Liver injury in children: signal analysis of suspected drugs based on the food and drug administration adverse event reporting system.

ABSTRACT:

Background

Evidence of drug-induced liver injury is abundant in adults but is lacking in children. Our aim was to identify suspected drug signals associated with pediatric liver injury.

Methods

Hepatic adverse events (HAEs) among children reported in the Food and Drug Administration Adverse Event Reporting System were analyzed. A descriptive analysis was performed to summarize pediatric HAEs, and a disproportionality analysis was conducted by evaluating reporting odds ratios (RORs) and proportional reporting ratios to detect suspected drugs.

Results

Here, 14,143 pediatric cases were reported, specifically 49.6% in males, 45.1% in females, and 5.2% unknown. Most patients (68.8%) were 6-18 years old. Hospitalization ranked first among definite outcomes (7,207 cases, 37.

SUBMITTER: Liu Y 

PROVIDER: S-EPMC10537493 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature