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# Stroke Risk Safety Alert on Genzyme’s Lemtrada/Campath
- URL: https://www.fdaweb.com/stroke-risk-safety-alert-on-genzymes-lemtrada-campath/
- Published: 2018-11-29T12:00:00.000Z
- Updated: 2026-09-15T00:47:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142923

FDA has issued a [drug safety alert](https://www.fda.gov/downloads/Drugs/DrugSafety/UCM626584.pdf?ref=fdaweb.com) to warn about rare but serious cases of stroke and tears in the lining of arteries in the head and neck that have occurred in patients with multiple sclerosis shortly after they received Genzyme’s Lemtrada (alemtuzumab). “As a result, we have added a new warning about these risks to the prescribing information in the drug label and to the patient Medication Guide,” the alert says. The stroke risk has also been added to the existing Boxed Warning, FDA’s most prominent warning. Lemtrada was approved by the agency in 2014\. Genzyme also markets alemtuzumab under the brand name Campath, which was approved in 2001 to treat B-cell chronic lymphocytic leukemia. It is also being updated to include the new safety risks.