FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Canadian Regulator Announces Restrictions on Allergan’s Uterine Fibroid Drug

Jan. 24, 2019
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Health Canada announced that it will restrict the use of Esmya (ulipristal acetate), Allergan’s uterine fibroid drug, citing major liver injury risk.

The agency said women with a history of liver problems should not use the drug, sold in Canada as Fibristal. Only those of childbearing age who cannot undergo surgery to remove the fibroids should seek more than one treatment course for the drug.

Regulators in Europe, where it is sold by Hungarian manufacturer Richter, have also suggested restrictions on the drug for certain patients to minimize risk.

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