Drug Induced Liver Injury in Children: A Nationwide Cohort Study from China

Background & Aims Currently, there is limited knowledge on the clinical profile of drug induced liver injury (DILI) in Chinese children. We aimed to assess the clinical characteristics, suspected drugs, and outcomes associated with pediatric DILI in China. Methods This nationwide, multi-center, retrospective study, conducted between 2012 and 2014, analyzed 25,927 cases of suspected DILI at 308 medical centers using the inpatient medical register system. Utilizing the Roussel Uclaf Causality Assessment Method (RUCAM) score, only patients with scores>6 or diagnosed with DILI by at least two experts after scoring <6 were included in the analysis. Among them, 460 cases met the European Association for the Study of Liver (EASL) biochemical criteria. The study categorized children into three age groups: toddlers (≥30 days to <6 years old), school-age children (6 to <12 years old), and adolescents (12 to <18 years old). Results Hepatocellular injury was the predominant clinical classification, accounting for 63% of cases, with 34% of these cases meeting Hy's law criteria. Adolescents comprised the majority of children with moderate/severe DILI (65%). Similarly, adolescents faced a significantly higher risk of severe liver injury compared to younger children (adjusted odd ratio [aOR]=4.75, p =.002). The top three most frequently prescribed drug classes across all age groups were antineoplastic agents (25.9%), antimicrobials (21.5%), and traditional Chinese medicine (TCM, 13.7%). For adolescents, the most commonly suspected drugs were antituberculosis drugs (22%) and TCM (23%). Conclusion Adolescents are at a greater risk of severe and potentially fatal liver injury compared to younger children. Recognizing the risk of pediatric DILI is crucial for ensuring safe medical practices.