WASHINGTON.- La gubernamental Administración de Alimentos y Fármacos (FDA, en inglés) revocó este lunes su autorización para uso de urgencia del medicamento para la malaria empleado en el tratamiento de la COVID-19, la hidroxicloroquina, y del compuesto relacionado cloroquina.

En una carta, la científica jefa de la FDA, Denise Hinton, dirigida al vicesecretario adjunto de la Autoridad para la Investigación Biomédica Avanzada y Desarrollo (BARDA, en inglés), Gary Disbrow, señala que, con base a datos, como resultados de análisis clínicos, han concluido que es probable que el fármaco “no sea efectivo” frente a la COVID-19.

Además, apuntó que los datos recientes no arrojan ninguna prueba de que sean beneficiosos para disminuir la mortalidad entre los pacientes de coronavirus o que ofrezcan alguna otra ventaja, como la reducción de la estancia en el hospital.

La FDA emitió una autorización para uso de urgencia de la cloroquina y de la hidroxicloroquina en marzo para pacientes que estuvieran hospitalizados por la COVID-19 y aquellos que participaran en ensayos clínicos.

En abril, el regulador advirtió de que no se prescribieran esos fármacos fuera de los centros médicos.

Debido a que la hidroxicloroquina sí que está aprobada en EE.UU. para tratar enfermedades como el lupus o la artritis, los médicos todavía podrán administrarla a los pacientes de coronavirus, siempre y cuando no la receten expresamente para la COVID-19.

El presidente de EE.UU., Donald Trump, ha sido uno de los mayores promotores de la hidroxicloroquina para tratar el coronavirus, lo que ha generado tensiones en su Gobierno. E incluso llegó a revelar que la tomaba diario de manera preventiva, aunque aseguró que no tenía síntomas de la COVID-19.

Varios estudios han puesto en tela de juicio la efectividad de la hidroxicloroquina, como el publicado el pasado 22 de mayo por la prestigiosa revista británica The Lancet, con datos de cientos de hospitales y que involucró a 90.000 pacientes hospitalizados por infección con coronavirus de todo el mundo.

Ese informe determinó que quienes recibieron hidroxicloroquina, o el compuesto relacionado cloroquina, tenían un riesgo de muerte significativamente mayor que quienes no recibieron el tratamiento.

Días después de la publicación del estudio, la Organización Mundial de la Salud (OMS) anunció que detenía temporalmente los ensayos clínicos con hidroxicloroquina enmarcados en su ensayo Solidarity.

Sin embargo, poco después, tres de los cuatro autores de ese estudio decidieron retractarse por las «varias preocupaciones con respecto a la veracidad de los datos y análisis» presentados en el documento.

Estados Unidos tiene 115,827 muertos confirmados de la COVID-19, de acuerdo con el recuento independiente de la Universidad Johns Hopkins.


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