Health Canada to review safety of drug to treat fibroids due to liver damage risk

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

Fibristal is used for up to three months before a woman undergoes surgery to remove the non-cancerous 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 says 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.

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