Exploring the potential association between stimulant or atomoxetine use and suicidal or self-injurious behaviors in children with attention deficit hyperactivity disorder: real-world insights from the FAERS database

This study aims to investigate the potential correlation between commonly prescribed attention-deficit/hyperactivity disorder (ADHD) medications and suicidal or self-injurious behaviors (SSIBs) among the pediatric population by exploring the FDA Adverse Event Reporting System (FAERS) database. The FAERS database (2004Q1–2023Q4) was queried and SSIBs cases associated with stimulants (methylphenidate, and amphetamine) or atomoxetine were identified. The signals for SSIBs were analyzed using disproportionate methods, and the accuracy of the results was validated through sensitivity analysis with multifactor logistic regression. Time-to-onset analysis explored factors affecting SSIBs manifestation. Disproportionality analysis revealed a significant negative association between methylphenidate and SSIBs, while atomoxetine exhibited a significant positive correlation with SSIBs. The frequency of SSIBs was lower with stimulants alone or with the combined use of stimulants and atomoxetine compared to atomoxetine alone. Time-to-onset analysis indicated that all cases were of the early failure type, with the median time to onset of SSIBs associated with atomoxetine occurring later than that linked to stimulants. Stratification by age showed that in the stimulant group, the median time to SSIBs was longer for patients aged 13–17 years compared to those aged 6–12 years. Conversely, the opposite trend was observed in the atomoxetine group. The observed differences in time to onset highlight the importance of individualized screening for SSIBs across various populations, ultimately improving patient outcomes in the follow-up of stimulants or atomoxetine recipients.