Salud
La FDA aprobó la primera píldora para la depresión posparto
La Administración de Alimentos y Medicamentos aprobó la primera píldora diseñada específicamente para tratar la depresión posparto, una afección común que afecta a las madres y que puede dificultar el vínculo con un nuevo bebé al causar desesperación severa, ansiedad, vergüenza, ataques de pánico y pensamientos suicidas .El medicamento, Zurzuvae, está diseñado para tomarse una vez al día durante dos semanas después del embarazo, un período mucho más corto que los tratamientos actualmente implementados, como los antidepresivos o la terapia de conversación, que no son específicos para la depresión posparto. Los funcionarios federales de salud dijeron que esperan que la píldora anime a más madres primerizas a buscar ayuda para la afección, que afecta a unas 400.000 personas al año. Si no se tratan, los síntomas pueden desaparecer por sí solos en unas semanas, pero a veces pueden persistir durante meses o incluso años.
El único otro medicamento diseñado específicamente para la depresión posparto no es una píldora y es difícil de conseguir: requiere una infusión intravenosa de 60 horas en un hospital, puede causar pérdida del conocimiento y cuesta $34,000.»Tener acceso a un medicamento oral será una opción beneficiosa para muchas de estas mujeres que se enfrentan a sentimientos extremos y, a veces, que amenazan la vida», dijo la Dra. Tiffany Farchione, líder de la división de la FDA que aprobó la píldora, en un comunicado del viernes. declaración.Zurzuvae fue desarrollado por Sage Therapeutics, la misma empresa detrás del tratamiento intravenoso, y se produce en sociedad con la firma Biogen. Se espera que esté disponible después de una revisión de 90 días por parte de la Administración de Control de Drogas, aunque las compañías no han revelado cuánto costará.A diferencia de muchos antidepresivos que se enfocan en los niveles de serotonina del cerebro, Zurzuvae imita un derivado de la progesterona, una hormona que se produce en niveles más altos durante el embarazo, pero que disminuye drásticamente después del parto. En dos ensayos clínicos financiados por la compañía que en conjunto involucraron a 350 pacientes, la mayoría de los que recibieron la píldora experimentaron una mejora significativa, algunos en solo tres días. Dentro de los 15 días, se consideró que muchas de ellas estaban en remisión de su depresión posparto. Los beneficios duraron a través de las pruebas de 45 días.
Para evaluar la eficacia y el impacto a largo plazo del fármaco, los investigadores recomiendan estudios durante un período de tiempo mayor. La FDA también advirtió que la píldora puede causar efectos secundarios, como somnolencia o mareos, e incluso pensamientos suicidas.Aún así, los expertos en salud son optimistas de que la mayor disponibilidad de la píldora y el hecho de que la vía del fármaco aborde los cambios hormonales medibles que conducen a la depresión posparto reducirán el estigma en torno a la afección.“Da a entender que hay una razón biológica para lo que sientes en este momento”, dijo al New York Times Wendy Davis, directora ejecutiva de la organización sin fines de lucro Postpartum Support International . «No es tu culpa.»
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