Information Update - Health Canada safety review finds possible link between Fibristal and risk of liver injury
OTTAWA, /CNW/ - Health Canada is informing Canadians that its safety review of Fibristal (ulipristal acetate) found a possible link between its use and the risk of a rare but serious liver injury.
Fibristal is approved in Canada to treat signs and symptoms of a type of non-cancerous tumour in the uterus (fibroids) in women of childbearing age.
The department initiated its safety review after receiving four international reports of liver injury leading to liver transplants.
To support the safe use of this medication, Health Canada has worked with the manufacturer to update the Canadian product safety information for Fibristal.
The product safety information updates include new restrictions for use. In particular, Fibristal should not be used in women who currently have, or have previously had liver problems. Intermittent use (more than one treatment course) should be restricted to women of childbearing age who are not eligible for surgery to remove their fibroids. In addition, the product safety information has been updated to include requirements for liver function monitoring before, during and after treatment.
Health Canada will continue to monitor the use of Fibristal and will take action if new safety risks are identified.
Important safety information for patients:
Important information for healthcare providers:
For more information, please review the Canadian Product Monograph for Fibristal.
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SOURCE Health Canada