Association of high risk of liver fibrosis in patients with serious outcomes of adverse drug reactions

Metabolic dysfunction–associated steatotic liver disease (MASLD) as the main cause of chronic liver disease worldwide is associated with increased mortality. Especially in patients with fibrosis, an increased risk of adverse drug reactions (ADRs) might be present. Therefore, the impact of high-risk for liver fibrosis on the outcome of ADRs was analyzed. Patients of a multicenter cohort study in maximum care emergency departments (ED) with admissions due to ADRs with available FIB-4 score parameters were analyzed. The cohort was divided into patients with low (FIB-4 < 2.67) and high (FIB-4 ≥ 2.67) liver fibrosis risk. Triage at ED admission, ADR seriousness criteria, discharge status, and length of hospital stay were used as outcomes. Logistic and linear regression analyses were applied. Among the 1087 patients, 407 had a high risk of fibrosis (37.4%). High risk of fibrosis was associated with serious ADRs (OR 2.42 (95% CI 1.57–3.73)), a poor discharge status including deaths (3.51 (2.20–5.60)), and a longer stay in the hospital (2.02 (1.00–3.05)), while urgent triage at ED admission was not significantly associated with high fibrosis risk (0.95 (0.71–1.28)). In patients at risk of MASLD, careful risk assessment is essential when prescribing drugs, as serious ADRs may occur unnoticed in the presence of liver fibrosis. Even simple non-invasive tests like the FIB-4 score may provide valuable prognostic hints in the acute event of an ADR.

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Publication Details

Journal
European Journal of Clinical Pharmacology
Published
2026-04-23
DOI
https://doi.org/10.1007/s00228-026-04057-z
Primary Topic
Drug-Induced Hepatotoxicity and Protection
Type
article
Field-Weighted Citation Impact
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article

Association of high risk of liver fibrosis in patients with serious outcomes of adverse drug reactions

Anja Knüppel-Ruppert, Corinna Meeßen, Katja Susanne Just, Harald Dormann et al.
European Journal of Clinical Pharmacology
Drug-Induced Hepatotoxicity and Protection
article

Association of high risk of liver fibrosis in patients with serious outcomes of adverse drug reactions

Anja Knüppel-Ruppert, Corinna Meeßen, Katja Susanne Just, Harald Dormann, Joana Henze, Andrea Kriegisch‐Stumpf, Julia Stingl, Matthias Schwab, Carolin V. Schneider
article en

Abstract

Metabolic dysfunction–associated steatotic liver disease (MASLD) as the main cause of chronic liver disease worldwide is associated with increased mortality. Especially in patients with fibrosis, an increased risk of adverse drug reactions (ADRs) might be present. Therefore, the impact of high-risk for liver fibrosis on the outcome of ADRs was analyzed. Patients of a multicenter cohort study in maximum care emergency departments (ED) with admissions due to ADRs with available FIB-4 score parameters were analyzed. The cohort was divided into patients with low (FIB-4 < 2.67) and high (FIB-4 ≥ 2.67) liver fibrosis risk. Triage at ED admission, ADR seriousness criteria, discharge status, and length of hospital stay were used as outcomes. Logistic and linear regression analyses were applied. Among the 1087 patients, 407 had a high risk of fibrosis (37.4%). High risk of fibrosis was associated with serious ADRs (OR 2.42 (95% CI 1.57–3.73)), a poor discharge status including deaths (3.51 (2.20–5.60)), and a longer stay in the hospital (2.02 (1.00–3.05)), while urgent triage at ED admission was not significantly associated with high fibrosis risk (0.95 (0.71–1.28)). In patients at risk of MASLD, careful risk assessment is essential when prescribing drugs, as serious ADRs may occur unnoticed in the presence of liver fibrosis. Even simple non-invasive tests like the FIB-4 score may provide valuable prognostic hints in the acute event of an ADR.

European Journal of Clinical PharmacologyVol. 82(5)
Heidelberg University (DE), University Hospital Heidelberg (DE), Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology (DE), Klinikum Ingolstadt (DE), Klinikum Fürth (DE), University of Tübingen (DE), RWTH Aachen University (DE)
Robert Bosch Stiftung, Bundesministerium für Gesundheit, RWTH Aachen University
Good health and well-being
Openalex Percentile: Top 6%
Drug-Induced Hepatotoxicity and Protection
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