Background: Drug-induced liver injury (DILI) represents a significant clinical and public health challenge, accounting for approximately 11-15% of cases in tertiary care centers and serving as the leading cause of acute liver failure in Western countries. This study provides a comprehensive evaluation of DILI epidemiology, clinical characteristics, diagnostic patterns, and outcomes to inform both clinical practice and pharmaceutical drug development. Methods: A retrospective cohort analysis was conducted on 350 DILI cases. Demographic data, implicated drug categories, laboratory parameters (ALT, total bilirubin, INR), RUCAM causality scores, and clinical outcomes were analyzed. Chi-square tests, independent t-tests, ANOVA, correlation analysis, receiver operating characteristic (ROC) curves, and multivariate logistic regression were employed for statistical evaluation. Results: The cohort comprised 350 patients (61.7% female) with mean age 51.5 +/- 16.6 years. Antibiotics were the most common causative agents (33.1%), followed by antituberculosis drugs (10.6%) and herbal/supplements (8.6%). Hepatocellular injury predominated (52.3%). Hy's law was observed in 21.1% of cases, while chronic DILI occurred in 11.7%. Overall mortality was 11.1%, with ALF/transplantation in 5.4%. Multivariate analysis identified hepatocellular pattern as an independent predictor of severe outcome (OR 2.38, 95% CI: 1.01-5.59, p = 0.047). Severity classification was significantly associated with clinical outcomes (chi-square = 26.93, p < 0.001). Conclusions: DILI remains a critical challenge in both clinical medicine and pharmaceutical development. Early recognition, systematic causality assessment, and risk stratification based on clinical patterns and laboratory parameters are essential for improving patient outcomes. These findings underscore the need for enhanced pharmacovigilance systems and integration of biomarkers in drug development protocols.
Weddah O. Abdulrahman*, Lana Salman Alanazi, Hameeda Aljanabi, Yasmin Alhazime, Dania Raffa, Abdulaziz Almutairi (Fri,) studied this question.