Comprehensive Pharmacovigilance Assessment of Pegvisomant-Associated Adverse Events Using the FDA Adverse Event Reporting System and World Health Organization VigiAccess Databases
Authors' conclusion
This analysis identified reproducible reporting patterns for pegvisomant across 2 pharmacovigilance databases. Endocrine and laboratory-related terms were mainly interpreted as monitoring-related findings, whereas clinically relevant suspected adverse reaction signals were more evident for hepatobiliary events, injection-site reactions, and product administration-related problems.
Study context
- Population
- Reports of adverse events (AEs) associated with pegvisomant in the U.S. FDA Adverse Event Reporting System (FAERS) and WHO VigiAccess3,272 FAERS, 3413 VigiAccess reports
Methodological detailsdisproportionality analysis, FAERS and WHO VigiAccess databases, exploratory signal screening, time-to-onset analysis
- Disproportionality analysis
- FAERS and WHO VigiAccess databases
- Exploratory signal screening
- Time-to-onset analysis
Primary result
As reported in the abstract
Pegvisomant-associated AE reporting signals
- Most frequent AEs: general disorders, administration-site conditions and injury-related complications
- Significant disproportionality in endocrine-related categories; many preferred term-level signals reflected pharmacodynamic or monitoring effects
- Clinically relevant suspected AEs in hepatobiliary disorders, injection-site reactions, hypersensitivity and administration-related issues
- Exploratory signal-screening, not causal comparative analysis
Further findings
| Outcome | Values |
|---|---|
| Time to onset (FAERS) | FAERS median 164 (IQR 1–1052) days |
Time to onset (FAERS)
- Considerable variability, both early and delayed events
Original publication
Comprehensive Pharmacovigilance Assessment of Pegvisomant-Associated Adverse Events Using the FDA Adverse Event Reporting System and World Health Organization VigiAccess Databases. Endocr Pract. Published 31 March 2026. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →