer patients who are opioid-tolerant, meaning they take narcotic pain medicines around the clock.

The FDA has received reports of death and life-threatening side effects in patients who have taken Fentora. The reported deaths were the result of improper selection of patients, dosing, or improper product substitution, according to the FDA.

Stacey Beckhardt, a spokeswoman for Cephalon, the drug company that makes Fentora, tells WebMDvia email that "to date, three deaths may have been related to use in patients who were not prescribed opioids around the clock and/or improper dosing of the medication. A fourth death was reported to be a suicide."

The number of patients who experienced adverse events isn't available, Beckhardt tells WebMD.

The FDA stresses the following safety information for Fentora:

  • Fentora shouldn't be used to treat any type of short-term pain including headaches, migraines, postoperative pain, or pain due to injury.
  • Fentora shouldn't be used by patients who only take narcotic pain medications occasionally.
  • Health care professionals must not directly substitute Fentora for other fentanyl medicines, including Actiq.
  • Doctors must select the Fentora dose carefully for each patient.
  • Patients taking Fentora and their caregivers must understand how to use Fentora safely and follow the directions in the drug's Medication Guide exactly.
  • Health care 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.

Cephalon adds that patients should wait at least four hours before taking Fentora for another episode of breakthrough cancer pain.

The FDA has asked Cephalonto strengthen warnings and improve the dosing instructions on the drug's label. Cephalon says it's working with the FDAon that andsent a letter to doctors earlier this month advising them of the adverse events and deaths reported for Fentora.

SOURCES: News release, FDA. FDA: "Public Health Advisory: Important Information for the Safe Use of Fentora (fentanyl buccal tablets)." Stacey Beckhardt, spokeswoman, Cephalon Inc.

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