On May 17, 2019 the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued this Lemtrada Drug Safety Update, “Lemtrada (alemtuzumab) and serious cardiovascular and immune-mediated adverse reactions: new restrictions to use and strengthened monitoring requirements”, we get this summary:
While an urgent [European Union (EU)] safety review evaluates reports of serious cardiovascular events and immune-mediated reactions, including autoimmune hepatitis, the use of alemtuzumab (Lemtrada) has been restricted and strengthened requirements have been introduced to monitor vital signs and liver function before and during treatment. All patients on alemtuzumab for multiple sclerosis should be alerted to these risks and what to do if symptoms occur.
From that MHRA May 2019 Lemtrada Drug Safety Update, we have compiled this list of serious side effects which have been reported in MS patients using Lemtrada “particularly within 3 days of dosing”:
Cases of cardiovascular reactions
Pulmonary hemorrhage
Myocardial infarction
Arterial dissection
Stroke (hemorrhagic and ischemic)
Cases of immune-mediated disorders
Autoimmune hepatitis
Hemophagocytic lymphohistiocytosis
We will continue to watch for reports of serious cardiovascular events and immune-mediated reactions involving Lemtrada.
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