Pharmacovigilance Risk Assessment Committee (PRAC) recommends suspension of ulipristal acetate for uterine fibroids during ongoing EMA review of liver injury risk

The safety committee of the EMA has advised that all women taking 5-mg ulipristal acetate should be advised to stop taking it, whilst a safety review is started following a further report of serious liver injury leading to the need for liver transplantation.

SPS commentary:

In 2018, a EMA review had 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, the EMA is starting a new review.


The MHRA had also issued an alert stating more than one treatment course is authorised only in women who are not eligible for surgery, and liver function monitoring is to be carried out in all women treated with ulipristal.


European Medicines Agency

Resource links:

Link to MHRA Drug Safety Alert (August 2018)