EMA’s safety committee (PRAC) has recommended women to stop taking 5-mg ulipristal acetate (Esmya and generic medicines) for uterine fibroids while a safety review is ongoing. No new patients should start treatment with the medicines, which will be temporarily suspended throughout the EU during the review.
EMA is starting its review at the request of the European Commission following a recent case of liver injury, which led to liver transplantation in a patient taking the medicine.
A 2018 EMA review concluded that there is a risk of rare but serious liver injury with ulipristal acetate medicines for the treatment of uterine fibroids, and measures were implemented to minimise the risk. However, as the new case of serious liver injury occurred in spite of adherence to these measures, EMA is starting a new review.
Cases of serious liver injury have been reported, including 5 that led to transplantation, out of over 900,000 patients who have been treated with ulipristal acetate for fibroids since its authorisation in 2012.
Ulipristal acetate is also authorised as a single-dose medicine for emergency contraception. This review does not affect the single-dose ulipristal acetate emergency contraceptive (ellaOne and other trade names) and there is no concern about liver injury with these medicines.
Further information and updated recommendations will be provided once the review is concluded.