Pediatric Off-label Antipsychotic Use for Attention-Deficit/Hyperactivity Disorder.

PURPOSE

Off-label antipsychotic use for behavioral symptoms in pediatric attention-deficit/hyperactivity disorder (ADHD) poses safety concerns, and evidence to support such use is limited. This study aims to investigate the risk of off-label antipsychotic use associated with comorbid disruptive behavior disorder (DBD) among a cohort of youth with ADHD.

METHODS

A cohort study was conducted using IQVIA PharMetrics Plus for Academics data from 2007 to 2020. Youth 5 to 15 years of age at the index ADHD visit were included in the cohort. The index ADHD visit meets at least 1 of the following criteria: (1) 1 inpatient ADHD visit, (2) 2 outpatient ADHD visits within 90 days, or (3) an ADHD medication prescription fill within 30 days of an outpatient ADHD visit. We excluded youth who had a diagnosis of DBD or a US Food and Drug Administration (FDA)-approved indication for antipsychotics at baseline. Youth were followed up until antipsychotic initiation or were censored at a loss of coverage, receipt of an FDA-indicated diagnosis, or end of the study. A Cox proportional hazards regression model with DBD as a time-varying covariate estimated the hazard of antipsychotic use after the index ADHD visit.

FINDINGS

Of 41,098 youth with ADHD who met the study criteria, 4557 were diagnosed with DBD during follow-up. The incidence of antipsychotic initiation was 19.6 (95% CI, 18.7- 20.5) per 1000 person-years. After adjustment for baseline covariates, the hazard ratio of antipsychotic initiation associated with DBD was 4.64 (95% CI, 4.15-5.18).

IMPLICATIONS

Antipsychotic use among youth with ADHD is more likely in the presence of DBD, suggesting that an off-label use is for behavior problems.