PRAC March 2020
Heard from FAMHP
March 24, 2020
Suspension of ulipristal acetate, review of liver injury risk – Testing and treatment recommendations for fluorouracil, capecitabine, tegafur and flucytosine – Review of ifosfamide cancer medicines
During its meeting of March 2020, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) recommended the suspension of ulipristal acetate for uterine fibroids during ongoing review of liver injury risk. Furthermore, the PRAC made new testing and treatment recommendations for fluorouracil, capecitabine, tegafur and flucytosine, and started a review of certain ifosfamide cancer medicines.
Suspension of ulipristal acetate for uterine fibroids during ongoing review of liver injury risk
The PRAC recommends 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 five 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.