Posted by Michael Wonder on 01 Oct 2020
Fibristal (ulipristal acetate 5 mg tablets) voluntary withdrawal in Canada due to risk of drug-induced liver injury
30 September 2020 - Allergan is working closely with Health Canada to voluntarily withdraw Fibristal (ulipristal acetate 5 mg tablets) across Canada.
Allergan has reviewed the benefits and risks for Fibristal following reports of rare cases of severe liver injury requiring liver transplantation in Europe and has decided to remove the medication from the Canadian market.
Fibristal is approved in Canada for preoperative treatment of moderate to severe signs and symptoms of uterine fibroids in adult women of reproductive age AND for intermittent treatment of moderate to severe signs and symptoms of uterine fibroids in adult women of reproductive age who are not eligible for surgery.The duration of each Fibristal treatment course is three months.
