Drug-related suicidal ideation in the K-12 population: a real-world pharmacovigilance study of the FDA adverse event reporting system (FAERS) database

Abstract

Objective

The K-12 population refers to individuals, primarily aged 6–17, from kindergarten through 12th grade. Drug-related suicidal ideation (SI) in the K-12 population is a major concern. This study aims to identify medications linked to increased SI risk in the K-12 population using the FDA Adverse Event Reporting System (FAERS) database.

Methods

We extracted cases of SI in individuals aged 6–17 years where medications were the primary suspect (PS) from the FAERS database, spanning from the first quarter of 2004 to the third quarter of 2023. We conducted descriptive analysis, disproportionality analysis, and subgroup analysis.

Results

Our analysis included 4,779 valid cases; 52.75 % were male and 45.66 % were female. The predominant age group was 15–17 years, accounting for 43.92 % of cases. The peak year for case reports was 2019. Montelukast was the most common drug. The four most common indications included attention deficit hyperactivity disorder, depression, acne, and asthma. Disproportionality analysis highlighted 21 drugs as potentially associated with increased SI risk, with esketamine displaying the highest signal (Reporting Odds Ratio, ROR = 103.49). Subgroup analysis identified eleven drugs with elevated risk signals in both genders. Montelukast presented the highest signal in males (ROR = 12.64), and esketamine in females (ROR = 129.50). Cumulatively, the incidence of SI within 90 and 360 days was 51.6 % and 76.9 % in males, and 58.8 % and 85.3 % in females, respectively.

Conclusion

This study provides evidence of potential SI risk associated with specific medications in the K-12 population. Further research is necessary to confirm these findings.