FDA Warns of Rare but Serious Risks Linked to MS Drug Alemtuzumab

Regulatory Affairs Professionals Society
01 Dec, 2018 ,

The US Food and Drug Administration FDA warned that serious cases of stroke and tears in the lining of arteries in the head and neck have occurred in patients with multiple sclerosis MS shortly after they received Sanofis Lemtrada alemtuzumab The thirteen cases reported in the FDA Adverse Event Reporting System included one patient who suffered hemorrhagic stroke and died