Date: 12 April 2018
The Pharmacovigilance Risk Assessment Committee (PRAC), European Medicines Agency (EMA) started a review of Esmya®, to assess the link between Esmya® and cases of serious liver injury.
While the review is ongoing:
- Healthcare professionals are advised not to start new patients on Esmya®, or new treatment courses in patients who have completed a previous one.
- Liver function tests should be performed at least once a month for all patients on Esmya®. If the transaminase levels increase more than twotimes the upper limit of normal, treatment should be stopped and patient should be monitored closely. Liver function test should be repeated 2-4 weeks after stopping treatment.
A Direct Healthcare Professional Communication (DHPC) letter has been issued by ZuelligPharma Sdn. Bhd. in agreement with NPRA to highlight this safety issue. Please refer to this DHPC for further information.