Fibristal, for uterine fibroids, pulled from Canadian market

1 October 2020

Health Canada is informing Canadians that Allergan has decided to withdraw the drug Fibristal (ulipristal acetate), used to treat uterine fibroids, from the Canadian market, initiating the recall on September 24.

Allergan, which since May this year is part of US pharma major AbbVie (NYSE: ABBV), made this decision in response to a number of international cases of serious liver injury requiring liver transplantation. The company determined that it is not possible to identify which patients are most at risk of developing liver injury, nor any measures that could further reduce the risk.

Just last month, the European Medicines Agency’s Pharmacovigilance Risk Committee (PRAC) recommended the revocation of the marketing authorization of products containing ulipristal acetate used for the treatment of symptoms of uterine fibroids. These include generics and Gedeon Richter’s (RICHT: HB) Esmya brand.

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