Women taking Ulipristal acetato for uterine fibroids to have regular liver tests while EMA review is ongoing

February 9, 2018 – European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) is currently reviewing the benefits and risks with ulipristal acetato, following reports of serious liver injury, including liver failure leading to transplantation. As a temporary measure while the review is ongoing, the PRAC has recommended regular liver monitoring for women taking ulipristal acetato for uterine fibroids. All women taking ulipristal acetato … (leggi tutto)