Recombinant human growth hormone in pediatric patients using the FAERS database: Safety profile and update for the period 2004 - 2024.
This study highlights the importance of ongoing surveillance for safety signals associated with recombinant human growth hormone in pediatric patients.
Where it sits
this study against the rest of the hgh (somatropin) corpusSummary and findings
This study investigated safety signals associated with recombinant human growth hormone (rhGH) in pediatric patients using the FDA Adverse Event Reporting System (FAERS) from 2004 to 2024. A total of 33,888 adverse event reports were analyzed, identifying 167 positive signals across 19 System Organ Classes. The findings highlight the importance of ongoing surveillance for the safe clinical use of rhGH.
Abstract
Objective To investigate safety signals associated with recombinant human growth hormone (rhGH) using the FDA Adverse Event Reporting System (FAERS) and make recommendations for its application. Background rhGH is widely used in the management of pediatric growth disorders, but a comprehensive evaluation of its safety in pediatric populations is limited. Materials and methods Adverse event (AE) reports involving patients under 18 years of age where rhGH was the primary suspect (PS) drug were retrieved from the FAERS database for the period beginning the first quarter of 2004 to the end of the third quarter of 2024. The reports were standardized and duplicate reports removed. Disproportionality analysis of AE signals was conducted using four complementary methods, namely i) reporting odds ratio (ROR), ii) proportional reporting ratio (PRR), iii) Bayesian confidence propagation neural network (BCPNN), and iv) empirical Bayesian geometric mean (EBGM). Results A total of 33,888 AE reports were retrieved and analyzed. Disproportionality analysis identified 167 positive signals across 19 System Organ Classes (SOCs), the most frequently of which was "Investigations," and the most common preferred term (PT) was "Arthralgia". In addition to confirmed AEs, several endocrine-related signals were also recognized including a) fluctuations in thyroid-stimulating hormone, b) increase in unbound concentrations of thyroxine, c) type 1 diabetes mellitus, d) low concentrations of high-density lipoprotein, and e) abnormal body odor. Conclusion A comprehensive safety profile was established for rhGH when used in pediatric populations and comprising several newly identified potential AE signals. The findings underscore the importance of surveillance to mitigate risks and ensure the safe clinical use of rhGH.
Background
The study addresses the safety profile of recombinant human growth hormone (rhGH) in pediatric patients, a population where its use is common for growth disorders. Previous evaluations of rhGH safety have been limited, necessitating a comprehensive analysis of adverse events. This research is significant as it utilizes a large database to identify potential safety signals associated with rhGH.
Methods
The study conducted a retrospective analysis of adverse event reports from the FAERS database for patients under 18 years of age where rhGH was the primary suspect drug. The analysis covered reports from the first quarter of 2004 to the end of the third quarter of 2024. Disproportionality analysis was performed using four methods: reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and empirical Bayesian geometric mean.
Results
A total of 33,888 adverse event reports were retrieved and analyzed. The disproportionality analysis identified 167 positive signals across 19 System Organ Classes, with 'Investigations' being the most frequently reported. The most common preferred term was 'Arthralgia'. Endocrine-related signals included fluctuations in thyroid-stimulating hormone and type 1 diabetes mellitus.
Interpretation
The findings suggest that while rhGH is widely used, there are several newly identified potential adverse events that warrant attention. The effect sizes of the identified signals may not be clinically significant, and the reliance on FAERS data introduces potential confounding factors such as underreporting. These results underscore the importance of ongoing surveillance to ensure the safe use of rhGH in pediatric populations.
Key findings
- 33,888 AE reports retrieved and analyzed.
- 167 positive signals identified across 19 System Organ Classes.
- Most common preferred term was 'Arthralgia'.
- Endocrine-related signals included fluctuations in thyroid-stimulating hormone and type 1 diabetes mellitus.
Limitations
- Relies on FAERS data, which may be subject to underreporting.
- Observational nature limits causal inferences.
- Potential reporting bias in adverse event data.