Esmya® (ulipristal acetate) for treatment of uterine fibroids: risk of serious liver injury
Active substance ulipristal acetate
03.08.2018 - Conclusion of the procedure
The European risk assessment procedure for Esmya® has been completed following the EU Commission's decision.
This procedure was triggered by reports of severe liver damage, including acute liver failure, in patients treated with Esmya®. The Commission's decision contains indication restrictions, new contraindications and requirements for the necessary monitoring of liver function.
05.06.2018 - CHMP opinion
New measures to minimise risk of rare but serious liver injury
The EMA has concluded its review of the medicinal product for treatment of uterine fibroids.
22.05.2018 – PRAC recommendation
After completion of its review, the PRAC requires regular liver function tests during treatment.
09.02.2018 - Under evaluation
Until the EMA has concluded its review, patients taking Esmya® for treatment of uterine fibroids should have regular liver function tests. No new patients should be started on Esmya®.
01.12.2017 - Procedure started
The European Medicines Agency EMA has initiated a review procedure concerning the medicinal product Esmya® with the active substance ulipristal acetate.
To the risk assessment procedure (available in German only)
For details regarding the procedure please click on the following link to the European Medicines Agency (EMA):