FDA Warns Of Potential Serious Side Effects With Breakthrough Cancer Pain Drug

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Breakthrough Cancer Pain Drug

FDA 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