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Esmya (ulipristal acetate) - MHRA safety alert

Published: 12/02/2018

Updated 8 August 2018

On 7 August 2018, the Medicines & Healthcare products Regulatory Agency (MHRA) wrote to all NHS Trusts in England and the CMOs of Scotland, Wales and Northern Ireland to confirm the restrictions to the use of Esmya (ulipristal acetate) for symptoms of uterine fibroids. This final advice replaces the temporary safety measures announced on 9 February 2018, and is based on completion of an EU review investigating the link between Esmya and cases of serious liver injury.

With immediate effect, Esmya should not be used unless:

  • The new restricted indication is met, and the patient does not have an underlying liver disorder; more than one treatment course is now authorised only in women who are not eligible for surgery
  • Liver function monitoring is performed before, during and after treatment courses
  • The rare risk of liver damage and need for liver function monitoring have been discussed and the patient knows the signs and symptoms of liver injury and what to do if they occur.

Full details of indications and contraindications to Esmya use can be found on the MHRA website, and in the letter from the MHRA to healthcare professionals (PDF, 107kb).

The emergency contraceptive ellaOne also contains ulipristal acetate (single-dose, 30mg). No cases of serious liver injury have been reported with ellaOne and there are no concerns with this medicine at this time. See the statements from the Faculty of Sexual and Reproductive Healthcare on 12 Feb 2018 and 8 Aug 2018.

European Medicines Agency review

Full details of the review into Esmya are available on the European Medicines Agency website.

Call for reporting

Please report suspected adverse drug reactions to the MHRA through the Yellow Card Scheme