An investigation of broad-spectrum antibiotic-induced liver injury based on the FDA Adverse Event Reporting System and retrospective observational study

• Published in: Scientific reports Vol. 14; no. 1; pp. 18221 - 13
• Main Authors: Shiraishi, Chihiro, Kato, Hideo, Ogura, Toru, Iwamoto, Takuya
• Format: Journal Article
• Language: English
• Published: London Nature Publishing Group UK 06.08.2024; Nature Publishing Group; Nature Portfolio
• Subjects: 692/308; 692/499; Adult; Adverse Drug Reaction Reporting Systems; Adverse events; Aged; Alanine transaminase; Anti-Bacterial Agents - adverse effects; Antibiotics; Bacterial diseases; Carbapenems; Chemical and Drug Induced Liver Injury - epidemiology; Chemical and Drug Induced Liver Injury - etiology; Female; Humanities and Social Sciences; Humans; Intensive care; Intensive Care Units; Liver; Male; Meropenem; Meropenem - adverse effects; Meropenem - therapeutic use; Middle Aged; multidisciplinary; Observational studies; Piperacillin; Piperacillin, Tazobactam Drug Combination - adverse effects; Retrospective Studies; Risk Factors; Science; Science (multidisciplinary); Sepsis; Tazobactam; United States - epidemiology; United States Food and Drug Administration; β Lactamase; β-Lactam antibiotics; United States
• ISSN: 2045-2322; 2045-2322
• DOI: 10.1038/s41598-024-69279-6

Tazobactam/piperacillin and meropenem are commonly used as an empiric treatment in patients with severe bacterial infections. However, few studies have investigated the cause of tazobactam/piperacillin- or meropenem-induced liver injury in them. Our objective was to evaluate the association between tazobactam/piperacillin or meropenem and liver injury in the intensive care unit patients. We evaluated the expression profiles of antibiotics-induced liver injury using the US Food and Drug Administration Adverse Event Reporting System (FAERS) database. Further, in the retrospective observational study, data of patients who initiated tazobactam/piperacillin or meropenem in the intensive care unit were extracted. In FAERS database, male, age, the fourth-generation cephalosporin, carbapenem, β -lactam and β -lactamase inhibitor combination, and complication of sepsis were associated with liver injury ( p  < 0.001). In the retrospective observational study, multivariate logistic regression analyses indicated that the risk factors for liver injury included male ( p  = 0.046), administration period ≥ 7 days ( p  < 0.001), and alanine aminotransferase ( p  = 0.031). Not only administration period but also sex and alanine aminotransferase should be considered when clinicians conduct the monitoring of liver function in the patients receiving tazobactam/piperacillin or meropenem.