PRAC September 2020 – Revocation of marketing authorisation of ulipristal acetate (Esmya) for uterine fibroids

date: 15/09/2020

During its meeting of September 2020, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) recommended the revocation of marketing authorisation of ulipristal acetate for uterine fibroids.

A review by EMA’s safety committee (PRAC) has confirmed that 5-mg 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 authorisations of these medicines.

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.

The use of 5-mg ulipristal acetate medicines for uterine fibroids had already been suspended as a precautionary measure while awaiting the outcome of this review.

Ulipristal acetate is also authorised as a single-dose medicine for emergency contraception. This recommendation does not affect the single-dose ulipristal acetate emergency contraceptive (ellaOne and other trade names) and there is no concern about liver injury with these medicines.

The PRAC recommendation will now be forwarded to EMA’s human medicines committee (CHMP), which will adopt the Agency’s opinion.

The following ulipristal – containing medicines are authorised and marketed in Belgium :

  • Esmya (whose the marketing authorisation is affected by the PRAC recommendation)
  • ellaOne (whose the marketing authorisation is not affected by the PRAC recommendation)

More information is available on the EMA website.

Last updated on 15/09/2020