EMA’s human medicines committee (CHMP) has recommended restricting use of medicines containing ulipristal acetate 5 mg (Esmya and generic medicines) as a result of cases of serious liver injury. The medicines can now only be used to treat uterine fibroids in premenopausal women for whom surgical procedures (including uterine fibroid embolisation) are not appropriate or have not worked. The medicines must not be used for controlling symptoms of uterine fibroids while awaiting surgical treatment.

Information on the risk of liver failure (requiring liver transplantation in some cases) will be added to the summary of product characteristics and the package leaflets for ulipristal acetate 5 mg medicines as well as in educational material for doctors and cards for patients.

EMA’s safety committee (PRAC) review of serious liver injury with ulipristal acetate 5 mg had found that it was not possible to identify either patients most at risk of liver injury or measures that could reduce the risk. The PRAC had therefore advised that these medicines should not be marketed in the EU.

The CHMP endorsed the PRAC’s assessment of the risk of liver injury. However, it considered that the benefits of ulipristal acetate 5 mg in controlling fibroids may outweigh this risk in women who have no other treatment options. As a result, the CHMP recommended that the medicine remains available to treat premenopausal women who could not have surgery (or for whom surgery had not worked).

Ulipristal acetate is also authorised as a single-dose medicine for emergency contraception (ellaOne and other trade names). No concern has been raised about liver injury with these single-dose emergency contraception medicines and this recommendation does not affect them.

The CHMP recommendation will now be forwarded to the European Commission for its decision. The use of 5-mg ulipristal acetate medicines for uterine fibroids had been suspended as a precaution while awaiting the outcome of this review.

Posted on the EMA website on 13 November 2020