To systematically identify drugs associated with pediatric aggression using the FDA Adverse Event Reporting System (FAERS) and examine age/sex-specific differences and time-to-onset patterns.
Key Findings:
31 drugs exhibited positive signals for aggression, primarily from nervous system (45.16%) and respiratory (32.26%) agents.
Strongest signals were for ebastine (ROR: 23.40) and perampanel (17.41); montelukast had the highest case volume (N = 1,392).
Higher risks of aggression were observed in younger children and females, with median time-to-onset ranging from 2-3 days for anti-infectives to 133 days for montelukast.
Interpretation:
Remove this section as it contains unsupported conclusions.
Limitations:
The study relies on spontaneous reporting data, which may be subject to underreporting and reporting biases.
The analysis does not establish causation, only associations between medications and aggression.
Conclusion:
Revise to eliminate unsupported claims and focus on summarizing findings without editorializing.
