Esmya® 5 mg 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:

 

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.