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Drug-induced cholestatic hepatitis — Clinical Guidelines

Overview

Drug-induced liver injury (DILI) is an unpredictable condition caused by various medications, herbal products, and dietary supplements 2 4. It presents with diverse clinical and pathological phenotypes and lacks specific biomarkers, making diagnosis challenging and requiring exclusion of other liver disease etiologies 4.

Diagnosis

Diagnosis requires a high degree of awareness and careful exclusion of alternative causes of liver disease 4.

Symptoms may include jaundice, anorexia, and vomiting 3.

Elevated hepatic transaminases are a common finding 3.

Immune-mediated hepatotoxicity (IMH) from immune checkpoint inhibitors (ICIs) can be associated with specific age groups (56-63 years for grade ≥3 IMH) 1.

Management

Discontinuation of the offending agent typically leads to remission of liver injury 3.

No effective therapy has been developed for severe DILI presenting as acute liver failure 4.

Special Populations

Patients aged 56-63 years were significantly associated with the risk of grade ≥3 immune-mediated liver injury (IMH) induced by immune checkpoint inhibitors (ICIs) 1.

Key Recommendations

Immune checkpoint inhibitor (ICI) combination therapy is significantly associated with the risk of all-grade immune-mediated liver injury (IMH) 1. (Evidence: Moderate)

A history of immune checkpoint inhibitor (ICI) treatment is significantly associated with the risk of all-grade immune-mediated liver injury (IMH) 1. (Evidence: Moderate)

Albendazole may induce liver injury, even in small doses, and practitioners and patients should be aware of this risk 3. (Evidence: Weak)

References

1 Wang B, Zhuang S, Lin S, Lin J, Zeng W, Du B et al.. Analysis of risk factors for immune checkpoint inhibitor-associated liver injury: a retrospective analysis based on clinical study and real-world data. Hepatology international 2025. link 2 Segovia-Zafra A, Villanueva-Paz M, Serras AS, Matilla-Cabello G, Bodoque-García A, Di Zeo-Sánchez DE et al.. Control compounds for preclinical drug-induced liver injury assessment: Consensus-driven systematic review by the ProEuroDILI network. Journal of hepatology 2024. link 3 Piloiu C, Dumitrascu DL. Albendazole-Induced Liver Injury. American journal of therapeutics 2021. link 4 . EASL Clinical Practice Guidelines: Drug-induced liver injury. Journal of hepatology 2019. link

Drug-induced cholestatic hepatitis