FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

FDA Warns of Stroke, Artery Lining Tear Risks for Lemtrada

Dec. 10, 2018

The FDA issued a warning for safety risks in patients with multiple sclerosis shortly after receiving Lemtrada (alemtuzumab).

The agency’s alert warns of rare but serious cases of stroke and tears in the lining of arteries in the head and neck of MS patients after receiving the drug.

The agency has updated Lemtrada’s labeling prescribing information and the patient medication guide as well as the boxed warning.

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