PRAC recommends new measures to minimise risk of rare but serious liver injury with Ulipristal acetate for fibroids

May 18, 2018 – EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed its review of ulipristal acetate, following reports of serious liver injury. After considering all the evidence, the PRAC concluded that the medicine must not be used in women with liver problems and that certain other patients may start new treatment courses provided they have regular liver tests. Ulipristal acetate is used to treat moderate to severe symptoms of uterine fibroids (benign … (leggi tutto)