The FDA is warning consumers about the risk of rare but serious cases of stroke and tears in the lining of arteries in the head and neck associated with Sanofi’s multiple sclerosis drug, Lemtrada.
Lemtrada received FDA approval for the treatment of relapsing forms of multiple sclerosis in November 2014 and was launched in the U.S. in December 2014 with a boxed warning regarding the risk of autoimmunity, infusion reactions, and malignancies.
The new risks have been reported by 13 patients worldwide since Lemtrada’s approval. The FDA is adding information about the risks to the drug's prescribing label, medication guide and existing black box warning.
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