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Liver Injury with Ulipristal Acetate: Exploring the Underlying Pharmacological Basis

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  • Milo Gatti

    (University of Bologna)

  • Elisabetta Poluzzi

    (University of Bologna)

  • Fabrizio De Ponti

    (University of Bologna)

  • Emanuel Raschi

    (University of Bologna)

Abstract

Introduction The European Medicines Agency has suspended the use of ulipristal acetate (UPA) in the treatment of uterine fibroids and is reassessing its association with a risk of liver injury. Objectives Our objectives were to characterize the post-marketing reporting of drug-induced liver injury (DILI) with UPA and investigate the underlying pharmacological basis. Methods We queried the worldwide FDA Adverse Event Reporting System and performed a disproportionality analysis, selecting only hepatic designated medical events (DMEs) where UPA was reported as suspect. The reporting odds ratios (RORs) were calculated, and we considered a lower limit of the 95% confidence interval (LL95% CI) > 1 as significant. Physiochemical/pharmacokinetic features were extracted to assess the risk of hepatotoxicity by applying predictive DILI risk models. Mifepristone and leuprolide were selected as comparators. Results A significantly higher proportion of liver disorders was reported for UPA than for mifepristone (2.9 vs. 0.8%; p

Suggested Citation

  • Milo Gatti & Elisabetta Poluzzi & Fabrizio De Ponti & Emanuel Raschi, 2020. "Liver Injury with Ulipristal Acetate: Exploring the Underlying Pharmacological Basis," Drug Safety, Springer, vol. 43(12), pages 1277-1285, December.
    • Handle: RePEc:spr:drugsa:v:43:y:2020:i:12:d:10.1007_s40264-020-00975-8
    DOI: 10.1007/s40264-020-00975-8
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    References listed on IDEAS

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    1. Inge de Milliano & Moniek Twisk & Johannes C Ket & Judith A Huirne & Wouter J Hehenkamp, 2017. "Pre-treatment with GnRHa or ulipristal acetate prior to laparoscopic and laparotomic myomectomy: A systematic review and meta-analysis," PLOS ONE, Public Library of Science, vol. 12(10), pages 1-28, October.
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