Ulipristal acetate 5mg medicinal products - referral
Current status
Referral
Human
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
Information for healthcare professionals
Ulipristal acetate 5 mg was authorised (as Esmya and Ulipristal Acetate Gedeon Richter) for treating moderate to severe symptoms of uterine fibroids (non-cancerous tumours of the womb) in women who had not reached the menopause. It was used either for up to 3 months before surgery to remove the fibroids or over the long-term but with treatment breaks in women who could not have surgery.
Esmya (ulipristal acetate) was authorised throughout the EU in 2012. It was the subject of a previous review in 2018. Ulipristal Acetate Gedeon Richter was authorised throughout the EU in 2018. Generic ulipristal acetate medicines have been authorised via national procedures in several EU countries under various trade names.
The review of Esmya, Ulipristal Acetate Gedeon Richter and generics was initiated at the request of the European Commission, under Article 31 of Directive 2001/83/EC.
The review was first carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations.
The PRAC recommendations were sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency’s opinion. The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 11 January 2021.
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.
Description of documents published
Please note that some of the listed documents apply only to certain procedures.
Note that older documents may have different titles.