{"id":3413,"date":"2018-07-09T14:48:09","date_gmt":"2018-07-09T18:48:09","guid":{"rendered":"http:\/\/www.asapofanderson.org\/?p=3413"},"modified":"2018-07-09T14:48:09","modified_gmt":"2018-07-09T18:48:09","slug":"from-the-director-fda-approves-epidolex","status":"publish","type":"post","link":"https:\/\/asapofanderson.org\/es\/from-the-director-fda-approves-epidolex\/","title":{"rendered":"DEL DIRECTOR: LA FDA APRUEBA EPIDOLEX"},"content":{"rendered":"<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p><strong>LA FDA APRUEBA EPIDOLEX\u00ae, UNA FORMA PURIFICADA DE CBD: \u00bfEN QU\u00c9 SE DIFERENCIA DE OTROS PRODUCTOS DE CBD?<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>La \u00faltima semana de junio, la Administraci\u00f3n de Alimentos y Medicamentos de EE.UU. (FDA) aprob\u00f3 Epidolex\u00ae, una soluci\u00f3n oral de cannabidiol (CBD) para tratar las crisis asociadas a la epilepsia, incluidos el s\u00edndrome de Lennox-Gastaut y el s\u00edndrome de Dravet, en pacientes de dos a\u00f1os o m\u00e1s. El CBD es un componente qu\u00edmico de la planta Cannabis sativa, tambi\u00e9n conocida como marihuana. El CBD no provoca la intoxicaci\u00f3n ni la euforia (tambi\u00e9n conocida como \u201csubid\u00f3n\u201d) que produce el tetrahidrocannabinol (THC), que es la sustancia psicoactiva de la marihuana.<\/p>\n<p>&nbsp;<\/p>\n<p>Se trata del primer medicamento aprobado por la FDA que contiene una sustancia purificada derivada de la marihuana. El Comisionado de la FDA, el Dr. Scott Gottleib, dijo que \u201cla FDA est\u00e1 comprometida con este tipo de investigaci\u00f3n cient\u00edfica cuidadosa y el desarrollo de f\u00e1rmacos... Los ensayos cl\u00ednicos controlados que prueban la seguridad y eficacia de un f\u00e1rmaco, junto con una revisi\u00f3n cuidadosa a trav\u00e9s del proceso de aprobaci\u00f3n de medicamentos de la FDA, es la forma m\u00e1s adecuada de llevar los tratamientos derivados de la marihuana a los pacientes.\u201d El Dr. Gottleib continu\u00f3 diciendo que \u201clos prescriptores pueden tener confianza en la potencia uniforme del f\u00e1rmaco y en la administraci\u00f3n consistente que apoyan la dosificaci\u00f3n apropiada necesaria para tratar a los pacientes.\u201d<sup>1<\/sup><\/p>\n<p>&nbsp;<\/p>\n<p>Por el contrario, muchos productos de CBD no regulados son legales en varios estados, incluido Tennessee, a pesar de que no han sido aprobados por la FDA como seguros o eficaces. Recientemente, 52 personas resultaron intoxicadas en Utah por un producto de CBD no regulado, lo que provoc\u00f3 que tanto la FDA como los Centros para el Control y la Prevenci\u00f3n de Enfermedades (CDC) emitieran una alerta advirtiendo a la poblaci\u00f3n de los peligros de consumir productos no regulados etiquetados como CBD.<sup>2<\/sup><\/p>\n<p>&nbsp;<\/p>\n<p>Una comparaci\u00f3n entre Epidolex\u00ae y otros productos de CBD muestra una variaci\u00f3n significativa. Mientras que los m\u00e9dicos est\u00e1n legalmente autorizados a recetar Epidolex\u00ae, s\u00f3lo pueden recomendar productos de CBD. Los pacientes comprar\u00edan Epidolex\u00ae en una farmacia y tendr\u00edan instrucciones espec\u00edficas de dosificaci\u00f3n, mientras que el CBD se compra a trav\u00e9s de un dispensario sin instrucciones espec\u00edficas de dosificaci\u00f3n. Epidolex\u00ae es un extracto purificado de marihuana, que contiene 99% de CBD y menos de 1% de THC: se descubri\u00f3 que los productos de CBD no regulados no estaban purificados y conten\u00edan hasta 20% de CBD. Se descubri\u00f3 que muchos productos de CBD no regulados conten\u00edan THC y otros contaminantes.<sup>3<\/sup><\/p>\n<p>&nbsp;<\/p>\n<p>La FDA ha aprobado anteriormente Marinol\u00ae (aprobado en 1985), Cesamet\u00ae (aprobado en 1985) y Syndros\u00ae (aprobado en 2017), formulaciones de THC que se han recetado para tratar las n\u00e1useas y los v\u00f3mitos asociados a la quimioterapia contra el c\u00e1ncer y la anorexia y la p\u00e9rdida de peso asociadas al sida.<sup>4\u00a0<\/sup>Para m\u00e1s informaci\u00f3n sobre Epidolex\u00ae, visite <a href=\"https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/210365lbl.pdf\">https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/210365lbl.pdf<\/a>.<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<h6>1 \u201cLa FDA aprueba el primer medicamento compuesto por un ingrediente activo derivado de la marihuana para tratar formas raras y graves de epilepsia.\u201d Comunicado de prensa de la FDA-25 de junio de 2018. DOI: https:\/\/www.fda.gov\/NewsEvents\/Newsroom\/PressAnnouncements \/ucm611046.htm.<\/h6>\n<h6>2 Horth RZ, Crouch B, Horowitz BZ, et al.\u00a0<em>Notas desde el terreno:<\/em>\u00a0Intoxicaciones agudas por un cannabinoide sint\u00e9tico vendido como cannabidiol - Utah, 2017-2018. MMWR Morb Mortal Wkly Rep 2018;67:587-588. DOI:\u00a0<a href=\"http:\/\/dx.doi.org\/10.15585\/mmwr.mm6720a5\">http:\/\/dx.doi.org\/10.15585\/mmwr.mm6720a5<\/a>.<\/h6>\n<h6>3 \u201cEl informe sobre la marihuana\u201d. Familias nacionales en acci\u00f3n. 27 de junio de 2018.<\/h6>\n<h6>4 \u201cYa existen productos farmac\u00e9uticos; se llaman Marinol y Cesament\u201d. Bolet\u00edn de la DEA. DOI: https:\/\/www.dea.gov\/divisions\/sea\/in_focus\/marinol-cessmet.pdf.<\/h6>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>","protected":false},"excerpt":{"rendered":"<p>&nbsp; &nbsp; FDA APPROVES EPIDOLEX\u00ae, A PURIFIED FORM OF CBD: HOW IS IT DIFFERENT FROM OTHER CBD PRODUCTS? &nbsp; &nbsp; The last week of June, the U.S. Food and Drug Administration (FDA) approved Epidolex\u00ae, a cannabidiol (CBD) oral solution to treat seizures associated with epilepsy, including Lennox-Gastaut syndrome and Dravet syndrome, for patients two years [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[6],"tags":[],"class_list":["post-3413","post","type-post","status-publish","format-standard","hentry","category-newsletter"],"blocksy_meta":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>FROM THE DIRECTOR: FDA APPROVES EPIDOLEX\u00ae - 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