| アブストラクト | BACKGROUND: Pediatric drug-induced hyperglycemia/diabetes mellitus (DIH/DIDM) is regarded as a preventable iatrogenic condition; nevertheless, its clinical under-recognition persists, and age-specific pharmacovigilance evidence remains critically deficient. This study conducted a retrospective pharmacovigilance investigation to identify risk signals associated with pediatric DIH/DIDM. RESEARCH DESIGN AND METHODS: We extracted pediatric (age < 18 years) adverse-event reports from the FDA Adverse Event Reporting System (2004 Q1-2025 Q1) and retained those mapped to any of nine predefined MedDRA Preferred Terms (PTs) for hyperglycemia or diabetes mellitus. A disproportionality analysis was subsequently performed to estimate the reporting association between suspect drugs and the events of interest. RESULTS: We mined 504,458 pediatric adverse-event reports from the U.S. FDA Adverse Event Reporting System (2004Q1-2025Q1) and detected 195 positive drug-adverse event signals. Among 2,436 pediatric DIH/DIDM cases, 72% were adolescents aged 10-18 years; the overall median age was 13 years (IQR 9-16). Antineoplastic agents, glucocorticoids, immunosuppressants, psychotropic medications, and growth hormone constituted five cardinal risk clusters, and Off-label signals for drugs-including minocycline and montelukast-were captured for the first time. Underlying conditions were predominantly acute lymphoblastic leukemia, neuropsychiatric disorders, immunosuppression-related disorders, and growth hormone deficiency. CONCLUSION: Our study systematically delineated the risk signals implicated in pediatric DIH/DIDM. Clinicians should heighten surveillance when prescribing potentially diabetogenic agents and pay particular attention to age-related windows of susceptibility. |
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