World Journal of
Pharmaceutical and Life Sciences

PHARMACEUTICAL TOXICOLOGY: EVALUATING THE IMPACT OF DRUGINDUCED LIVER INJURY (DILI) IN CLINICAL PRACTICE AND DRUG DEVELOPMENT

Weddah O. Abdulrahman*, Lana Salman Alanazi, Hameeda Aljanabi, Yasmin Alhazime, Dania Raffa, Abdulaziz Almutairi

ABSTRACT

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.

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