PRAC Recommends Suspension of Ulipristal Acetate for Uterine Fibroids

The Pharmacovigilance Risk Assessment Committee (PRAC) of EMA has recommended that women stop taking 5-mg ulipristal acetate (Esmya and generic medicines) for the treatment of uterine fibroids while a safety review into potential liver injury risk is performed.

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has recommended that women stop taking 5-mg ulipristal acetate (Esmya and generic medicines) for the treatment of uterine fibroids while a safety review into potential liver injury risk is performed.

In a March 13, 2020 press release, EMA announced it is commencing a review of the treatment at the request of the European Commission as a result of a recent case of liver injury that resulted in a liver transplant. A review of the medicine was performed in 2018, when it was deemed that there was a rare but serious risk of liver injury with ulipristal acetate, and measures were taken to minimize the risk. However, as the latest injury has occurred despite the measures being in place, a new review is being started.

As part of the recommendation, all women taking the medicine for the treatment of uterine fibroids should stop taking the drug immediately and no new patients should be started on the treatment, which will be suspended on a temporary basis while the review is being performed. The recommendation does not affect the single-dose ulipristal acetate emergency contraceptive (ellaOne and other trade names).

Source: EMA