Ulipristal acetate 5mg medicinal products

  • Procedure started
  • Under evaluation
  • PRAC recommendation
  • CHMP opinion
  • European Commission final decision
Current status:
European Commission final decision

Overview

Ulipristal acetate for uterine fibroids: EMA recommends restricting use

On 12 November 2020, EMA’s human medicines committee (CHMP) recommended restricting use of medicines containing ulipristal acetate 5 mg (Esmya and generic medicines) as a result of cases of serious liver injury. The medicines can now only be used to treat uterine fibroids in premenopausal women for whom surgical procedures (including uterine fibroid embolisation) are not appropriate or have not worked. The medicines must not be used for controlling symptoms of uterine fibroids while awaiting surgical treatment.

Information on the risk of liver failure (requiring liver transplantation in some cases) will be added to the summary of product characteristics and the package leaflets for ulipristal acetate 5 mg medicines as well as in educational material for doctors and cards for patients.

EMA’s safety committee (PRAC) review of serious liver injury with ulipristal acetate 5 mg had found that it was not possible to identify either patients most at risk of liver injury or measures that could reduce the risk. The PRAC had therefore advised that these medicines should not be marketed in the EU.

The CHMP endorsed the PRAC’s assessment of the risk of liver injury. However, it considered that the benefits of ulipristal acetate 5 mg in controlling fibroids may outweigh this risk in women who have no other treatment options. As a result, the CHMP recommended that the medicine remains available to treat premenopausal women who could not have surgery (or for whom surgery had not worked).

Ulipristal acetate is also authorised as a single-dose medicine for emergency contraception (ellaOne and other trade names). No concern has been raised about liver injury with these single-dose emergency contraception medicines and this recommendation does not affect them.

The CHMP’s recommendation was sent to the European Commission which has issued a legally binding decision. The use of 5-mg ulipristal acetate medicines for uterine fibroids had been suspended as a precaution while awaiting the outcome of this review.

Information for patients

  • Your doctor will prescribe ulipristal acetate 5 mg medicine for treating uterine fibroids (growths in the womb that are not cancerous) only if:
    • you have not reached the menopause and
    • you cannot have an operation for the condition or the operation has not worked.
  • Serious liver injury has occurred in women taking ulipristal acetate 5 mg, which can lead to liver transplantation in a few cases. Your doctor will discuss with you whether your need for treatment outweighs this risk.
  • You will have a blood test to check your liver before you take ulipristal acetate 5 mg, during your treatment and after your treatment stops.
  • Read the card you have been given with your ulipristal acetate 5 mg medicine because it tells you what to do if you have any signs of liver injury.
  • You must stop treatment with ulipristal acetate 5 mg and speak with your doctor immediately if you get any signs of liver injury such as yellowing of the skin, dark urine, feeling sick or vomiting.
  • Speak to your doctor or pharmacist if you have any questions and concerns about your treatment.

Information for healthcare professionals

  • Ulipristal acetate 5 mg medicine must only be prescribed for treating uterine fibroids in premenopausal women who cannot have surgery or uterine fibroid embolisation, or the surgical procedure has failed.
  • Use of ulipristal acetate 5 mg is restricted because of reports of serious liver injury, occasionally requiring liver transplantation.
  • Before treatment with ulipristal acetate 5 mg:
    • prescribers should discuss all available treatment options with women
    • prescribers should counsel women on the risk of liver failure and subsequent need for liver transplantation.
  • Although risk factors for liver injury with ulipristal acetate 5 mg or specific measures to reduce risk have not been identified, healthcare professionals should follow the summary of product characteristics (including contraindications and recommendations on liver function monitoring) as well as the physician’s guide to prescribing that is available for the medicine.
  • Patients should be advised to monitor for signs and symptoms of liver damage.

Key facts

About this medicine
Approved name
Ulipristal acetate 5mg medicinal products
International non-proprietary name (INN) or common name

Ulipristal acetate

Associated names
  • Esmya
  • Ulipristal Acetate Gedeon Richter
Class
Progesterone receptor modulators
About this procedure
Current status
European Commission final decision
Reference number
EMEA/H/A-31/1496
Type
Article 31 referrals

This type of referral is triggered when the interest of the Union is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.

Decision making model
PRAC-CHMP-EC
Authorisation model
Centrally and nationally authorised products (mixed)
Key dates and outcomes
Procedure start date
12/03/2020
PRAC recommendation date
04/09/2020
CHMP opinion/CMDh position date
12/11/2020
EC decision date
11/01/2021

All documents

Procedure started

Under evaluation

Recommendation provided by Pharmacovigilance Risk Assessment Committee

Opinion provided by Committee for Medicinal Products for Human Use

European Commission final decision

  • List item

    Ulipristal acetate 5mg medicinal products Article-31 referral - Ulipristal acetate for uterine fibroids: EMA recommends restricting use (PDF/139.19 KB)


    First published: 13/11/2020
    Last updated: 14/01/2021
    EMA/24778/2021

  • List item

    Ulipristal acetate 5mg medicinal products Article-31 referral - Annex IV (PDF/143.66 KB)


    First published: 03/02/2021

  • List item

    Ulipristal acetate 5mg medicinal products Article-31 referral - Annex III (PDF/154.17 KB)


    First published: 03/02/2021

  • List item

    Ulipristal acetate 5mg medicinal products Article-31 referral - Annex II (PDF/239.8 KB)


    First published: 03/02/2021

  • List item

    Ulipristal acetate 5mg medicinal products Article-31 referral - Annex I (PDF/143.5 KB)


    First published: 03/02/2021

  • List item

    Ulipristal acetate 5mg medicinal products Article-31 referral - CHMP scientific conclusions and PRAC assessment report (PDF/617.57 KB)

    Adopted

    First published: 14/01/2021
    EMA/524073/2020

  • Document description

    • Annex I - List of the medicines affected by the referral
    • Annex II - Scientific conclusions of the CHMP or 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 or CMDh assessment report - The assessment and conclusions of the PRAC and CHMP or CMDh on the issues investigated

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