PVLens: Enhancing Pharmacovigilance Through Automated Label Extraction
Journal:
arXiv
Published Date:
Mar 26, 2025
Abstract
Reliable drug safety reference databases are essential for pharmacovigilance,
yet existing resources like SIDER are outdated and static. We introduce PVLens,
an automated system that extracts labeled safety information from FDA
Structured Product Labels (SPLs) and maps terms to MedDRA. PVLens integrates
automation with expert oversight through a web-based review tool. In validation
against 97 drug labels, PVLens achieved an F1 score of 0.882, with high recall
(0.983) and moderate precision (0.799). By offering a scalable, more accurate
and continuously updated alternative to SIDER, PVLens enhances real-time
pharamcovigilance with improved accuracy and contemporaneous insights.
