Liver Injury with Ulipristal Acetate: Exploring the Underlying Pharmacological Basis

Milo Gatti, Elisabetta Poluzzi, Fabrizio De Ponti () and Emanuel Raschi
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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

Drug Safety, 2020, vol. 43, issue 12, No 9, 1277-1285

Abstract: 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

Date: 2020
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DOI: 10.1007/s40264-020-00975-8

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