PRAC recommends revoking marketing authorisation of ulipristal acetate for uterine fibroids

Following a review of all the available evidence, PRAC 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, and since it was not possible to identify which patients were most at risk or measures that could reduce the risk, PRAC has concluded that the risks of these medicines outweigh their benefits. PRAC has therefore recommended the revocation of the marketing authorisations of these medicines.

The use of 5-mg ulipristal acetate (Esmya and generic medicines) for uterine fibroids had already been suspended as a precautionary measure while awaiting the outcome of this review. In March 2020, these products were recalled from the Irish market.

The EMA public health communication on the PRAC recommendation is attached to this email and further information on the review can be found here.

The PRAC recommendation will now be forwarded to EMA's human medicines committee (CHMP), which will adopt the Agency's opinion.

Ulipristal acetate is also authorised as a 30-mg single-dose medicine for emergency contraception (ellaOne and other trade names). This suspension and safety review does not affect the 30-mg ulipristal acetate emergency contraceptive and there is no concern to date of liver injury with these medicines.