| アブストラクト | BACKGROUND: Pediatric attention-deficit/hyperactivity disorder (ADHD) medications have been analyzed in the FDA Adverse Event Reporting System (FAERS), yet systematic age-stratified signal profiling under ICH E11(R1) developmental categories, covering the recently approved agents viloxazine and serdexmethylphenidate, remains unreported. METHODS: We performed a retrospective disproportionality analysis of pediatric (age <18 years) FAERS reports, 2014Q1-2024Q4, after FDA-standard three-step deduplication. Ten active ingredients (eight in the main analysis, two in a new-drug branch) were identified. Reporting odds ratios (ROR), proportional reporting ratios (PRR), information components (IC, Bate 1998 uniform prior), and empirical Bayesian geometric means (EBGM, DuMouchel 1999) were computed. A signal was classified as Strong when positive across all four methods. Seven prespecified sensitivity analyses were conducted. RESULTS: Among 15,301 pediatric ADHD cases, 100 Strong signals were identified (71 in adolescents, 29 in children). alpha2-agonists accounted for 79/100 (clonidine-ER 52, guanfacine-ER 27). A novel dextroamphetamine-posterior reversible encephalopathy syndrome (PRES) signal was reproducible across three independent sensitivity analyses. Methylphenidate showed no Strong signals under within-class or full-pediatric comparators. CONCLUSION: Distinct age-specific safety signals emerged for ADHD medications, with dextroamphetamine-PRES warranting targeted pharmacovigilance attention. |
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