- PUBLICADO:
¿Por qué el invima ordenó retirar del mercado la Ranitidina?
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Mediante una alerta sanitaria el Instituto Nacional de Vigilancia de Medicamentos y Alimentos (Invima) ordenó de manera preventiva el retiro de todos los lotes de los medicamentos con principio activo Ranitidina Solución inyectable, esto debido al posible riesgo de presencia de niveles de Nitrosamina nitrosodimetilamina (NDMA) en el producto.
También puede leer: hospital San Andrés de Tumaco avanza en su recuperación
La Nitrosamina según la Agencia Internacional de Investigación del Cáncer (IARC), está clasificada como “probablemente carcinogénica” (Categoría 2) y puede encontrarse también en el humo del tabaco, algunos alimentos procesados y en ciertos artículos de aseo, etc.
De acuerdo con lo anterior, el ente de control sanitario ha hecho el siguiente llamado a la comunidad en general. “Si ha presentado algún evento adverso, asociado al consumo de este producto, repórtelo en Bogotá, de manera inmediata a través del sitio web del Invima en “Medicamentos y productos biológicos” – “Reporte de eventos adversos para pacientes”.
Medidas para secretarías de salud departamentales, distritales y municipales
Asimismo, el Invima indicó a las secretarías de salud departamentales, distritales y municipales a que realicen actividades de inspección, vigilancia y control en los establecimientos de su competencia, esto con el fin de mitigar la comercialización de la Ranitidina solución inyectable.
Además, estas deberán informar al ente de control sanitario en caso de hallar en los canales comerciales el producto. De igual forma, deben difundir la alerta a las Entidades Administradoras de Planes de Beneficio – EAPB, Instituciones Prestadoras de Servicios de Salud – IPS y demás actores del sector salud de su competencia.
Medidas para la Red Nacional de Farmacovigilancia
Finalmente, el Invima solicita que desde los programas institucionales de Farmacovigilancia se realice la búsqueda activa que garantice la detección de reacciones adversas donde se involucren medicamentos que contengan como principio activo Ranitidina en solución inyectable y sean reportados al Programa Nacional de Farmacovigilancia de Invima los eventos adversos asociados a la presente alerta.
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