Uterine fibroids
RAG rating
Double Red
Document type
Decision document
Hertfordshire and West Essex ICB
Output type
Pharmacy / Prescribing


Ulipristal (Esmya®) for THE TREATMENT OF uterine fibroidsy

NOT Recommended for prescribing – double red

Name: generic (trade) Ulipristal Acetate (Esmya®)

What it is Synthetic selective progesterone receptor modulator

Indication Treatment of moderate to severe symptoms of uterine fibroids

Date decision last revised February 2019 (update March 2021 with revised MHRA Drug Safety Information)

Decision status Final

NICE / SMC Guidance NICE guideline [NG88]– recommended for restricted use, SMC - accepted for restricted use


Ulipristal Acetate (Esmya®) is NOT RECOMMENDED for the treatment of uterine fibroids following the publication of the MHRA Drug Safety Updates (DSUs) (February 2021, March and August 2018):

- Following February 2021 DSU - The indication of ulipristal acetate 5mg for uterine fibroids was further restricted due to the risk of serious liver injury and liver failure, with some cases requiring liver transplantation.

- Previous DSU (March 2018) for Esmya®(ulipristal acetate) for uterine fibroids reported a link with cases of serious liver injury and recommended: do not initiate or re-start treatment; monitor liver function in current and recent users. There was subsequently a local ‘not recommended for prescribing’ recommendation. This DSU was superseded by an updated DSU August 2018.

- An EU review investigating the link between Esmya® and cases of serious liver injury concluded that Esmya®may have contributed to the development of some of the 8 cases of serious liver injury reported for this drug. The review recommended restricting the indicated population for Esmya® for safety reasons and introduced measures to minimise risk of liver injury. Following this an updated DSU (August 2018) was published with new restrictions to use and requirements for liver function monitoring before, during, and after treatment.

- The previous and updated DSU were discussed at the October 2018 and February 2019 HMMC meetings including feedback from local specialists. Concerns were raised about the risks associated with Esmya®including ongoing safety concerns, complexity of monitoring, potential interactions with other liver toxic drugs and that alternative treatment options are available.

It is recommended that Esmya® should remain as ‘double red’ (not recommended for prescribing) and this is supported by local specialists at East and North Hertfordshire NHS Trust, West Hertfordshire Hospitals NHS Trust and Princess Alexandra Hospital Trust.

- The August 2018 DSU includes the following information:


The emergency contraceptive ellaOne also contains ulipristal acetate in a single dose of 30 mg. No cases of serious liver injury have been reported with ellaOne since it was authorised in the EU in 2009 and there are no concerns or changes to its use at this time.

Refer to following links for full details of DSUs:

February 2021: Ulipristal acetate 5mg (Esmya): further restrictions due to risk of serious liver injury - GOV.UK (

August 2018:

March 2018:

Version number
2.1 Harmonisation of Hertfordshire Medicines Management Committee (HMMC) guidance and West Essex Medicines Optimisation Programme Board (WEMOPB) guidance updates include: • Rebadging with HWE ICB and removal of ENHCCG and HVCCG headers • Review date removed and replaced with standard statement.
Developed by
Approved by
Date approved / updated
HMMC March 2021 and WEMOPB March 2018
Review date
The recommendation is based upon the evidence available at the time of publication. This recommendation will be reviewed upon request in the light of new evidence becoming available.
Superseded version