Update on ulipristal acetate: Voluntary Withdrawal in Canada due to Risk of Drug-Induced Liver Injury

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.

  • Following rare international cases of severe liver injury requiring liver transplantation, the manufacturer of FIBRISTAL, Allergan Inc., is voluntarily withdrawing the product from the Canadian market. FIBRISTAL was approved in Canada to treat signs and symptoms of uterine fibroids in women of reproductive age.
  • On September 24, 2020, Allergan Inc. initiated the recall of FIBRISTAL from the Canadian market to the retail pharmacy level.

Healthcare professionals are advised to:

  • not prescribe or dispense FIBRISTAL
  • contact patients under their care who are currently being treated with FIBRISTAL to stop treatment, and review alternative treatment options
  • advise patients who have been taking FIBRISTAL to immediately contact a healthcare professional if they experience signs and symptoms of liver injury such as nausea, vomiting, stomach ache, severe tiredness, yellowing of the eyes or skin, or dark urine, which could occur after stopping treatment
  • perform liver function monitoring within 2-4 weeks after treatment with FIBRISTAL has stopped and investigate further if liver function is abnormal

To read the full Health Canada advisory please click here. https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2020/74063a-eng.php