Esmya (ulipristal acetate) and risk of serious liver injury

Zuellig Pharma Pte Ltd would like to update healthcare professionals on the risk of serious liver injury associated with the use of Esmya (ulipristal acetate). Cases of serious liver injury had been reported overseas in patients treated with Esmya. The European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) concluded from its review that Esmya may have contributed to the development of some cases of serious liver injury. To minimise the risk of serious liver injury associated with the use of Esmya, Zuellig Pharma will be updating the local package insert of Esmya to include warnings on this risk and to inform of the need for liver function monitoring before, during and after treatment with Esmya. The indications for use will also be revised to highlight that Esmya should only be used for the intermittent treatment of moderate to severe symptoms of uterine fibroids, in women of reproductive age who are not eligible for surgical treatment. Esmya continues to be indicated for one treatment course of pre-operative treatment of moderate to severe symptoms of uterine fibroids in women of reproductive age. Please refer to the letter for details.