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 noncancerous tumors that develop inside the muscular tissue of the uterus; many women with fibroids do not have symptoms, but in others, growths can cause heavy menstrual bleeding and cramps.
The federal department began its review of Fibristal after receiving four international reports of liver damage that led to liver transplants; It has worked with the manufacturer Allergan to update the safety information for the drug, including new restrictions on its use.
Fibristal should not be used in women who currently have or have had liver problems, and intermittent use should be restricted to women of childbearing potential 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, nausea and vomiting should stop taking the medication and contact their doctor immediately.
Health Canada says doctors should not prescribe Fibristal for women with current or previous liver problems and should advise patients on the need to monitor their liver function before, during and after treatment.