{"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":"suppression-de-la-phenylephrine-par-la-fda","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/fda-phenylephrine-removal\/","title":{"rendered":"La FDA \u00e9met un projet d\u2019ordonnance visant \u00e0 supprimer la ph\u00e9nyl\u00e9phrine orale\u2026"},"content":{"rendered":"<p>La Food and Drug Administration (FDA) des \u00c9tats-Unis a annonc\u00e9 aujourd&#039;hui une proposition visant \u00e0 \u00e9liminer la ph\u00e9nyl\u00e9phrine orale en tant qu&#039;ingr\u00e9dient actif approuv\u00e9 dans <a href=\"https:\/\/regask.com\/fr\/preuves-du-monde-reel-allegations-de-gre-a-gre\/\">sur le comptoir<\/a> (OTC) m\u00e9dicaments monographiques utilis\u00e9s pour soulager temporairement la congestion nasale. Apr\u00e8s un examen d\u00e9taill\u00e9 des donn\u00e9es existantes, la FDA a d\u00e9termin\u00e9 que la ph\u00e9nyl\u00e9phrine orale n&#039;est pas efficace comme d\u00e9congestionnant nasal. Pour le moment, les fabricants peuvent continuer \u00e0 vendre des produits en vente libre contenant de la ph\u00e9nyl\u00e9phrine orale. Cependant, si cette proposition d&#039;ordonnance est finalis\u00e9e, seule une ordonnance finale ult\u00e9rieure limiterait la commercialisation de ces produits.<\/p>\n<p>La ph\u00e9nyl\u00e9phrine orale est actuellement un ingr\u00e9dient courant dans de nombreux d\u00e9congestionnants nasaux en vente libre, parfois en tant qu\u2019ingr\u00e9dient actif unique et \u00e0 d\u2019autres moments en association avec d\u2019autres ingr\u00e9dients, tels que l\u2019ac\u00e9taminoph\u00e8ne ou le dextrom\u00e9thorphane, qui ne sont pas affect\u00e9s par ce changement propos\u00e9.<\/p>\n<p>\u00ab Dans le cadre de la mission de la FDA visant \u00e0 garantir la s\u00e9curit\u00e9 et l&#039;efficacit\u00e9 des m\u00e9dicaments, nous allons de l&#039;avant avec cette proposition visant \u00e0 supprimer la ph\u00e9nyl\u00e9phrine orale comme d\u00e9congestionnant nasal \u00bb, a d\u00e9clar\u00e9 le Dr Patrizia Cavazzoni, directrice du Centre d&#039;\u00e9valuation et de recherche sur les m\u00e9dicaments (CDER) de la FDA. \u00ab Notre examen concorde avec la conclusion du Comit\u00e9 consultatif sur les m\u00e9dicaments en vente libre selon laquelle la ph\u00e9nyl\u00e9phrine orale ne soulage pas efficacement la congestion nasale. \u00bb<\/p>\n<p>La FDA a examin\u00e9 un ensemble complet de donn\u00e9es, notamment des \u00e9tudes cliniques historiques et r\u00e9centes, pour \u00e9valuer l&#039;efficacit\u00e9 de la ph\u00e9nyl\u00e9phrine orale. L&#039;automne dernier, la FDA a tenu une r\u00e9union du comit\u00e9 consultatif pour discuter du statut de la ph\u00e9nyl\u00e9phrine orale en tant qu&#039;ingr\u00e9dient \u00ab g\u00e9n\u00e9ralement reconnu comme s\u00fbr et efficace \u00bb (GRASE) pour la d\u00e9congestion nasale. La conclusion unanime du comit\u00e9 a \u00e9t\u00e9 que les donn\u00e9es scientifiques actuelles ne soutiennent pas l&#039;efficacit\u00e9 de la ph\u00e9nyl\u00e9phrine orale aux doses recommand\u00e9es en vente libre.<\/p>\n<p>\u00ab Les consommateurs doivent savoir qu\u2019il existe plusieurs traitements s\u00fbrs et efficaces pour soulager la congestion nasale caus\u00e9e par le rhume ou les allergies \u00bb, a d\u00e9clar\u00e9 la Dre Theresa Michele, directrice du Bureau des m\u00e9dicaments en vente libre du CDER. \u00ab Les patients doivent consulter leur m\u00e9decin ou leur pharmacien pour trouver des options efficaces de soulagement des sympt\u00f4mes. \u00bb<\/p>\n<p>La FDA encourage les consommateurs \u00e0 lire l&#039;\u00e9tiquette des informations sur le m\u00e9dicament pour confirmer les ingr\u00e9dients et comprendre les instructions d&#039;utilisation importantes, d&#039;autant plus que certains produits peuvent partager le m\u00eame nom de marque mais contenir des ingr\u00e9dients diff\u00e9rents. Il est \u00e9galement essentiel de noter que cette mesure propos\u00e9e ne concerne que la ph\u00e9nyl\u00e9phrine administr\u00e9e par voie orale, et non la ph\u00e9nyl\u00e9phrine sous forme de vaporisateur nasal.<\/p>\n<p>La FDA sollicite actuellement les commentaires du public sur cette proposition d&#039;ordonnance. Les instructions pour soumettre des commentaires sont disponibles sur OTC Monographs@FDA. Si la FDA d\u00e9cide de finaliser l&#039;ordonnance, les fabricants auront le temps de reformuler ou de retirer du march\u00e9 les produits contenant de la ph\u00e9nyl\u00e9phrine orale comme d\u00e9congestionnant 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 v27.5 (Yoast SEO v27.5) - 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\/fr\/suppression-de-la-phenylephrine-par-la-fda\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\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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