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El creciente mal uso de los sistemas de notificación de farmacovigilancia: una amenaza para la medicina basada en la
Charles Khouri1,2, Alex Hlavaty1,2, Michele Fusaroli3
1Univ. Grenoble Alpes, Pharmacovigilance Unit, Grenoble Alpes University Hospital, Grenoble, France.
Clinical pharmacology and therapeutics
|December 21, 2025
Resumen
Las bases de datos públicas de eventos adversos, como la de la FDA
Área de la Ciencia:
- Farmacovigilancia y Ciencia Regulatoria
- Bioestadística y Ciencia de Datos
Sus antecedentes:
- Las agencias reguladoras brindan acceso público a las bases de datos de notificación de eventos adversos (por ejemplo, FAERS de la FDA).
- Los paneles fáciles de usar facilitan el acceso a los datos, lo que aumenta la utilización de la base de datos.
- Esta accesibilidad ha provocado, lamentablemente, un aumento de la investigación de baja calidad.
Objetivo del estudio:
- Destacar los desafíos y las posibles interpretaciones erróneas derivadas de la disponibilidad pública de las bases de datos de notificación de eventos adversos.
- Advertir contra la presentación no científica de asociaciones estadísticas como señales de seguridad definitivas.
Principales métodos:
- Análisis de las tendencias en las publicaciones de investigación que utilizan bases de datos públicas de eventos adversos.
- Revisión de las metodologías empleadas en los estudios que informan sobre datos de eventos adversos.
- Evaluación de la interpretación y comunicación de los hallazgos de dichas bases de datos.
Principales resultados:
- Se ha observado un aumento significativo en la investigación que utiliza bases de datos públicas de eventos adversos.
- Muchos estudios informan numerosas asociaciones estadísticas erróneamente etiquetadas como 'señales de seguridad'.
- Esto puede generar alarma científicamente infundada entre los proveedores de atención médica y los pacientes.
Conclusiones:
- La disponibilidad pública de las bases de datos de eventos adversos requiere una evaluación crítica de las metodologías de investigación.
- La mala interpretación de las asociaciones estadísticas puede afectar negativamente las prácticas de atención médica y el comportamiento del paciente.
- La promoción del análisis riguroso de datos y la presentación de informes responsable es crucial para una farmacovigilancia precisa.
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