FDA Warns of Stroke and Arterial Dissection Risk With MS Drug

The agency is alerting patients and physicians to the risk and has added information to the boxed warning for alemtuzumab.

FDA Warns of Stroke and Arterial Dissection Risk With MS Drug

In a safety announcement issued today, the US Food and Drug Administration is warning about rare but serious risks of stroke and tears in artery linings of the head and neck that have occurred in patients with multiple sclerosis (MS) shortly after receiving alemtuzumab (Lemtrada; Genzyme). The warning has been added to the prescribing information in the label, as well as to the patient medication guide. To further call attention to the risk, the agency also has added it to an existing boxed warning.

“Healthcare professionals should advise patients at every Lemtrada infusion to seek immediate emergency medical attention if they experience symptoms of ischemic or hemorrhagic stroke or cervicocephalic arterial dissection,” the agency says in its announcement. “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.”

Lemtrada was approved in 2014 for the treatment of relapsing MS. The FDA says since then the agency has received reports of 13 cases of ischemic and hemorrhagic stroke or arterial dissection from around the world. The safety announcement states that 12 of the 13 cases occurred within 1 day of patients’ receiving an IV infusion.

Currently, the drug is only available to MS patients through a restricted distribution program. However, alemtuzumab is also approved under the brand name Campath (Berlex Laboratories) for treatment of patients with B-cell chronic lymphocytic leukemia. According to the FDA, Campath’s labeling also will be updated to include the new warning.


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