{"id":7794,"date":"2024-11-13T12:38:43","date_gmt":"2024-11-13T04:38:43","guid":{"rendered":"https:\/\/regask.com\/?p=7794"},"modified":"2024-11-21T09:19:30","modified_gmt":"2024-11-21T01:19:30","slug":"eliminacion-de-fenilefrina-por-la-fda","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/fda-phenylephrine-removal\/","title":{"rendered":"La FDA emite una orden propuesta para eliminar la fenilefrina oral\u2026"},"content":{"rendered":"<p>La Administraci\u00f3n de Alimentos y Medicamentos de los Estados Unidos (FDA) anunci\u00f3 hoy una propuesta para eliminar la fenilefrina oral como ingrediente activo aprobado en <a href=\"https:\/\/regask.com\/es\/evidencia-del-mundo-real-sobre-afirmaciones-de-venta-libre\/\">en el mostrador<\/a> Medicamentos monogr\u00e1ficos de venta libre (OTC) utilizados para el alivio temporal de la congesti\u00f3n nasal. Tras una revisi\u00f3n detallada de los datos existentes, la FDA determin\u00f3 que la fenilefrina oral no es eficaz como descongestionante nasal. Por el momento, los fabricantes pueden seguir vendiendo productos de venta libre que contengan fenilefrina oral. Sin embargo, si se aprueba esta orden propuesta, solo una orden final posterior restringir\u00eda la comercializaci\u00f3n de estos productos.<\/p>\n<p>La fenilefrina oral es actualmente un ingrediente com\u00fan en muchos descongestionantes nasales de venta libre, a veces como ingrediente activo \u00fanico y otras veces combinado con otros ingredientes, como acetaminofeno o dextrometorfano, que no se ver\u00e1n afectados por este cambio propuesto.<\/p>\n<p>\u201cComo parte de la misi\u00f3n de la FDA de garantizar la seguridad y eficacia de los medicamentos, estamos avanzando con esta propuesta para eliminar la fenilefrina oral como descongestionante nasal\u201d, declar\u00f3 la Dra. Patrizia Cavazzoni, directora del Centro de Evaluaci\u00f3n e Investigaci\u00f3n de Medicamentos (CDER) de la FDA. \u201cNuestra revisi\u00f3n coincide con la conclusi\u00f3n del Comit\u00e9 Asesor de Medicamentos sin Receta de que la fenilefrina oral no alivia eficazmente la congesti\u00f3n nasal\u201d.<\/p>\n<p>La FDA revis\u00f3 un conjunto exhaustivo de datos, incluyendo estudios cl\u00ednicos hist\u00f3ricos y recientes, para evaluar la eficacia de la fenilefrina oral. El oto\u00f1o pasado, la FDA celebr\u00f3 una reuni\u00f3n de su comit\u00e9 asesor para debatir la condici\u00f3n de la fenilefrina oral como ingrediente &quot;Generalmente Reconocido como Seguro y Eficaz&quot; (GRASE) para la descongesti\u00f3n nasal. La conclusi\u00f3n un\u00e1nime del comit\u00e9 fue que los datos cient\u00edficos actuales no respaldan la eficacia de la fenilefrina oral en las dosis recomendadas de venta libre.<\/p>\n<p>\u201cLos consumidores deben saber que existen diversos tratamientos seguros y eficaces para aliviar la congesti\u00f3n nasal causada por resfriados comunes o alergias\u201d, afirm\u00f3 la Dra. Theresa Michele, directora de la Oficina de Medicamentos sin Receta del CDER. \u201cLos pacientes deben consultar a su m\u00e9dico o farmac\u00e9utico para encontrar opciones eficaces para el alivio de los s\u00edntomas\u201d.<\/p>\n<p>La FDA recomienda a los consumidores leer la etiqueta de informaci\u00f3n farmacol\u00f3gica para confirmar los ingredientes y comprender las instrucciones de uso importantes, especialmente porque algunos productos pueden tener la misma marca pero contener ingredientes diferentes. Es fundamental tener en cuenta que esta medida propuesta solo afecta a la fenilefrina administrada por v\u00eda oral, no a la fenilefrina en aerosol nasal.<\/p>\n<p>La FDA est\u00e1 solicitando comentarios del p\u00fablico sobre esta orden propuesta. Las instrucciones para enviar comentarios est\u00e1n disponibles en OTC Monographs@FDA. Si la FDA decide finalizar la orden, se les dar\u00e1 tiempo a los fabricantes para reformular o retirar del mercado los productos con fenilefrina oral como descongestionante nasal.<\/p>","protected":false},"excerpt":{"rendered":"<p>The U.S. Food and Drug Administration (FDA) announced today a proposal to eliminate oral phenylephrine as an approved active ingredient in over-the-counter (OTC) monograph drug products used for temporary nasal congestion relief. Following a detailed review of existing data, the FDA determined that oral phenylephrine is not effective as a nasal decongestant. For the time&#8230;<\/p>","protected":false},"author":30,"featured_media":7810,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[35],"tags":[600,601],"class_list":["post-7794","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharma-biotech-latest-insights","tag-otc-regulations","tag-drug-ingredients-regulations"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.2 (Yoast SEO v27.3) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FDA Proposes Removing Phenylephrine Nasal Decongestants<\/title>\n<meta name=\"description\" content=\"The FDA is considering removing phenylephrine from nasal decongestants. Learn about the potential impact on over-the-counter medications.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/regask.com\/es\/eliminacion-de-fenilefrina-por-la-fda\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA Issues Proposed Order to Remove Oral Phenylephrine from OTC Nasal Decongestants and Seeks Public Comment\" \/>\n<meta property=\"og:description\" content=\"The FDA is considering removing phenylephrine from nasal decongestants. 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