Flash VIG-news: ESMYA® (ulipristal acetate 5 mg): revocation of the marketing authorisation

After reviewing the benefit-risk ratio of the medicinal product ESMYA®, the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) has recommended the definitive revocation of its marketing authorisation (MA).

ESMYA® was indicated for the treatment of moderate to severe symptoms of uterine fibroids in adult women of childbearing potential.

Following a new case of severe liver damage requiring liver transplantation, despite the risk minimisation measures implemented since 2018, the use of ESMYA® was suspended in Europe in March 2020. Since then, the PRAC has reviewed the benefit-risk balance of this medicinal product.

The PRAC took all available data into account in its assessment. Patient and healthcare professional representatives, including gynaecology experts, were also consulted.

Since it has not been possible to identify the patients most at risk or any measures that may reduce the risk to the liver, the PRAC has concluded that the risks of this medicinal product outweighed its benefits and recommends that the marketing authorisation for ulipristal acetate 5 mg, used for the treatment of symptoms of uterine fibroids, be revoked.

This recommendation does not apply to the single-dose emergency contraceptive ulipristal acetate (ELLAONE®), for which no case of serious liver injury has been reported. There is no cause for concern about liver injury with this medicinal product.

The PRAC recommendations will be submitted for approval to the Committee for Medicinal Products for Human Use (CHMP), which will soon make a final decision at its meeting.

Information for patients treated with ESMYA®
As the use of the medicinal product ESMYA® has been suspended since March 2020, your treatment should already have been changed and you should have been prescribed a liver test.

If you have any ESMYA® tablets left over, do not use them and return them to your pharmacist.

The liver problems observed generally occurred during treatment or, occasionally, in the weeks following discontinuation.

If you have any questions, ask your doctor or pharmacist for advice.

Information for doctors
We would like to remind you that, as of March 2020, it is no longer possible to prescribe ESMYA®. The MA should be permanently withdrawn soon.

If you have not already done so, please contact those of your patients previously treated with ESMYA® to consider an alternative treatment.

The liver problems observed generally occurred during treatment or, occasionally, in the weeks following discontinuation.

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

PRAC recommends revoking marketing authorisation of ulipristal acetate for uterine fibroids

 

Last updated on
28/10/2020