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Invima ordena el retiro del mercado de medicamentos orales que contienen Ranitidina

El Instituto Nacional de Vigilancia de Medicamentos y Alimentos (Invima), emitió la Alerta Sanitaria N°110-2020, por medio de la cual ordena el retiro preventivo del mercado de todos los lotes medicamentos orales que contienen Ranitidina, en atención a las investigaciones y alertas sanitarias publicadas a nivel mundial sobre la presencia de la impureza N-nitrosodimetilamina (NDMA).

De igual manera se ordenó la suspensión, distribución y venta de nuevos lotes de medicamentos por vía oral que contengan Ranitidina, hasta que los titulares de los registros sanitarios lleven a cabo los análisis de riesgo y realicen las pruebas de control de calidad en el producto terminado para determinar que estos medicamentos son seguros.

Inicialmente, estas medidas no aplicarán para los productos inyectables que contengan Ranitidina al ser esenciales en algunas indicaciones terapéuticas. Sin embargo, el Instituto hace un llamado a las sociedades médicas para considerar de inmediato la implementación de alternativas terapéuticas y ajustar las guías de manejo.

A partir del 9 de julio de 2020, se otorgará el plazo de (1) mes para que los hospitales, clínicas e IPS tomen las medidas correctivas, posteriormente, se iniciará el retiro preventivo del mercado de todos los lotes de productos inyectables que contengan Ranitidina.

Las personas que se encuentren consumiendo medicamentos orales que contengan Ranitidina, deberán acudir a su médico tratante para solicitar una alternativa terapéutica.

El Invima, en su facultad de autoridad sanitaria, continuará protegiendo y promoviendo la salud pública del país y caso de identificar cualquier anomalía con alguno de los productos objeto de vigilancia, informará de manera oportuna a la ciudadanía.

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