# A real-world investigation of drug-induced hyperglycemia and diabetes mellitus in pediatric populations using the FDA adverse event reporting system

## TL;DR

This study identifies drugs linked to high blood sugar and diabetes in children using FDA reports, highlighting key risk groups and age patterns.

## Contribution

The study provides the first systematic pharmacovigilance analysis of drug-induced hyperglycemia/diabetes in pediatric populations using FDA data.

## Key findings

- 195 drug–adverse event signals were detected in 504,458 pediatric reports, with 72% of cases in adolescents aged 10–18 years.
- Key drug risk clusters include antineoplastic agents, glucocorticoids, and psychotropic medications, with new signals for minocycline and montelukast.
- Common underlying conditions include leukemia, neuropsychiatric disorders, and growth hormone deficiency in affected children.

## Abstract

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.

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.

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.

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.