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

An analysis of the FDA Adverse Event Reporting System from 2004 to 2023 identified 21 drugs potentially linked to increased suicidal ideation risk in children aged 6–17. Among 4,779 valid cases, montelukast was the most commonly reported drug, and esketamine showed the highest statistical signal. The most common indications were ADHD, depression, acne, and asthma. Cumulative incidence of suicidal ideation within 90 days was 51.6% in males and 58.8% in females; within 360 days it was 76.9% and 85.3%, respectively. The findings suggest specific medications may pose elevated risk, but further research is needed to confirm.

Study at a glance

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.