EMA calls for pause in Esmya use, pending safety review

13 February 2018

The safety board of the European Medicines Agency says that doctors should stop initiating treatment with Esmya (ulipristal acetate), pending a safety investigation.

The review of Allergan’s (NYSE: AGN) uterine fibroids therapy, which is currently pending US Food and Drug Afministration approval, was initiated following reports of serious liver injury, including liver failure leading to transplantation.

In light of the reports, the agency’s Pharmacovigilance Risk Assessment Committee (PRAC) is currently looking again at the benefits and risks of using the drug.

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