Health Canada is advising Canadians that they will begin a safety review of a medication used to treat uterine fibroids in women called Fibristal.
Fibristal is typically used for up to three months before women undergo surgery to remove fibroids, which are non-cancerous tumours, in the womb. It is also sometimes used on a long-term basis.
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, says Health Canada.
Health Canada says it will take action as needed to optimize the benefits of Fibristal and to reduce the risks associated with it.
Health Canada advises people taking Fibristal to discuss any questions or concerns about the use of it with their healthcare professional. Doctors are being advised to discuss risks and benefits of the medication and to monitor the liver function of patients who are taking it on a monthly basis.
