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Review
. 2025 May;48(5):455-488.
doi: 10.1007/s40264-025-01514-z. Epub 2025 Feb 8.

Drug Induced Liver Injury: Highlights and Controversies in the 2023 Literature

Harjit Singh  1 , Bryce F Kunkle  2 , Angela R Troia  2 , Advait M Suvarnakar  3 , Ade C Waterman  2 , Yadana Khin  2 , Serena Y Korkmaz  2 , Corinne E O'Connor  2 , James H Lewis  4
Affiliations
Review

Drug Induced Liver Injury: Highlights and Controversies in the 2023 Literature

Harjit Singh et al. Drug Saf. 2025 May.

Abstract

Drug-induced liver injury (DILI) remains an active field of clinical research and investigation with more than 4700 publications appearing in 2023 relating to hepatotoxicity of all causes and injury patterns. As in years past, we have attempted to identify and summarize highlights and controversies from the past year's literature. Several new and novel therapeutic agents were approved by the US Food and Drug Administration (FDA) in 2023, a number of which were associated with significant hepatotoxicity. Updates in the diagnosis and management of DILI using causality scores as well as newer artificial intelligence-based methods were published. Details of newly established hepatotoxins as well as updated information on previously documented hepatotoxic drugs is presented. Significant updates in treatment of DILI were also included as well as reports related to global DILI registries.

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Conflict of interest statement

Declarations. Funding: Not applicable. No sources of funding were used in the preparation of this article. Conflicts of Interest: J.H.L. is an editorial board member of Drug Safety. J.H.L. was not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions. None of the other authors have any conflicts of interest that are relevant to the content of this article. Ethics Approval: Not applicable. This is a review article with no human participants and no use of biological material or data. Consent to Participate: Not applicable. Consent to Publish: Not applicable. Availability of Data and Materials: Data sharing is not applicable to this article as no datasets were generated or analyzed during the current study. Code Availability: Not applicable. Author Contributions: H.S. and J.H.L. established the project, conducted a thorough literature review, wrote the majority of the final version of the manuscript, and critically revised the manuscript for content. All authors contributed to study conception and design as well as preliminary writing. All authors read and approved the final version.

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References

    1. Li M, Wang Y, Lv TT, et al. Mapping the incidence of drug-induced liver injury: a systematic review and meta-analysis. J Dig Dis. 2023;24(5):332–9. https://doi.org/10.1111/1751-2980.13205 . - DOI - PubMed
    1. Kamimura H, Setsu T, Kimura N, et al. Analysis of drug-induced liver-related adverse event trend reporting between 1997 and 2019. Hepatol Res. 2023;53(6):556–68. https://doi.org/10.1111/hepr.13883 . - DOI - PubMed
    1. Clinton JW, Kiparizoska S, Aggarwal S, Woo S, Davis W, Lewis JH. Drug-induced liver injury: highlights and controversies in the recent literature. Drug Saf. 2021;44(11):1125–49. https://doi.org/10.1007/s40264-021-01109-4 . - DOI - PubMed - PMC
    1. Annual reviews ranking in journal citation reports (clarivate analytics). 2024. https://www.annualreviews.org/about/impact-factors . Accessed 25 Nov 2024.
    1. FDA. Novel Drug Approvals for 2023. 2023. https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and... . Accessed 25 Nov 2024.

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