Drug safety regulators for the European Union recently recommended that Lemtrada use be restricted to certain limited patient populations due to serious side effects linked to Lemtrada.
This November 5, 2019 Multiple Sclerosis News Today report, “EMA Safety Group Advises Lemtrada Be Limited to ‘Highly Active’ RRMS Patients at Hospitals with ICUs”, provides details about this action by the Pharmacovigilance Risk Assessment Committee (PRAC) — a part of the European Medicines Agency (EMA):
Specifically, reports of fatalities and severe effects were associated with immune complications that included autoimmune hepatitis (immune-caused liver damage) and hemophagocytic lymphohistiocytosis (a disorder that may affect several organs in the body), and hemolytic anemia (abnormal red cell breakdown). Some immune reactions could happen “many months” after treatment with Lemtrada, PRAC noted.
Reports also surfaced of severe and deadly heart, circulation, and bleeding disorders, including heart attack, stroke, bleeding in the lungs, and cervicocephalic arterial dissection (tears in the arteries from the head and neck). These adverse events, PRAC said, could develop within days of Lemtrada’s use.
We will watch for more Lemtrada drug safety developments in the medical and regulatory realms while we continue to investigate possible drug injury cases for patients seeking legal compensation for serious side effects.
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