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Health Canada reviews safety of drug Fibristal again following new case of liver injury – Recalls and safety alerts


Health Canada reviews safety of drug Fibristal again following new case of liver injury


OTTAWA – Health Canada continues to monitor safety information involving Fibristal (ulipristal acetate) as it does for all health products on the Canadian market. 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.

Fibristal 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.

In a 2018 safety review, Health Canada concluded that there may be a link between Fibristal use and risk of serious liver injury. The Department informed Canadians of this risk and directed the manufacturer to implement new safety measures. These measures are to minimize the risks and support the safe use of this medication. The company was also directed to conduct specific studies to look at the effectiveness of these new measures. The measures include:

As part of its most recent review of the issue, Health Canada consulted with experts, including international health regulators, healthcare practitioners, and the Society of Obstetricians and Gynaecologists of Canada. This review focused on the treatment of uterine fibroids to better understand the use of Fibristal in Canadian clinical practice and determine the importance of this product as a treatment option for women suffering from uterine fibroids.

Health Canada 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 Department will continue to update Canadians, including healthcare providers, on this important safety issue.

Information for patients:

Information for healthcare providers:

As per the Canadian Product Monograph:

Health Canada is also advising healthcare providers to:

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This content was originally published here.


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