David Baxter PhD
Late Founder
Health Canada to conduct review of a new potential safety risk of Fibristal (ulipristal acetate), a medication used to treat fibroids
Healthy Canadians - Recalls and Safety Alerts - Health Canada
March 16, 2018
OTTAWA - 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 (benign) tumours of the womb. Fibristal is used for up to three months before women undergo surgery to remove the fibroids. The treatment can also be used long-term in some patients, with a two-month break required between each three-month treatment.
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 patients:
Healthy Canadians - Recalls and Safety Alerts - Health Canada
March 16, 2018
OTTAWA - 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 (benign) tumours of the womb. Fibristal is used for up to three months before women undergo surgery to remove the fibroids. The treatment can also be used long-term in some patients, with a two-month break required between each three-month treatment.
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 patients:
- If you are using Fibristal and have concerns, talk to your doctor.
