In November 2018 the FDA mandated Lemtrada label changes, which include an increased risk of strokes warning being added to the “Black-Box Warning” and a new part — 5.3 Stroke and Cervicocephalic Arterial Dissection — being added to the WARNINGS AND PRECAUTIONS section of the current Full Prescribing Information, or drug label, for Lemtrada.
Related to this Lemtrada label change, on November 29, 2018 this FDA Drug Safety Communication was issued, “FDA warns about rare but serious risks of stroke and blood vessel wall tears with multiple sclerosis drug Lemtrada (alemtuzumab)”. That document included some basic facts about these serious side effects in the Data Summary section:
In nearly 5 years since FDA approved Lemtrada (alemtuzumab) in 2014 to treat relapsing [multiple sclerosis (MS)], we identified 13 worldwide cases of ischemic and hemorrhagic stroke and cervicocephalic arterial dissection. These 13 cases reported in the FDA Adverse Event Reporting System (FAERS) database occurred within 3 days of administration of the drug to patients with MS. Ten of the cases occurred in the U.S. and three occurred in Europe.
We will continue to monitor the safety profile of Lemtrada, watching for significant developments reported in the medical literature or by means of future FDA drug safety warnings.[View full article at original source]