Following four cases of serious liver injury leading to hepatic transplantation and additional cases of hepatic injury reported in patients treated with ulipristal acetate, the Pharmacovigilance Risk Assessment Committee (PRAC) have made the following recommendations which have now been endorsed by the Committee for Medicinal Products for Human Use (CHMP):
Information for healthcare professionals
• Contraindication in patients with underlying liver disorders.• Restricted indication in the intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age: Esmya should only be used in women who are not eligible for surgical treatment. (Esmya continues to be indicated for one course (lasting up to 3 months) of pre-operative treatment for moderate to severe symptoms of uterine fibroids in adult women of reproductive age.)• Liver function tests to be performed before starting each treatment course, monthly during the first 2 treatment courses, and thereafter as clinically indicated. Liver testing also to be performed again 2-4 weeks after stopping treatment.• Esmya should not be started if levels of alanine transaminase (ALT) or aspartate aminotransferase (AST) are more than 2 times the upper limit of normal (ULN).• Treatment should be stopped in patients with ALT or AST levels more than 3 times ULN.• Healthcare professionals should advise their patients about the signs and symptoms of liver injury and the action to take should they occur. In case of signs or symptoms suggestive of such injury, treatment should be stopped. Patients should be investigated immediately including liver function testing.• Healthcare professionals prescribing Esmya in the EU will receive a letter with further details once a European Commission decision has been issued.