The Food and Drug Administration is alerting health care professionals and consumers to concerns over the use of Fentora (fentanyl buccal) tablets after recent reports of deaths and other adverse events.
Fentora, a potent opioid pain medication, is used only for treatment of breakthrough pain in cancer patients receiving opioid treatment and who have become tolerant to it. Breakthrough pain is intense increases in pain that occur with rapid onset, even when opioid pain-control medication is being used. Patients who take narcotic pain medications daily and around-the-clock develop tolerance and are more resistant to the dangerous side effects of these medications than patients who take narcotic pain medication on a less frequent basis.
The deaths reported were the result of improper selection of patients, dosing, or improper product substitution.
"FDA is monitoring this issue very closely," said Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research. "We are working with the manufacturer to ensure the safest use of this medicine. Health care professionals and patients need to be aware of the potential for fatal overdose with the improper use of Fentora."
In its Public Health Advisory and Health Care Professional Sheet published today, FDA warned physicians and other health care professionals that it is critical to follow product labeling when administering Fentora. FDA further stated that it is dangerous to use Fentora for any short-term pain such as headaches or migraines. It is critical that Fentora not be used in patients who are not opioid tolerant.
Patients also must be under a doctor's care and close supervision while taking Fentora and the dose should be carefully adjusted to control breakthrough pain adequately.