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

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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.
  •  

    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.

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

DISCLAIMER

The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

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