EMA Communication: PRAC starts review of Esmya for treatment of uterine fibroids

06/12/2017 - 11:35


The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has started a review of Esmya (ulipristal acetate), a medicine used to treat uterine fibroids (non-cancerous tumours of the womb). This follows four reports of serious liver injury, three of which ended in liver transplantation, in patients treated with this medicine.

Given the seriousness of the observed liver injury and its possible link to the medicine, a more in depth review is warranted. The PRAC will now evaluate all available data and determine whether there are any implications for the use of Esmya.

While the review is ongoing, patients should contact their doctor if they have any questions or concerns about their treatment.

Ulipristal acetate is also the active substance of a single-dose medicine authorised for emergency contraception, ellaOne. No cases of serious liver injury have been reported with ellaOne and there are no concerns with this medicine at this time.

The press release is available by clicking here.



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