FDA: ‘Rare but serious’ risk of stroke with MS drug alemtuzumab

The FDA is amending its label for alemtuzumab, a drug used to treat multiple sclerosis (MS) and leukemia, after 13 patients reported cases of ischemic stroke, hemorrhagic stroke or arterial dissection related to use of the medication.

The FDA first approved alemtuzumab for the treatment of B-cell chronic lymphocytic leukemia in 2001, under the brand name Campath, according to a statement. In 2014, the agency again approved the drug to treat relapsing forms of MS under the brand Lemtrada, but negative reports began to surface.

Twelve of the 13 reported cases of stroke and dissection occurred within a day of a patient receiving Lemtrada, the FDA reported. Patient-reported symptoms of numbness, weakness, confusion and reduced coordination and functionality led to diagnoses of stroke and tears in the arterial linings of patients’ heads and necks.

The FDA warned these symptoms are “rare but serious”—there have only been 13 related cases of stroke or arterial dissection to date—but they can lead to permanent disability or death.

“We have added a new warning about these risks to the prescribing information in the drug label and to the patient medication guide,” officials wrote. “We have also added the risk of stroke to the existing ‘Boxed Warning,’ FDA’s most prominent warning.”

The agency said it would be extending those changes to Campath labels, though all reported cases of stroke and arterial dissection occurred in Lemtrada patients.