Posted by Michael Wonder on 04 Sep 2020
PRAC recommends revoking marketing authorisation of ulipristal acetate for uterine fibroids
4 September 2020 - A review by EMA’s safety committee has confirmed that 5 mg ulipristal acetate (Esmya and generic medicines) used for the treatment of symptoms of uterine fibroids can cause liver injury, including the need for liver transplantation.
The PRAC has therefore recommended the revocation of the marketing authorisations of these medicines.
The PRAC considered all the available evidence in its review, including reported cases of serious liver injury. Patient and healthcare professional representatives, including experts in gynaecology, were also consulted.
