This CAS alert from the MHRA follows a PRAC recommendation. Five reports of serious liver injury, including four cases of hepatic failure needing liver transplantation, have been reported worldwide in women using ulipristal for uterine fibroids.
The detailed safety measures are:
• Do not initiate new treatment courses of ulipristal acetate, including in women who have completed one or more treatment courses previously
• Perform liver function tests at least once a month in all women currently taking ulipristal acetate. Stop ulipristal acetate treatment in any woman who develops transaminase levels more than 2 times the upper limit of normal, closely monitor and refer for specialist hepatology evaluation as clinically indicated. Liver function tests should be repeated in all women 2 to 4 weeks after stopping treatment.
• Check transaminase levels immediately in current or recent users of ulipristal acetate who present with signs or symptoms suggestive of liver injury (such as nausea, vomiting, malaise, right hypochondrial pain, anorexia, asthenia, jaundice). If transaminase levels are more than 2 times the upper limit of normal, stop treatment, closely monitor and refer for specialist hepatology evaluation as clinically indicated.
• Advise women using ulipristal acetate on the signs and symptoms of liver injury.