PRAC calls for revocation of ulipristal authorization for uterine fibroids

4 September 2020

Following its latest monthly meeting, the European Medicines Agency’s Pharmacovigilance Risk Committee (PRAC) has confirmed that 5mg ulipristal acetate (Esmya and generic medicines) used for the treatment of symptoms of uterine fibroids can cause liver injury, including the need for liver transplantation. The PRAC has therefore recommended the revocation of the marketing authorization of these medicines.

The marketing authorization holder for Esmya in Europe is Hungarian drugmaker Gedeon Richter (RICHT: HB).

The PRAC considered all the available evidence in its review, including reported cases of serious liver injury. Patient and healthcare professional representatives, including experts in gynaecology, were also consulted. Since it was not possible to identify which patients were most at risk or measures that could reduce the risk, the PRAC concluded that the risks of these medicines outweighed their benefits and that they should not be marketed in the EU.

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