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Evaluación de la seguridad de Omniscan: una vigilancia observacional posterior a la comercialización
Harsh Mahajan1, Nafisa S Batta1, Pravin Vaze2
1Radiology, Mahajan Imaging Pvt Ltd, Delhi, IND.
Cureus
|September 2, 2025
Resumen
La vigilancia posterior a la comercialización de Omniscan (gadodiamida) lo encontró seguro y bien tolerado. No se relacionaron eventos adversos con Omniscan durante el seguimiento inmediato o seis semanas después, lo que indica que no hubo un aumento de los riesgos de seguridad.
Área de la Ciencia:
- Radiología e Imágenes
- Farmacovigilancia de las sustancias
- Seguridad médica
Sus antecedentes:
- Omniscan (gadodiamida) es un agente de contraste basado en gadolinio utilizado en imágenes de resonancia magnética con contraste mejorado (IRM-CE).
- La vigilancia posterior a la comercialización es crucial para evaluar el perfil de seguridad de los agentes médicos en el mundo real.
Objetivo del estudio:
- Evaluar la seguridad y tolerabilidad de Omniscan (gadodiamida) en un entorno posterior a la comercialización.
- Monitorear los eventos adversos (EA) inmediatamente y seis semanas después de la administración de Omniscan.
Principales métodos:
- Se realizó un estudio abierto multicéntrico de un solo grupo en la India.
- Se incluyeron 150 participantes sometidos a una resonancia magnética con Omniscan.
- Se realizó un seguimiento telefónico seis semanas después de la inyección para recopilar datos de seguridad.
Principales resultados:
- 133 participantes completaron el seguimiento de seis semanas.
- Se informaron siete eventos adversos derivados del tratamiento (TEAE) (5, 26%).
- No se consideraron TEAE relacionados con Omniscan; uno fue grave (pusiendo en peligro la vida) y otro fue grave.
Conclusiones:
- Omniscan (gadodiamida) demostró un perfil de seguridad favorable sin eventos adversos causalmente relacionados.
- El estudio no confirmó ningún aumento de los riesgos de seguridad asociados con el uso de Omniscan.
- Omniscan fue generalmente seguro y bien tolerado en los procedimientos de IRM-CE.
Palabras clave:
acontecimiento adversoImágenes por resonancia magnéticaAgente de contraste a base de gadoliniovigilancia de la droga después de su comercializaciónestudio de seguridadMás Videos Relacionados
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