Esmya

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Summary

 

Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing

No new patients should start treatment for the time being

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) is currently reviewing the benefits and risks with Esmya, following reports of serious liver injury, including liver failure leading to transplantation.

As a temporary measure while the review is ongoing, the PRAC has recommended regular liver monitoring for women taking Esmya for uterine fibroids.

All women taking Esmya should have a liver function test at least once a month during treatment. If the test is abnormal (liver enzyme levels more than 2 times the upper limit of normal), the healthcare professional should stop treatment and closely monitor the patient. Liver tests should be repeated 2 to 4 weeks after stopping treatment.

The PRAC is also recommending that no new patients should be started on Esmya and no patients who have completed a course of treatment should start another one for the time being.

A link between Esmya and cases of serious liver injury is under review. These recommendations are temporary measures to protect patients’ health, pending the conclusion of the review of Esmya which started 30 November 2017.

Information for patients
  • Esmya, used to treat uterine fibroids, is being reviewed because cases of serious liver problems have occurred in women taking the medicine.
  • As a precaution, while taking Esmya you will be required to have blood tests to check that your liver is working well. If the tests indicate that you have a liver problem, your treatment will be stopped.
  • If you have nausea (feeling sick), vomiting, upper belly pain, lack of appetite, tiredness or yellowing of the eyes or skin, contact your doctor immediately as these could be signs of liver problems.
  • If you were about to start treatment with Esmya or start a new course of treatment, your doctor will put your treatment on hold until EMA’s review of the medicine is complete.

If your treatment is stopped, your doctor will check how well your liver is working 2 to 4 weeks after you stop taking Esmya.

Information for healthcare professionals

Following reports of liver injury and hepatic failure with Esmya, EMA has made the following temporary recommendations:

  • Do not start new patients on Esmya or new treatment courses in patients who have already completed a previous one.
  • Perform liver function tests at least once a month for all patients taking Esmya. If the patient develops transaminase levels more than 2 times the upper limit of normal, stop treatment and monitor the patient closely. Liver test should be repeated 2 to 4 weeks after stopping treatment.
  • For any patient with signs or symptoms consistent with liver injury (such as nausea, vomiting, right hypochondrial pain, anorexia, asthenia, jaundice), check transaminase levels immediately. If transaminase levels are more than 2 times the upper limit of normal, stop treatment and closely monitor the patient.
  • Advise your patients about the signs and symptoms of liver injury.

These recommendations are temporary measures, pending the conclusion of an ongoing EMA review of Esmya. Healthcare professionals prescribing Esmya in the EU will receive a letter with further details.

More about the medicine

Esmya was authorised in the EU in 2012 for the treatment of moderate to severe symptoms of uterine fibroids, which are non-cancerous (benign) tumours of the womb, in women who have not reached the menopause. It is used for up to 3 months before women undergo surgery to remove the fibroids and can also be used long-term but with treatment breaks in other women.

The active substance in Esmya, ulipristal acetate, works by attaching to the targets on cells (receptors) that the hormone progesterone normally attaches to, preventing progesterone from having its effect. Since progesterone may promote the growth of fibroids, by preventing the effects of progesterone ulipristal acetate reduces the size of the fibroids.

More information on Esmya is available.

Ulipristal acetate is also the active substance of a single-dose medicine authorised for emergency contraception, ellaOne. No cases of serious liver injury have been reported with ellaOne and there are no concerns with this medicine at this time.

More about the procedure

The review of Esmya was initiated at the request of European Commission on 30 November 2017, under Article 20 of Regulation (EC) No 726/2004.

The review is being carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which will make a set of recommendations.

On 8 February 2018, while the review was ongoing, the PRAC issue temporary recommendations.

The PRAC’s final recommendations will be forwarded to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which will adopt an opinion. The final stage of the review procedure is the adoption by the European Commission of a legally binding decision applicable in all EU Member States.

Name Language First published Last updated
Esmya Article-20 procedure - Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing BG = bălgarski 2018-02-09 2018-03-09
Esmya Article-20 procedure - Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing ES = español 2018-02-09 2018-03-09
Esmya Article-20 procedure - Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing CS = čeština 2018-02-09 2018-03-09
Esmya Article-20 procedure - Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing DA = dansk 2018-02-09 2018-03-09
Esmya Article-20 procedure - Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing DE = Deutsch 2018-02-09 2018-03-09
Esmya Article-20 procedure - Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing ET = eesti keel 2018-02-09 2018-03-09
Esmya Article-20 procedure - Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing EL = elliniká 2018-02-09 2018-03-09
Esmya Article-20 procedure - Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing EN = English 2018-02-09 2018-03-09
Esmya Article-20 procedure - Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing FR = français 2018-02-09 2018-03-09
Esmya Article-20 procedure - Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing IT = italiano 2018-02-09 2018-03-09
Esmya Article-20 procedure - Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing LV = latviešu valoda 2018-02-09 2018-03-09
Esmya Article-20 procedure - Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing LT = lietuvių kalba 2018-02-09 2018-03-09
Esmya Article-20 procedure - Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing HU = magyar 2018-02-09 2018-03-09
Esmya Article-20 procedure - Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing MT = Malti 2018-02-09 2018-03-09
Esmya Article-20 procedure - Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing NL = Nederlands 2018-02-09 2018-03-09
Esmya Article-20 procedure - Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing PL = polski 2018-02-09 2018-03-09
Esmya Article-20 procedure - Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing PT = português 2018-02-09 2018-03-09
Esmya Article-20 procedure - Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing RO = română 2018-02-09 2018-03-09
Esmya Article-20 procedure - Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing SK = slovenčina 2018-02-09 2018-03-09
Esmya Article-20 procedure - Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing SL = slovenščina 2018-02-09 2018-03-09
Esmya Article-20 procedure - Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing FI = suomi 2018-02-09 2018-03-09
Esmya Article-20 procedure - Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing SV = svenska 2018-02-09 2018-03-09
Esmya Article-20 procedure - Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing HR = Hrvatski 2018-02-09 2018-03-09

Key facts

About this medicine

Approved nameEsmya
International non-proprietary name (INN) or common name

ulipristal acetate

Associated names
Class

About this procedure

Current statusUnder evaluation
Reference numberEMEA/H/A-20/1460/C/2041/0043
TypeArticle 20 procedures

This type of procedure is triggered for medicines that have been authorised via the centralised procedure in case of manufacturing or safety issues.

Decision making modelPRAC-CHMP-EC
Authorisation modelCentrally authorised product(s)

Key dates and outcomes

Procedure start date30/11/2017
PRAC recommendation date09/02/2018
OutcomeRisk minimisation measures

All documents

Procedure started

Name Language First published Last updated
Esmya Article-20 procedure - Timetable for the procedure HR = Hrvatski 2017-12-01 2018-04-13
Esmya Article-20 procedure - PRAC list of questions HR = Hrvatski 2017-12-01  
Esmya Article-20 procedure - Notification HR = Hrvatski 2017-12-01  
Esmya Article-20 procedure - Review started HR = Hrvatski 2017-12-01  

Under evaluation

Name Language First published Last updated
Esmya Article-20 procedure - Annex I-II-III HR = Hrvatski 2018-02-09 2018-02-20
Esmya Article-20 procedure - Scientific conclusions HR = Hrvatski 2018-02-21  
Esmya Article-20 procedure - Scientific conclusions HR = Hrvatski 2018-02-21  
Esmya Article-20 procedure - Scientific conclusions HR = Hrvatski 2018-02-21  
Esmya Article-20 procedure - Scientific conclusions HR = Hrvatski 2018-02-21  
Esmya Article-20 procedure - Scientific conclusions HR = Hrvatski 2018-02-21  
Esmya Article-20 procedure - Scientific conclusions HR = Hrvatski 2018-02-21  
Esmya Article-20 procedure - Scientific conclusions HR = Hrvatski 2018-02-21  
Esmya Article-20 procedure - Scientific conclusions HR = Hrvatski 2018-02-21  
Esmya Article-20 procedure - Scientific conclusions HR = Hrvatski 2018-02-21  
Esmya Article-20 procedure - Scientific conclusions HR = Hrvatski 2018-02-21  
Esmya Article-20 procedure - Scientific conclusions HR = Hrvatski 2018-02-21  
Esmya Article-20 procedure - Scientific conclusions HR = Hrvatski 2018-02-21  
Esmya Article-20 procedure - Scientific conclusions HR = Hrvatski 2018-02-21  
Esmya Article-20 procedure - Scientific conclusions HR = Hrvatski 2018-02-21  
Esmya Article-20 procedure - Scientific conclusions HR = Hrvatski 2018-02-21  
Esmya Article-20 procedure - Scientific conclusions HR = Hrvatski 2018-02-21  
Esmya Article-20 procedure - Scientific conclusions HR = Hrvatski 2018-02-21  
Esmya Article-20 procedure - Scientific conclusions HR = Hrvatski 2018-02-21  
Esmya Article-20 procedure - Scientific conclusions HR = Hrvatski 2018-02-21  
Esmya Article-20 procedure - Scientific conclusions HR = Hrvatski 2018-02-21  
Esmya Article-20 procedure - Scientific conclusions HR = Hrvatski 2018-02-21  
Esmya Article-20 procedure - Scientific conclusions HR = Hrvatski 2018-02-21  
Esmya Article-20 procedure - Scientific conclusions HR = Hrvatski 2018-02-21  
Esmya Article-20 procedure - Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing HR = Hrvatski 2018-02-09 2018-03-09
Esmya Article-20 procedure - Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing HR = Hrvatski 2018-02-09 2018-03-09
Esmya Article-20 procedure - Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing HR = Hrvatski 2018-02-09 2018-03-09
Esmya Article-20 procedure - Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing HR = Hrvatski 2018-02-09 2018-03-09
Esmya Article-20 procedure - Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing HR = Hrvatski 2018-02-09 2018-03-09
Esmya Article-20 procedure - Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing HR = Hrvatski 2018-02-09 2018-03-09
Esmya Article-20 procedure - Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing HR = Hrvatski 2018-02-09 2018-03-09
Esmya Article-20 procedure - Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing HR = Hrvatski 2018-02-09 2018-03-09
Esmya Article-20 procedure - Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing HR = Hrvatski 2018-02-09 2018-03-09
Esmya Article-20 procedure - Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing HR = Hrvatski 2018-02-09 2018-03-09
Esmya Article-20 procedure - Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing HR = Hrvatski 2018-02-09 2018-03-09
Esmya Article-20 procedure - Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing HR = Hrvatski 2018-02-09 2018-03-09
Esmya Article-20 procedure - Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing HR = Hrvatski 2018-02-09 2018-03-09
Esmya Article-20 procedure - Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing HR = Hrvatski 2018-02-09 2018-03-09
Esmya Article-20 procedure - Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing HR = Hrvatski 2018-02-09 2018-03-09
Esmya Article-20 procedure - Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing HR = Hrvatski 2018-02-09 2018-03-09
Esmya Article-20 procedure - Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing HR = Hrvatski 2018-02-09 2018-03-09
Esmya Article-20 procedure - Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing HR = Hrvatski 2018-02-09 2018-03-09
Esmya Article-20 procedure - Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing HR = Hrvatski 2018-02-09 2018-03-09
Esmya Article-20 procedure - Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing HR = Hrvatski 2018-02-09 2018-03-09
Esmya Article-20 procedure - Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing HR = Hrvatski 2018-02-09 2018-03-09
Esmya Article-20 procedure - Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing HR = Hrvatski 2018-02-09 2018-03-09
Esmya Article-20 procedure - Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing HR = Hrvatski 2018-02-09 2018-03-09
Esmya Article-20 procedure - Assessment report on provisional measures HR = Hrvatski 2018-02-21  

Document description:

  • Annex I - List of the medicines affected by the referral
  • Annex II - Scientific conclusions of the Committee for Medicinal Products for Human Use (CHMP) or Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh)
  • Annex III - Changes to the summary of product characteristics, labelling or package leaflet - available when the CHMP or CMDh recommends changes to the product information. Also includes conditions for lifting of suspensions, if applicable
  • Annex IV - Conditions of the marketing authorisation - available when the CHMP or CMDh recommends other measures to be taken for the marketing authorisation such as safety measures or additional studies
  • Notification - A letter from a Member State, the European Commission or a marketing-authorisation holder requesting the initiation of a referral procedure
  • Rationale for triggering - Background provided by the party triggering the referral explaining the issues leading to the initiation of the procedure
  • PRAC list of questions - Questions agreed by the PRAC requesting further information to evaluate the issues identified
  • PRAC timetable - Timeframe agreed by the PRAC to receive information, assess the issues and adopt a recommendation
  • PRAC / CHMP / CMDh assessment report - The assessment and conclusions of the PRAC and CHMP or CMDh on the issues investigated

Current status:
Under evaluation