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Análisis de desproporcionalidad de los eventos adversos asociados con fondaparinux basado en el sistema de
Fengjiao Kang1,2, Yin Wang1, Fengqun Cai1
1Department of Pharmacy, Personalized Drug Research and Therapy Key Laboratory of Sichuan Province, Sichuan Provincial People's Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.
PloS one
|February 11, 2026
Resumen
El fondaparinux, un anticoagulante, plantea riesgos de sangrado. Este estudio analizó los datos de la FDA, identificando eventos adversos específicos y grupos de pacientes que requieren un monitoreo intensivo para un uso clínico más seguro.
Área de la Ciencia:
- Farmacología Farmacología.
- Seguridad clínica y seguridad clínica.
- Informática de la salud Informática de la salud.
Sus antecedentes:
- Fondaparinux es un anticoagulante crítico que inhibe el factor Xa para el tromboembolismo venoso y el síndrome coronario agudo.
- A pesar de su eficacia, fondaparinux se asocia con un riesgo significativo de eventos de sangrado.
- Comprender su perfil de seguridad es crucial para optimizar la atención al paciente y guiar la investigación futura.
Objetivo del estudio:
- Para analizar exhaustivamente el perfil de seguridad de fondaparinux.
- Para identificar eventos adversos específicos y datos demográficos de pacientes asociados con el uso de fondaparinux.
- Proporcionar recomendaciones basadas en la evidencia para mejorar la aplicación clínica segura de fondaparinux.
Principales métodos:
- Utilizó la base de datos del Sistema de Notificación de Eventos Adversos (FAERS) de la FDA desde el primer trimestre de 2004 hasta el tercer trimestre de 2024.
- Empleó métodos de farmacovigilancia que incluyen la relación de probabilidades de reporte (ROR), la relación de reporte proporcional (PRR), la red neuronal de propagación de confianza bayesiana (BCPNN) y la media geométrica bayesiana empírica (EBGM).
- Analizó más de 21 millones de informes, centrándose en 5.788 relacionados con fondaparinux y sus 17.523 eventos adversos asociados.
Principales resultados:
- Los sistemas vascular y sanguíneo/linfático fueron los más afectados por los eventos adversos relacionados con fondaparinux.
- Las fuertes señales de seguridad incluyeron una concentración anormal del factor de coagulación X, trombosis con síndrome de trombocitopenia y hematoma en el sitio de la incisión.
- Las reacciones adversas fueron más frecuentes en mujeres y pacientes de edad avanzada, particularmente en el primer mes de tratamiento.
Conclusiones:
- El análisis de seguridad de Fondaparinux reveló riesgos específicos, incluida la trombocitopenia inducida por heparina y la eosinophilia.
- Los pacientes ancianos y las mujeres requieren una atención especial debido al aumento de la frecuencia de eventos adversos.
- Se recomienda una mayor farmacovigilancia y estrategias de mitigación de riesgos para una administración más segura de fondaparinux.
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