OTTAWA, March 15, 2018 /CNW/ - Health Canada is advising Canadians that it will be conducting a safety review of Fibristal(ulipristal acetate), a medication used to treat uterine fibroids in women. Health Canada's review is a result of Canadian and European reports of serious adverse events affecting the liver.
Fibroids are non-cancerous
The Canadian label for Fibristal was updated in January 2018 to advise Canadians of rare cases of liver injury, including serious liver impairment requiring liver transplants. Since then, additional information on this issue has become available.
Health Canada will review all information available at this time, including scientific and medical literature, along with Canadian and international cases of liver injury. The department will continue to update Canadians, including health professionals, as the review is completed. The Department will take action as needed to optimize the benefits of Fibristal and to reduce the risks associated with it.
Given the potential risk of serious liver injury, patients should discuss any questions or concerns about the use of Fibristal with their healthcare professional.
Interim information for healthcare professionals:
Interim information for patients:
Report health or safety concernsTo report a side effect to a health product to Health Canada:
Stay connected with Health Canada and receive the latest advisories and product recalls using social media tools.
Également disponible en français
SOURCE Health Canada
Subscribe to our Free Newsletters!
Necrotizing fasciitis is a rare life threatening bacterial infection of the tissue below the skin ...
Menstruation or period is the discharge of blood and mucus called menses from the uterus via the ...
Chronic dieting is associated with eating disorders that mainly include unhealthy eating practices ...View All