EMA concludes review of medicine for uterine fibroids

The European Medicines Agency (EMA) has recommended that several measures be put in place to minimise the risk of rare but serious liver injury with Esmya (ulipristal acetate). Certain women may start treatment with Esmya once the new measures are implemented.

The measures include: contraindication in women with known liver problems; liver tests before, during and after stopping treatment; a card for patients to inform them about the need for liver monitoring and to contact their doctor should they develop symptoms of liver injury. In addition, use of the medicine for more than one treatment course has been restricted to women who are not eligible for surgery.

Esmya is used to treat moderate to severe symptoms of uterine fibroids (benign tumours of the womb). The medicine has been shown to be effective at reducing bleeding and anaemia associated with the condition, as well as the size of the fibroids.

The review of Esmya was carried out by EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) following reports of serious liver injury, including liver failure leading to transplantation. The PRAC concluded that Esmya may have contributed to the development of some cases of serious liver injury.

The PRAC therefore recommended that use of the medicine should be restricted. It also recommended that studies should be performed to determine the effects of Esmya on the liver and whether the new measures are effective in minimising the risks.

The PRAC’s recommendations have now been endorsed by EMA’s Committee for Medicinal Products for Human Use (CHMP) and will be sent to the European Commission for a final legal decision. A letter will be sent to doctors to inform them of the new conditions of use, which will become applicable after a Commission decision is issued.

Posted on the EMA website on 1 June 2018