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Comparative Analysis of Human Growth Hormone in Serum Using SPRi, Nano-SPRi and ELISA Assays
Published on: January 7, 2016
Signal mining and analysis of adverse events in children using growth hormones: A retrospective real-world study
1Department of Pharmacy, The Fourth Affiliated Hospital of Soochow University, Suzhou Dushu Lake Hospital, Medical Center of Soochow University, Jiangsu Suzhou, China.
Insights
Growth hormone (GH) drug use in children is linked to potential adverse events (AEs), including musculoskeletal and neurological issues. Analysis of FDA data reveals risks beyond current product labeling, necessitating enhanced medication safety monitoring.
Area of Science:
- Pharmacovigilance
- Pediatric Endocrinology
- Drug Safety
Background:
- Growth hormone (GH) therapy is used for various pediatric conditions.
- Understanding adverse events (AEs) associated with GH use is crucial for patient safety.
- The FDA Adverse Event Reporting System (FAERS) is a valuable resource for post-marketing surveillance.
Purpose of the Study:
- To analyze AEs of GH drugs in children using the FAERS database.
- To identify potential safety signals not currently listed in product labeling.
- To provide evidence for improved clinical medication safety guidelines.
Main Methods:
- Data mining of the FAERS database (Q1 2004 - Q1 2024) for pediatric GH users.
- Utilized OpenVigil 2.1 for data extraction.
- Employed the reporting odds ratio (ROR) to detect AE signals.
Main Results:
- 10,559 AE reports identified, yielding 361 risk signals across 20 organ systems.
- Most frequent AEs involved general disorders, investigations, musculoskeletal, and nervous system issues.
- Unlabeled safety signals included elevated BUN/creatinine, increased bone density, decreased vitamin D, sleep apnea, and papilledema.
Conclusions:
- GH use in children presents known AEs and previously unreported risks, particularly musculoskeletal and neurological.
- Current product labeling may not fully encompass all potential AEs.
- Continuous pharmacovigilance and enhanced medication oversight are recommended for pediatric GH therapy.
Abstract:
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.
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