TORONTO — Health Canada says a safety review of a drug to treat uterine fibroids in women of childbearing age has found a possible link between its use and the risk of a rare but serious liver injury.
Fibroids are non-cancerous tumours that develop within the muscle tissue of the uterus; many women with fibroids have no symptoms, but in others the growths can cause heavy menstrual bleeding and cramping.
The federal department initiated its review of Fibristal after receiving four international reports of liver injury leading to liver transplants; it has been working with manufacturer Allergan to update safety information for the drug, including new restrictions for its use.
Fibristal should not be used in women who currently have, or have previously had liver problems, and intermittent use should be restricted to women of childbearing age who are not eligible for fibroid-removal surgery.
Patients taking Fibristal who develop symptoms such as fatigue, yellowing of the skin, darkening of the urine, or nausea and vomiting should stop taking the medication and contact their physician immediately.
Health Canada says doctors should not prescribe Fibristal to women with current or previous liver problems and they should advise patients of the need for monitoring their liver function before, during and after treatment.