FDA: MS Drug Linked to Cases of Stroke, Blood Vessel Wall Tears

Most cases occurred within 1 day of receiving Lemtrada
Most cases occurred within 1 day of receiving Lemtrada

The Food and Drug Administration (FDA) has issued a warning regarding rare cases of ischemic and hemorrhagic stroke and cervicocephalic arterial dissection in patients with multiple sclerosis (MS) shortly after receiving Lemtrada (alemtuzumab; Sanofi Genzyme). Alemtuzumab, a monoclonal antibody, is also approved for the treatment of B-cell chronic lymphocytic leukemia (B-CLL) under the brand name Campath (alemtuzumab; Sanofi Genzyme).

Sine the approval of Lemtrada in 2014, the Agency has identified 13 cases worldwide of ischemic and hemorrhagic stroke or arterial dissection that occurred shortly after the patient received Lemtrada; 1 patient who suffered a hemorrhagic stroke died. Most cases (12/13) occurred within 1 day of receiving Lemtrada; 1 patient reported symptoms 3 days after starting treatment. While the etiology is unknown, the adverse events appear to have occurred within the same time frame as cytokine release syndrome, an inflammatory response associated with Lemtrada use. Reports of ischemic stroke and intracerebral hemorrhage have also been documented in patients treated with Campath for B-cell CLL and other leukemias/lymphomas.

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The prescribing information and Medication Guide for Lemtrada have been updated with a new warning to reflect these risks. In addition, the risk of stroke has been added to the existing Boxed Warning. The Campath drug labeling has also been updated to include these risks in the Adverse Reactions section under Postmarketing Experience.

Healthcare professionals should advise patients at each infusion to seek medical attention if they experience symptoms of ischemic or hemorrhagic stroke or cervicocephalic arterial dissection. Patients who complain of symptoms suggestive of these conditions should be promptly evaluated.

Lemtrada is available only through the Lemtrada Risk Evaluation and Mitigation Strategy (REMS) Program

For more information visit FDA.gov.