Fibristal (ulipristal acetate) is approved in Canada to treat signs and symptoms of a type of non-cancerous tumour in the uterus (uterine fibroids) in women of childbearing age.
The Department is again reviewing the risk of serious liver injury associated with Fibristal, in response to a new international case of liver injury that led to a liver transplantation, and the European Medicines Agency’s recommendation to revoke the marketing authorization of the ulipristal acetate medication called Esmya in Europe.
In a 2018 safety review, Health Canada concluded that there may be a link between Fibristal use and risk of serious liver injury. Health Canada is again reviewing the risk of serious liver injury associated with Fibristal, in response to a new international case of liver injury that led to a liver transplantation.
The department is also evaluating the recommendations from the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee to revoke the marketing authorisation of Esmya for uterine fibroids in Europe, and is working with the Canadian manufacturer of Fibristal to determine the appropriate next steps in Canada.
The company was also directed to conduct specific studies to look at the effectiveness of these new measures.
The measures include:
- restricting the drug’s use to women with no previous or current liver problems;
- restricting the use of more than one course of treatment to women who are not eligible for surgery;
- requiring more frequent liver function tests; and
- creating a healthcare professional brochure and a patient alert card about the risks of serious liver injury.
Reference:
https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2020/73939a-eng.php
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