Summary

• Cases of serious liver injury (including those necessitating liver transplantation) have followed the use of ulipristal acetate 5 mg for treating moderate to severe symptoms of uterine fibroids.
• The use of ulipristal acetate 5 mg must now be considered only for intermittent treatment of moderate to severe symptoms of uterine fibroids in women who have not reached menopause and when uterine fibroid embolisation or surgery are not suitable or have failed.

• The physician must discuss with patients the risks and benefits of available alternatives so patients can make an informed decision.
• The risks of ulipristal acetate 5 mg should be fully explained to patients, especially the risk of liver injury, which could in rare cases lead to liver transplantation.
• Patients should be informed about possible signs and symptoms of liver injury, and if patients get such symptoms, they must stop treatment and contact their doctor immediately.

Background on the safety concern

In 2018, a review of ulipristal acetate 5 mg was carried in the light of reports of four cases of serious liver injury leading to liver transplantation. As a result, several measures were recommended to minimise the risk of serious liver injury, including restriction in indication, a contraindication, and liver function monitoring.

Recently, a new (fifth) case of serious liver injury leading to liver transplantation has been reported. Having ruled out other plausible aetiologies, ulipristal acetate was considered to be the most likely cause of acute hepatitis leading to acute liver failure and liver transplantation.

A second European review concluded that in addition to the previous measures, the indication of ulipristal acetate 5 mg should be further restricted. The risk of severe liver injury does not justify its use for pre-operative treatment of uterine fibroids.

Besides, it is vital to properly and sufficiently communicate the benefits and risks of ulipristal acetate 5 mg to patients – in particular, the risk of liver injury and its possible signs and symptoms, which could in rare cases lead to liver transplantation. If patients experience such symptoms, they should stop treatment, and contact their doctor immediately. Patients should also be informed of the need for liver monitoring before, during and after treatment courses. For this reason, patients should carefully read the patient alert card included in the medicine’s package.

These measures will be introduced in the summary of product characteristics (SmPC) of ulipristal acetate 5 mg. The Physician’s guide and the Patient alert card will also be updated.

Call for reporting

Healthcare professionals should report any adverse reactions associated with the use of ulipristal acetate 5 mg in accordance with the national spontaneous reporting system <include the details (e.g. name, postal address, fax number, website address) on how to access the national spontaneous reporting system>.

Company contact point

Local contact details to be added on a country by country basis.”

Published on: 29 January 2021