Esmya: liver injuries lead to review by Pharmacovigilance Risk Assessment Committee
The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has launched a review of Esmya (ulipristal acetate) and made an initial assessment of four cases of liver injury and considered that Esmya could be the cause. Three of those cases ended in liver transplantation according to EMA. Analysts noted that some 670,000 patients have received Esmya, and “this appears to be a standard review procedure". Also a high dose of the compound is already approved in the U.S. as an emergency contraceptive.
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