Important safety update on risk of liver injury with Esmya (ulipristal acetate)

Zuellig Pharma Pte Ltd would like to update healthcare professionals about the potential risk of liver injury associated with Esmya (ulipristal acetate). In February 2018, the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) started a review of Esmya and the risk of liver injury. While its review was ongoing, healthcare professionals were advised of the interim measures to be taken when prescribing Esmya. These recommendations include not starting new patients on Esmya, or initiating new treatment courses in patients who have already completed their previous treatment courses. For patients on Esmya, healthcare professionals are advised to counsel patients about the signs and symptoms of liver injury. Monthly liver function tests are recommended and treatment should be discontinued if the patient develops transaminase level more than 2 times the upper limit of normal. PRAC has since completed its safety review and its new recommendations are pending the European Commission’s (EC) final legal decision (anticipated by July 2018).  Meanwhile, healthcare professionals are advised that the interim measures as mentioned above still applies and Zuellig Pharma will communicate, as appropriate, to healthcare professionals on the final recommendations regarding the use of Esmya once EC’s decision has been issued. Please refer to the letter for details.