FDA Issues Public Health Warning About Cancer Pain Drug Fentora

The FDA would like to let you know that a medicine meant to be used to control pain in patients who have become tolerant to morphine and other similar drugs is being used incorrectly and some patients have died as a result.

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.

If your doctor has given you this medicine for a migraine or other pain and you are not tolerant to narcotic painkillers, or you believe that this medicine has been substituted for another medicine improperly, you’ll want to heed this warning. Call your doctor and ask some tough questions.

DA Warns of Potential Serious Side Effects with Breakthrough Cancer Pain Drug [FDA]