Black Box Warning May Be Unnecessary for Certain Migraine Drugs

Findings from a recent study suggest that the black box warning for triptans and Dihydroergotamine (DHE) may not be necessary for patients with 2 subtypes of migraine headaches.

Researchers saw no side effects in those patient groups, which can include stroke or other cardiovascular side effects. These findings may also have implications for migraine sufferers who also experience auras or disturbed vision, touch, speech, thinking, or strength issues that typically precede a migraine, according to the study, published in Headache.

"There are not enough medicines out there to appropriately manage migraine headaches," said senior author Brad Klein, MD. "At a time in history when an unprecedented number of people are getting hooked on narcotic opiates by way of prescribed medications - as is the case with migraine sufferers as well - we owe it to ourselves as physicians to try medications that could work without the risk of addiction.”

In migraines, the pain is thought to be caused by swelling of the blood vessels to the brain, but basilar and hemiplegic subtypes are believed to constrict blood vessels.

Both triptans and DHE constrict blood vessels and are thought to relieve pain, so patients with these 2 subtypes were excluded from studies.

"As a result no one ever actually showed that these drugs were dangerous, they were just assumed to be dangerous based on their mechanism of action and recent research suggests that the auras are not due to blood vessel constriction,” Dr Klein said.

Researchers conducted a retrospective analysis and collected information on patients whose symptoms indicated basilar or hemiplegic migraine diagnosis and were also treated with DHE or triptan. Only 80 patients met these criteria.

In these 80 patients, researchers found no cases of stroke or heart attack during the routine follow-up period, showing that this medication can be safe for these patient subtypes.

Though other investigators have studied this before, researchers concluded that the current study was the largest group of patients evaluated and also the first to analyze DHE treatment.