Important safety update on potential risk of liver injury with Esmya (Ulipristal Acetate) Tablet 5mg

Zuellig Pharma Pte Ltd would like to update healthcare professionals on the potential risk of liver injury associated with Esmya. In December 2017, the European Medicines Agency Pharmacovigilance Risk Assessment Committee (PRAC) has started a review to assess the link between Esmya and the potential risk of liver injury following four reports of serious liver injury. While PRAC’s review is ongoing, healthcare professionals are advised not to start new patients on Esmya or initiate 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. Please refer to the letter for details.

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg and follow the procedures below to access the MOH Alert system.

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.