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PVLens: Mejora de la Farmacovigilancia Mediante la Extracción Automatizada de Etiquetas

Jeffery L Painter¹, Gregory E Powell¹, Andrew Bate^2,3

¹GSK, Durham, NC, USA.

AMIA ... Annual Symposium proceedings. AMIA Symposium

|February 23, 2026

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Reliable drug safety reference databases are essential for pharmacovigilance, yet existing resources like SIDER are outdated and static.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.

Palabras clave:

Farmacovigilancia Extracción de datos Etiquetas de medicamentos FDA MedDRA Procesamiento del lenguaje natural Seguridad de los medicamentos

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