Health Canada to conduct review of a new potential safety risk of Fibristal (ulipristal acetate), a medication used to treat fibroids
- Starting date:
- March 15, 2018
- Posting date:
- March 15, 2018
- Type of communication:
- Information Update
- Source of recall:
- Health Canada
- Important Safety Information
- General Public
- Identification number:
OTTAWA - Health Canada is advising Canadians that it will be conducting a safety review of Fibristal (ulipristal acetate), a medication used to treat uterine fibroids in women. Health Canada's review is a result of Canadian and European reports of serious adverse events affecting the liver.
Fibroids are non-cancerous (benign) tumours of the womb. Fibristal is used for up to three months before women undergo surgery to remove the fibroids. The treatment 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 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.
Health Canada will review all information available at this time, including scientific and medical literature, along with Canadian and international cases of liver injury. The department will continue to update Canadians, including health professionals, as the review is completed. The Department will take action as needed to optimize the benefits of Fibristal and to reduce the risks associated with it.
Given the potential risk of serious liver injury, patients should discuss any questions or concerns about the use of Fibristal with their healthcare professional.
Interim information for healthcare professionals:
- Before starting patients on Fibristal, evaluate and discuss with them the benefits and risks associated with the medication.
- Do not prescribe Fibristal treatment if your patient has active/concomitant hepatic disease.
- Monitor your patient's liver function at least once a month during their Fibristal treatment and 2-4 weeks after completion of treatment.
- If your patient shows signs or symptoms compatible with liver injury (nausea, vomiting, fatigue, abdominal pain, jaundice), conduct liver function tests on them immediately.
- Advise your patients about the signs and symptoms of liver injury.
Interim information for patients:
- If you are using Fibristal and have concerns, talk to your doctor.
Report health or safety concerns
To report a side effect to a health product to Health Canada:
- Call toll-free at 1-866-234-2345
- Visit Health Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.
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