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Actualización sobre el coronavirus (COVID-19): La FDA alerta a los consumidores sobre los kits de prueba para el COVID-19 fraudulentos no autorizados

Declaración del Dr. Stephen M. Hahn M.D., comisionado de la FDA y Judith A. McMeekin, Pharm.D., subcomisionada para Asuntos Regulatorios, Oficina de Asuntos Regulatorios

U.S. Food and Drug Administration (FDA) logo (PRNewsfoto/FDA)

News provided by

U.S. Food and Drug Administration

Mar 23, 2020, 17:21 ET

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SILVER SPRING, Maryland, 23 de marzo de 2020 /PRNewswire-HISPANIC PR WIRE/ -- La Administración de Alimentos y Medicamentos de los Estados Unidos está monitoreando de manera activa y agresiva el mercado para identificar cualquier empresa que esté comercializando con afirmaciones fraudulentas productos para el diagnóstico, prevención y tratamiento del coronavirus (COVID-19), como parte de nuestros esfuerzos continuos para proteger la salud pública durante esta pandemia. Como resultado de estas actividades, la agencia está comenzando a ver kits de prueba para el hogar fraudulentos y no autorizados que se están comercializando para detectar el COVID-19.

Queremos alertar al público estadounidense de que, en este momento, la FDA no ha autorizado ninguna prueba para el COVID-19 que esté disponible para su compra y para que usted se haga la prueba en su hogar. La FDA entiende el valor que tiene para la salud pública la expansión de la disponibilidad de las pruebas para el COVID-19, a través de pruebas seguras y precisas que tal vez incluyan la recolección de muestras en el hogar, y estamos trabajando activamente con los fabricantes de pruebas en este asunto.

Las afirmaciones de salud, pruebas y productos fraudulentos pueden presentar serios riesgos para la salud. Pueden prevenir que algunos pacientes busquen atención médica o retrasen tratamiento médico necesario. La FDA les recuerda a los consumidores que sigan las recomendaciones de los Centros para el Control y la Prevención de Enfermedades y que hablen con su proveedor médico si tienen síntomas del COVID-19. Su proveedor médico le aconsejará si debe hacerse la prueba y el proceso para hacérsela con la prueba adecuada.

La FDA tomará las medidas apropiadas para proteger a los consumidores de las personas que obran mal y que se aprovechan de una crisis para engañar al público mediante la comercialización de pruebas que presentan riesgos para la salud del paciente. Esto puede incluir la emisión de cartas de advertencia, incautaciones o acciones judiciales. Ya hemos identificado y emitido cartas de advertencia a las empresas que se estaban vendiendo y promoviendo artículos fraudulentos, y esperamos tomar acciones adicionales. Además, estamos intensificando el cumplimiento de la ley en los puertos de entrada, incluyendo las instalaciones de correo internacional, para garantizar que estos productos fraudulentos que se originan fuera del país no ingresen a través de nuestras fronteras.

Si tiene conocimiento de kits de prueba para el COVID-19 fraudulentos, repórtelo a la FDA. Continuaremos persiguiendo agresivamente a aquellos que ponen en riesgo la salud pública y responsabilizando aquellos que obren mal.

Como recordatorio, le recomendamos consultar las Directrices del Presidente sobre el Coronavirus para los Estados Unidos, las cuales detallan acciones simples que podemos tomar como individuos y familias para desacelerar al propagación del coronavirus.

La FDA, una dependencia del Departamento de Salud y Servicios Sociales de los Estados Unidos, protege la salud pública asegurando la protección, eficacia y seguridad de los medicamentos tanto veterinarios como para los seres humanos, las vacunas y otros productos biológicos destinados al uso en seres humanos, así como de los dispositivos médicos. La dependencia también es responsable de la protección y seguridad de nuestro suministro nacional de alimentos, los cosméticos, los suplementos dietéticos, los productos que emiten radiación electrónica, así como de la regulación de los productos de tabaco.

Información para los medios de comunicación:  Gloria Sánchez-Contreras, 301-796-7686, [email protected]; Información al consumidor: 888-INFO-FDA
www.FDA.gov/Espanol 

Foto - https://mma.prnewswire.com/media/317925/FDA_Logo.jpg

FUENTE U.S. Food and Drug Administration

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