The European Medicines Agency’s (EMA)  Pharmacovigilance  Risk Assessment Committee  (PRAC), at which the HPRA participates, have initiated a review  (Article 20 Referral) of Lemtrada following reports of  Cardiovascular events (stroke, myocardial Infarction and arterial dissection) and Immune-mediated events of autoimmune hepatitis and haemophagocytic lymphohistiocytosis. As temporary measures while the review is ongoing PRAC have recommended restriction of indication – Lemtrada should only be started in adults with relapsing-remitting multiple sclerosis that is highly active despite treatment with at least two disease modifying therapies or where other disease-modifying therapies cannot be used.  Patients being treated with Lemtrada who are benefitting from it may continue treatment in consultation with their doctor.

 

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