Medicinal products containing ulipristal acetate for uterine fibroids – EMA recommends restricting use

18.01.2021 3569 views

On 12 November 2020, the CHMP recommended restricting the use of medicinal products containing ulipristal acetate 5 mg (Esmya and generics) due to cases of serious liver injury. These medicinal products may now be used only for the treatment of uterine fibroids in premenopausal women for whom surgical treatment (including uterine fibroid embolization) is not suitable or has failed. The medicinal products must not be used to control the 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 instructions for medical use of ulipristal acetate 5 mg, to the educational materials for doctors and to the patient cards.

The PRAC review of serious liver injury with ulipristal acetate 5 mg found that it is not possible to identify either the patients at greatest risk of liver injury or measures that would help reduce the risk. Therefore, PRAC recommended banning the sale of these medicinal products in the EU.

The CHMP endorsed the PRAC assessment of the risk of liver injury. However, the CHMP considers that the benefit of ulipristal acetate 5 mg in the treatment of uterine fibroids may outweigh the risk in women who have no other treatment options. As a result, the CHMP recommended that the medicine remain available for the treatment of premenopausal women who could not undergo surgery (or in whom surgery was unsuccessful).

Ulipristal acetate is also authorized as a single-dose product for emergency contraception (ellaOne and other trade names). Liver injury has not been a concern with these single-use products for emergency contraception, and this recommendation does not affect them.

The CHMP recommendation was sent to the European Commission, which issued a legally binding decision. The use of ulipristal acetate 5 mg for uterine fibroids was suspended as a precaution pending the results of this review.

Information for patients

the doctor will prescribe ulipristal acetate 5 mg for the treatment of uterine fibroids only if:
- you have not reached menopause;
- you cannot undergo surgical treatment for this condition, or the surgery was unsuccessful;
serious liver injury has been reported in women who used ulipristal acetate 5 mg, which in several cases may lead to liver transplantation. Your doctor will discuss with you whether your need for treatment outweighs this risk;
a blood test to check liver function must be performed before starting ulipristal acetate 5 mg, during treatment and after treatment discontinuation;
read the patient information you received with your medicine ulipristal acetate 5 mg, as it states what to do if you have signs of liver injury;
you must stop treatment with ulipristal acetate 5 mg and immediately see a doctor if signs of liver damage appear (yellowing of the skin, dark urine, nausea or vomiting);
consult your doctor if you have any questions or concerns about your treatment.

Information for healthcare professionals

the medicinal product ulipristal acetate 5 mg should be prescribed only for the treatment of uterine fibroids in premenopausal women who cannot undergo surgery or uterine fibroid embolization, or in whom surgical treatment has been unsuccessful;
use of ulipristal acetate 5 mg is restricted due to reports of serious liver injury, sometimes requiring transplantation;
before starting treatment with ulipristal acetate 5 mg:
- the doctor should discuss all available treatment options with women;
- the physician must counsel the woman on the risk of liver failure and the potential subsequent need for a liver transplant;
although no risk factors for liver injury with the use of ulipristal acetate 5 mg or specific risk-reduction measures have been established, healthcare professionals should follow the instructions for medical use (including contraindications and recommendations on monitoring liver function), as well as the guide for physicians on prescribing these medicines;
patients should be advised to carefully monitor for signs and symptoms of liver injury.

More about the medicinal product

Ulipristal acetate 5 mg was authorized (Esmya and Ulipristal Acetate Gedeon Richter) for the treatment of moderate to severe symptoms of uterine fibroids in women who have not reached menopause. It was used for 3 months before fibroid removal surgery, or for a long time, but with treatment interruptions, in women who could not undergo surgery.

Esmya (ulipristal acetate) was authorized in the EU in 2012. This medicinal product was the subject of a previous review in 2018. Medicinal products containing ulipristal acetate were authorized through national procedures in several EU countries under various trade names.

More about the procedure

The review of the medicinal product Esmya, ulipristal acetate Gedeon Richter and generics was initiated at the request of the European Commission in accordance with Article 31 of Directive 2001/83/EC.

The review was first conducted by the PRAC committee, which made a number of recommendations. The PRAC recommendations were sent to the CHMP committee, which adopted the Agency's opinion. The CHMP opinion was forwarded to the European Commission, which on 11 January 2021 issued a final legally binding decision applicable in all EU Member States.

List of medicinal products containing ulipristal acetate 5 mg and authorized for medical use in Ukraine (according to the State Register of Medicinal Products as of 04.01.2021). (10 KB) (Downloaded: 25.01.2021 08:42:50)