FSRH CEU response to European Medicines Agency recommendations regarding use of ulipristal acetate for management of uterine fibroids (February 2018)

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Published on: 1 February 2018

File size: 225kb PDF

File type: Clinical Statements

The European Medicines Agency (EMA) is currently reviewing the safety of use of Esmya® (ulipristal acetate) for management of uterine fibroids. This review follows reports of a very small number of cases worldwide of serious liver injury in women using Esmya. Until the review process is complete, temporary restrictions have been placed on commencing treatment with Esmya and guidelines for monitoring liver function in women already taking Esmya have been introduced. The EMA recommendations are available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2018/02/news_detail_002902.jsp&mid=WC0b01ac058004d5c1

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