Safety review ordered for fibroid medication

OTTAWA — Health Canada is conducting a safety review of a medication used to treat uterine fibroids in women after reports of serious adverse events affecting the liver.

Fibristal is used for up to three months before a woman has surgery to remove the noncancerous growths in the womb.

The drug, known generically as ulipristal acetate, 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 to advise consumers about rare cases of liver injury, including serious liver impairment requiring a transplant.

But Health Canada said additional information has since become available, prompting the review that will look at scientific literature related to Fibristal and Canadian and international cases of liver injury.

Given the potential risk of serious liver injury, patients should discuss any concerns about use of the drug with their health-care provider, the federal department said.

Symptoms of liver injury include nausea, vomiting, fatigue, abdominal pain and jaundice.

Health-care practitioners are advised not to prescribe Fibristal if a patient has active liver disease.

In those prescribed the medication, liver function should be tested at least once a month during treatment, and two to four weeks after the drug is stopped.