A real-world investigation of drug-induced hyperglycemia and diabetes mellitus in pediatric populations using the FDA adverse event reporting system
Year: 2026
Type: article
Study design: Observational Study
Abstract: 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.
Source: Frontiers in Medicine
Authors: Xue Zhao, Xiutian Sun, Meng Ma, Lijuan Teng, Xiaohua Qu
Institution: Weifang People's Hospital
Language: English
Subfield: Toxicology
Domain: Life Sciences
Open Access status: gold
Estimated APC paid: $3,801
OpenAlex ID: W7125982441