{"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":"fda-phenylephrinentfernung","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/fda-phenylephrine-removal\/","title":{"rendered":"FDA erl\u00e4sst vorgeschlagene Anordnung zur Abschaffung von oralem Phenylephrin \u2026"},"content":{"rendered":"<p>Die US-amerikanische Food and Drug Administration (FDA) hat heute einen Vorschlag zur Abschaffung von oralem Phenylephrin als zugelassenen Wirkstoff in <a href=\"https:\/\/regask.com\/de\/beweise-aus-der-praxis-fur-rezeptfreie-behauptungen\/\">\u00fcber den Ladentisch<\/a> (OTC)-Monographie-Arzneimittel zur vor\u00fcbergehenden Linderung von verstopfter Nase. Nach eingehender Pr\u00fcfung der vorhandenen Daten stellte die FDA fest, dass orales Phenylephrin als Nasenabschwellmittel nicht wirksam ist. Hersteller d\u00fcrfen vorerst weiterhin OTC-Produkte mit oralem Phenylephrin verkaufen. Sollte dieser Verordnungsvorschlag jedoch endg\u00fcltig sein, w\u00fcrde erst eine sp\u00e4tere endg\u00fcltige Verordnung die Vermarktung dieser Produkte einschr\u00e4nken.<\/p>\n<p>Phenylephrin zum Einnehmen ist derzeit ein h\u00e4ufiger Bestandteil vieler rezeptfreier Nasenabschwellmittel, manchmal als einzelner Wirkstoff und manchmal in Kombination mit anderen Inhaltsstoffen wie Paracetamol oder Dextromethorphan, die von dieser vorgeschlagenen \u00c4nderung nicht betroffen sind.<\/p>\n<p>\u201eIm Rahmen der FDA-Mission, die Sicherheit und Wirksamkeit von Arzneimitteln zu gew\u00e4hrleisten, verfolgen wir diesen Vorschlag, orales Phenylephrin als Nasenabschwellmittel zu entfernen\u201c, sagte Dr. Patrizia Cavazzoni, Direktorin des Center for Drug Evaluation and Research (CDER) der FDA. \u201eUnsere \u00dcberpr\u00fcfung steht im Einklang mit der Schlussfolgerung des Nonprescription Drug Advisory Committee, dass orales Phenylephrin eine verstopfte Nase nicht wirksam lindert.\u201c<\/p>\n<p>Die FDA pr\u00fcfte umfassende Daten, darunter historische und aktuelle klinische Studien, um die Wirksamkeit von oral verabreichtem Phenylephrin zu beurteilen. Im vergangenen Herbst berief die FDA eine Beratungsausschusssitzung ein, um den Status von oral verabreichtem Phenylephrin als \u201eallgemein als sicher und wirksam anerkanntes\u201c (GRASE) Mittel zur Nasenabschwellung zu er\u00f6rtern. Der Ausschuss kam einstimmig zu dem Schluss, dass aktuelle wissenschaftliche Daten die Wirksamkeit von oral verabreichtem Phenylephrin in empfohlenen rezeptfreien Dosierungen nicht belegen.<\/p>\n<p>\u201eVerbraucher sollten sich bewusst sein, dass es verschiedene sichere und wirksame Behandlungsm\u00f6glichkeiten f\u00fcr eine verstopfte Nase bei Erk\u00e4ltungen oder Allergien gibt\u201c, sagte Dr. Theresa Michele, Leiterin des Office of Nonprescription Drug Products im CDER. \u201ePatienten sollten ihren Arzt oder Apotheker konsultieren, um wirksame M\u00f6glichkeiten zur Linderung der Symptome zu finden.\u201c<\/p>\n<p>Die FDA empfiehlt Verbrauchern, die Packungsbeilage zu lesen, um die Inhaltsstoffe zu best\u00e4tigen und wichtige Anwendungshinweise zu verstehen, insbesondere da einige Produkte zwar den gleichen Markennamen tragen, aber unterschiedliche Inhaltsstoffe enthalten. Wichtig ist auch, dass diese vorgeschlagene Ma\u00dfnahme nur oral verabreichtes Phenylephrin betrifft, nicht Phenylephrin in Form von Nasenspray.<\/p>\n<p>Die FDA bittet derzeit um \u00f6ffentliche Stellungnahmen zu diesem Verordnungsvorschlag. Hinweise zur Stellungnahme finden Sie unter OTC Monographs@FDA. Sollte die FDA die Verordnung finalisieren, h\u00e4tten die Hersteller Zeit, die Formulierung von Produkten mit oralem Phenylephrin als Nasenabschwellmittel zu \u00e4ndern oder vom Markt zu nehmen.<\/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\/de\/fda-phenylephrinentfernung\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\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. Learn about the potential impact on over-the-counter medications.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/de\/fda-phenylephrinentfernung\/\" \/>\n<meta property=\"og:site_name\" content=\"RegASK\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/\" \/>\n<meta property=\"article:published_time\" content=\"2024-11-13T04:38:43+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-11-21T01:19:30+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2024\/11\/fda-issues-proposed-order-remove-oral-phenylephrine-otc-nasal-decongestants-seeks-public-comment.png\" \/>\n\t<meta property=\"og:image:width\" content=\"800\" \/>\n\t<meta property=\"og:image:height\" content=\"600\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Amandine Tricou\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:site\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Amandine Tricou\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2\u00a0Minuten\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/regask.com\\\/fda-phenylephrine-removal\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-phenylephrine-removal\\\/\"},\"author\":{\"name\":\"Amandine Tricou\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/c2135b6dbdb95b0886564618fe9f4108\"},\"headline\":\"FDA Issues Proposed Order to Remove Oral Phenylephrine &hellip;\",\"datePublished\":\"2024-11-13T04:38:43+00:00\",\"dateModified\":\"2024-11-21T01:19:30+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-phenylephrine-removal\\\/\"},\"wordCount\":426,\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-phenylephrine-removal\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2024\\\/11\\\/fda-issues-proposed-order-remove-oral-phenylephrine-otc-nasal-decongestants-seeks-public-comment.png\",\"keywords\":[\"OTC regulations\",\"Drug Ingredients regulations\"],\"articleSection\":[\"Pharma and Biotech\"],\"inLanguage\":\"de\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/regask.com\\\/fda-phenylephrine-removal\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/fda-phenylephrine-removal\\\/\",\"name\":\"FDA Proposes Removing Phenylephrine Nasal Decongestants\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-phenylephrine-removal\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/fda-phenylephrine-removal\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2024\\\/11\\\/fda-issues-proposed-order-remove-oral-phenylephrine-otc-nasal-decongestants-seeks-public-comment.png\",\"datePublished\":\"2024-11-13T04:38:43+00:00\",\"dateModified\":\"2024-11-21T01:19:30+00:00\",\"description\":\"The FDA is considering removing phenylephrine from nasal decongestants. 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