{"id":420,"date":"2021-06-08T14:27:21","date_gmt":"2021-06-08T14:27:21","guid":{"rendered":"https:\/\/www.janiceklaw.com\/blog\/fda-approves-controversial-alzheimers-drug\/"},"modified":"2022-11-10T23:18:15","modified_gmt":"2022-11-10T23:18:15","slug":"la-fda-aprueba-un-controvertido-farmaco-contra-el-alzheimer","status":"publish","type":"post","link":"https:\/\/www.janiceklaw.com\/es\/blog\/fda-approves-controversial-alzheimers-drug\/","title":{"rendered":"FDA aprueba pol\u00e9mico f\u00e1rmaco contra el Alzheimer"},"content":{"rendered":"

Cada uno tiene su umbral de riesgo y, obviamente, las circunstancias contribuir\u00e1n a la toma de decisiones. Las circunstancias que rodearon la aprobaci\u00f3n por parte de la Administraci\u00f3n de Alimentos y Medicamentos de Aducanumab fabricado por Biogen hecho noticia nacional<\/a>. Es emocionante para muchos porque el f\u00e1rmaco es el primer f\u00e1rmaco nuevo para el Alzheimer aprobado por la FDA en casi 20 a\u00f1os.<\/p>\n

C\u00f3mo funciona<\/h2>\n

Se supone que el f\u00e1rmaco ralentiza la progresi\u00f3n de la enfermedad de Alzheimer porque, seg\u00fan los informes, ha demostrado ser muy eficaz para reducir las placas llamadas beta-amiloide. Estas placas se acumulan en los cerebros de las personas con Alzheimer. Por lo general, esto ser\u00eda una gran noticia.<\/p>\n

Algunos detalles preocupantes<\/h2>\n

Hay varias banderas rojas a tener en cuenta:<\/p>\n

    \n
  1. Un panel de asesores expertos de la FDA recomend\u00f3 no aprobar el medicamento en noviembre de 2020.<\/li>\n
  2. Dos grandes estudios ofrecieron resultados contradictorios con respecto a la eficacia del f\u00e1rmaco.<\/li>\n
  3. La FDA exigi\u00f3 a Biogen que realizara un nuevo estudio para ver si reduce las placas, lo que luego lleva a una mejor\u00eda del paciente. Este estudio fue una condici\u00f3n para la aprobaci\u00f3n acelerada del f\u00e1rmaco por parte de la FDA.<\/li>\n
  4. La aprobaci\u00f3n inestable de la FDA puede hacer que algunos eviten usar el medicamento, lo que limita el grupo de estudio. Por el contrario, es posible que algunos no quieran arriesgarse a recibir el placebo como parte del estudio y evitar el estudio.<\/li>\n
  5. Podr\u00edan pasar varios a\u00f1os antes de que finalicen los ensayos cl\u00ednicos del medicamento.<\/li>\n
  6. Un an\u00e1lisis independiente de un tercero tambi\u00e9n analiz\u00f3 los estudios y no encontr\u00f3 evidencia de que los beneficios del f\u00e1rmaco superaran el da\u00f1o.<\/li>\n
  7. El controvertido tratamiento farmacol\u00f3gico cuesta $56,000 por a\u00f1o.<\/li>\n<\/ol>\n

    Los cr\u00edticos cuestionan el uso<\/h2>\n

    Un doctor en medicina y \u00e9tica m\u00e9dica habl\u00f3 por algunos cuando critic\u00f3 la droga<\/a>, citando el costo, la falta de beneficios claros y los riesgos de sangrado en el cerebro causados por el tratamiento. Las familias de seres queridos con Alzheimer tambi\u00e9n deben tener cuidado con este medicamento. Seg\u00fan el impacto del medicamento en el paciente, es posible que las familias deban presentar una demanda por lesiones por drogas.<\/a><\/p>","protected":false},"excerpt":{"rendered":"

    Everyone has their risk threshold, and obviously, circumstances will contribute to the decision-making process. The circumstances surrounding the Food and Drug Administration\u2019s approval of Aducanumab manufactured by Biogen made national news. It is exciting to many because the drug is the first new Alzheimer\u2019s drug approved by the FDA in nearly 20 years. How it […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[38],"tags":[],"class_list":["post-420","post","type-post","status-publish","format-standard","hentry","category-defective-medications"],"yoast_head":"\nFDA approves controversial Alzheimer\u2019s drug | Janicek Law<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.janiceklaw.com\/es\/blog\/la-fda-aprueba-un-controvertido-farmaco-contra-el-alzheimer\/\" \/>\n<meta property=\"og:locale\" content=\"es_MX\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA approves controversial Alzheimer\u2019s drug | Janicek Law\" \/>\n<meta property=\"og:description\" content=\"Everyone has their risk threshold, and obviously, circumstances will contribute to the decision-making process. The circumstances surrounding the Food and Drug Administration\u2019s approval of Aducanumab manufactured by Biogen made national news. It is exciting to many because the drug is the first new Alzheimer\u2019s drug approved by the FDA in nearly 20 years. 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