Drug-related suicidal ideation in the K-12 population: a real-world pharmacovigilance study of the FDA adverse event reporting system (FAERS) database.
Journal of psychiatric research – August 01, 2025
Source: PubMed
Summary
Real-world data reveals concerning links between certain medications and suicidal thoughts in school-aged children. Analysis of 4,779 adverse event reports from FAERS shows that teenagers 15-17 were most affected, with more cases in males than females. The asthma drug montelukast topped the list of 21 medications associated with suicidal ideation in the K-12 population.
Abstract
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. 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. 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. 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.