Date: 12 April 2018

Description:

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 two times 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.
• Healthcare professionals should also counsel patients on the signs and symptoms of liver injury. Check transaminase levels immediately if patients develop signs or symptoms consistent with liver injury.

A Direct Healthcare Professional Communication (DHPC) letter has been issued by Zuellig Pharma Sdn. Bhd. in agreement with NPRA to highlight this safety issue. Please refer to this DHPC for further information.