Signal Mining and Analysis of Adverse Events in Children Using Growth Hormones: A Real-World Study Based on FAERS

Objective: This study aims to analyze the adverse event (ADE)related to the use of growth hormone drugs in children through mining the FDA Adverse Event Reporting System (FAERS) database, and provide references for clinical medication safety. Methods: Data on children under 18 years of agefrom 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 (ROR) was employed to analyze adverse event signals related to growth hormones. Results: A total of 10,487 ADE reports for children using growth hormones were obtained, revealing 381 risk signals across 20 organ systems. The top five system organ categories on the basis of the number of reports were general disorders and administration site conditions (29.82%), investigations (20.11%), musculoskeletal and connective tissue disorders (13.51%), nervous system disorders (13.15%), and neoplasms benign, malignant and unspecified (6.47%). Among the positive signals not mentioned in the product labeling, the top five included non-high-density lipoprotein cholesterol increased, blood 25-hydroxycholecalciferol decreased, blood urea nitrogen/creatinine ratio increased, globulins decreased, elbow deformity. Conclusion: The signal intensity associated with muscle, skeletal, and neurological abnormalities, as well as tumor occurrence in children via growth hormones, is relatively high. Continuous monitoring and enhanced medication oversight are necessary.