Ulipristal acetate 5mg medicinal products

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

Overview

Suspension of ulipristal acetate for uterine fibroids during ongoing EMA review of liver injury risk

On 12 March 2020, EMA’s safety committee (PRAC) recommended women to stop taking 5-mg ulipristal acetate (Esmya and generic medicines) for uterine fibroids while a safety review is ongoing. No new patients should start treatment with the medicines, which will be temporarily suspended throughout the EU during the review.

EMA is starting its review at the request of the European Commission following a recent case of liver injury, which led to liver transplantation in a patient taking the medicine.

A 2018 EMA review concluded that there is a risk of rare but serious liver injury with ulipristal acetate medicines for the treatment of uterine fibroids, and measures were implemented to minimise the risk. However, as the new case of serious liver injury occurred in spite of adherence to these measures, EMA is starting a new review.

Cases of serious liver injury have been reported, including 5 that led to transplantation, out of over 900,000 patients who have been treated with ulipristal acetate for fibroids since its authorisation in 2012.

Ulipristal acetate is also authorised as a single-dose medicine for emergency contraception. This review does not affect the single-dose ulipristal acetate emergency contraceptive (ellaOne and other trade names) and there is no concern about liver injury with these medicines.

Further information and updated recommendations will be provided once the review is concluded.

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
Procedure started
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

All documents

Procedure started

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

News

How useful was this page?

Add your rating
Average
3 ratings