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Health Canada Health products

FIBRISTAL (ulipristal acetate tablets, 5 mg) - Voluntary Withdrawal in Canada due to Risk of Drug-Induced Liver Injury

Issued September 30, 2020
Issue
Rare cases of liver injury, including cases of serious liver impairment requiring liver transplantation, have been reported internationally in patients using ulipristal acetate tablets, 5 mg. It has been determined that it is not possible to identify which patients are most at risk for developing liver injury, or identify measures that could further reduce the risk. No cases of serious liver impairment leading to transplantation have been reported in Canada.
Hazard description
Product safety