FDA Warns of Painkiller Fentora Misuse
Patients Must Take Fentora Exactly as Instructed, FDA Says
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 WebMD via 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
- 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
- Health care professionals who prescribe Fentora and patients who use
Fentora (and their caregivers) should be aware of the signs of fentanyl
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 Cephalon to
strengthen warnings and improve the dosing instructions on the drug's label.
Cephalon says it's working with the FDA on that and sent a letter to
doctors earlier this month advising them of the adverse events and deaths
reported for Fentora.