FDA Warns of Stroke, Dissection Risk With MS Drug Alemtuzumab

Megan Brooks

November 29, 2018

The US Food and Drug Administration (FDA) is warning about the potential for "rare but serious" cases of ischemic and hemorrhagic stroke and cervicocephalic arterial dissection associated with alemtuzumab (Lemtrada, Genzyme).

In the nearly 5 years since the agency approved alemtuzumab for relapsing forms of multiple sclerosis (MS), cases involving 13 patients have been reported to the FDA Adverse Event Reporting System database, the agency said today in a safety communication.

These 13 patients included seven with hemorrhagic stroke, one with hemorrhagic stroke and dissection of both vertebral arteries, two with ischemic stroke, one with ischemic stroke and dissection of bilateral carotid and right vertebral arteries, two with dissection that involved the right carotid and left vertebral arteries, and two with stroke of unspecified type. One patient who suffered hemorrhagic stroke died.

Ten of the cases occurred in the United States, and three occurred in Europe. For 12 of the 13 patients, these adverse events occurred within 1 day after initiating treatment with alemtuzumab.

The FDA said most for most of the cases, there was insufficient detail to fully assess individual risk factors, but their occurrence soon after starting alemtuzumab suggests an association.

Although the etiology remains unclear, these adverse events occurred within the same time frame as that for cytokine release syndrome, a systemic inflammatory response syndrome known to occur after alemtuzumab administration. Cytokine release syndrome may contribute to these outcomes, the agency said.

Symptoms of cytokine release syndrome were reported in some patients, including one who experienced cytokine storm and who died of hemorrhagic stroke. However, in many cases, information was insufficient to determine whether cytokine release syndrome occurred with stroke or arterial dissection, the FDA said.

The FDA has added a new warning about these risks to the prescribing information in the drug label and to the patient medication guide. In addition, the risk for stroke has been added to the existing boxed warning on the drug.

Cases of ischemic stroke and intracerebral hemorrhage have also been reported in patients treated with alemtuzumab under the brand name Campath for B-cell chronic lymphocytic leukemia (B-CLL) and other leukemias or lymphomas, the FDA said.

In these cases, either potential contributing factors were present, including underlying risk factors and concomitant medications, or the reports were missing this information. For these reasons, a causal association between alemtuzumab and stroke in patients being treated for hematologic cancers could not be established, the FDA said. Nonetheless, the drug label will be updated to also include these risks.

The FDA said healthcare providers should advise patients before every alemtuzumab infusion to seek immediate emergency medical attention if they experience symptoms of ischemic or hemorrhagic stroke or cervicocephalic arterial dissection.

"The diagnosis is often complicated because early symptoms such as headache and neck pain are not specific. Promptly evaluate patients who complain of symptoms consistent with these conditions," the FDA said.

Healthcare professionals are encouraged to report any adverse reactions related to alemtuzumab to MedWatch, the FDA's adverse event reporting program.

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