Signal mining and analysis of adverse events in children using growth hormones: A retrospective real-world study based on FAERS.
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This study aims to analyze the adverse events (AEs) related to the use of growth hormone (GH) drugs in children through mining the FDA adverse event reporting system (FAERS) database, and provide references for clinical medication safety. Data on children under 18 years of age from the FAERS database, covering the first quarter of 2004 to the first quarter of 2024, were extracted via the OpenVigil 2.1 tool. The reporting odds ratio was employed to analyze AE signals related to GHs. A total of 10,559 AE reports for children using GHs were obtained, revealing 361 risk signals across 20 organ systems. The top 5 system organ categories on the basis of the number of reports were general disorders and administration site conditions (33.4%), investigations (19.97%), musculoskeletal and connective tissue disorders (13.47%), nervous system disorders (13.06%), and metabolism and nutrition disorders (3.55%). Among the positive signals not mentioned in the product labeling, the top 5 were elevated blood urea nitrogen/creatinine ratio, increased bone density, decreased vitamin D, sleep apnea syndrome, and papilloedema. The findings align with known AEs (e.g., injection site reactions, headaches) but also reveal unreported risks, emphasizing gaps in current labeling. High signal intensity for musculoskeletal and neurological events underscores the need for targeted monitoring. While tumor-related reports (3.28%) were noted, existing databases suggest no causal link, highlighting the limitations of FAERS in establishing causality. Racial bias in reporting (predominantly from the US) and voluntary reporting biases may affect generalizability. The signal intensity associated with muscle, skeletal, and neurological abnormalities in children via GHs is relatively high. Continuous monitoring and enhanced medication oversight are necessary.