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Esmya® 5mg Tablets (ulipristal acetate): Women taking Esmya® for uterine fibroids to have regular liver tests while safety review is ongoing; do not initiate treatment in new patients or those who have completed a previous treatment course

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 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.
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    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 ZuelligPharma Sdn. Bhd. in agreement with NPRA to highlight this safety issue. Please refer to this DHPC for further information.