Health Canada to conduct review of a new potential safety risk of Fibristal

16 March 2018

Medicines regulator Health Canada is advising Canadians that it will be conducting a safety review of Fibristal (ulipristal acetate), a drug used to treat uterine fibroids in women that is marketed by Ireland incorporated Allergan plc (NYSE: AGN).

Health Canada's review is a result of Canadian and European reports of serious adverse events affecting the liver.

Last month, the European Medicines Agency said that doctors should stop initiating treatment with ulipristal acetate, which Allergan markets under the brand name Esmya in Europe, pending a safety investigation, initiated following reports of serious liver injury, including liver failure leading to transplantation.

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