{"id":7666,"date":"2023-03-09T12:58:45","date_gmt":"2023-03-09T09:58:45","guid":{"rendered":"https:\/\/urbancare.clinic\/swiss-makers-to-voluntarily-pull-their-unproven-birth-drug-makena-from-market\/"},"modified":"2023-03-09T12:58:45","modified_gmt":"2023-03-09T09:58:45","slug":"schweizer-hersteller-verpflichten-sich-ihr-unbewiesenes-geburtsmedikament-makena-freiwillig-vom-markt-zu-nehmen","status":"publish","type":"post","link":"https:\/\/urbancare.clinic\/de\/schweizer-hersteller-verpflichten-sich-ihr-unbewiesenes-geburtsmedikament-makena-freiwillig-vom-markt-zu-nehmen\/","title":{"rendered":"Schweizer Hersteller nehmen ihr unbewiesenes Geburtsmedikament Makena freiwillig vom Markt"},"content":{"rendered":"
<\/div>\n

Der Hersteller eines noch nicht erprobten Medikaments, Makena, hat erkl\u00e4rt, dass er das Produkt freiwillig aus den USA entfernen wird. Das von Covis Pharma mit Sitz in der Schweiz hergestellte Medikament soll Fr\u00fchgeburten verhindern. <\/p>\n

Das gab das Unternehmen am Dienstag bekannt abc Nachrichten<\/a>. Die Entscheidung, das Medikament abzusetzen, f\u00e4llt nach fast vier Jahren, da Makena keinen Nutzen f\u00fcr die Unterst\u00fctzung von M\u00fcttern beim Austragen einer Schwangerschaft nachweisen konnte.<\/p>\n

Makena ist eine synthetische Version des Hormons Progesteron, das f\u00fcr die Aufrechterhaltung einer Schwangerschaft unerl\u00e4sslich ist. Es ist au\u00dferdem das einzige von der FDA zugelassene Medikament, das das Risiko einer Fr\u00fchgeburt senkt.<\/p>\n

Das durch Injektion eingenommene Medikament ist das Aush\u00e4ngeschild der Herausforderungen, denen sich die FDA stellen muss, um ein Medikament vom Markt zu nehmen, wenn der Hersteller nicht zustimmt.<\/p>\n

<\/div>\n

Der Zeitplan f\u00fcr die R\u00fccknahme des Medikaments vom Markt bleibt unklar. Covis sagte in seiner Pressemitteilung, dass die Aufsichtsbeh\u00f6rden der FDA ihren Vorschlag, den Drogenkonsum \u00fcber mehrere Monate hinweg einzuschr\u00e4nken, abgelehnt h\u00e4tten.<\/p>\n

Das Unternehmen sagte, die Verl\u00e4ngerung w\u00fcrde es Frauen, die das Rezept erhalten, erm\u00f6glichen, ihre Behandlung, die nach der 16. Schwangerschaftswoche beginnt, zu beenden.<\/p>\n

Allerdings empfahlen die Arzneimittelaufsichtsbeh\u00f6rden der FDA in einer separaten Einreichung am Mittwoch nachdr\u00fccklich, den Entzug \u201esofort wirksam\u201c zu machen, so die Verkaufsstelle. Die Agentur f\u00fcgte hinzu, dass durch das Absetzen von Makena kein vern\u00fcnftiger \u201eSchaden entstanden sei, etwa Anzeichen oder Symptome eines Entzugs\u201c.<\/p>\n

Alles begann im Oktober in einer \u00f6ffentlichen Sitzung, als externe Berater zu dem Schluss kamen, dass Makena seine Wirksamkeit nicht nachweisen k\u00f6nne und seine Zulassung widerrufen werden sollte. Das Gremium war trotz stundenlanger Pr\u00e4sentationen und Debatten, die Covis vorgebracht hatte, um zu beweisen, dass das Medikament f\u00fcr eine Untergruppe von Frauen n\u00fctzlich sein k\u00f6nnte, nicht \u00fcberzeugt.<\/p>\n

Es ist zu beachten, dass Anh\u00f6rungen wie diese sehr selten sind und nur dann stattfinden, wenn ein Arzneimittelhersteller sich den anf\u00e4nglichen Antr\u00e4gen der FDA zur Entfernung seines Arzneimittels widersetzt.<\/p>\n

\u201eObwohl wir zum g\u00fcnstigen Nutzen-Risiko-Profil von Makena stehen, einschlie\u00dflich seiner Wirksamkeit bei Frauen mit dem h\u00f6chsten Fr\u00fchgeburtsrisiko, versuchen wir, das Produkt freiwillig vom Markt zu nehmen und mit der FDA zusammenzuarbeiten, um eine geordnete Abwicklung herbeizuf\u00fchren\u201c, sagte Raghav Chari, Der Chief Information Officer von Covis sagte in einer Erkl\u00e4rung: CBS-Nachrichten<\/a> gemeldet.<\/p>\n

Der Arzneimittelhersteller sagte, er sei \u201eweiterhin bereit, mit der Beh\u00f6rde zusammenzuarbeiten\u201c, obwohl der Zeitrahmen feststecke.<\/p>\n

Makena erhielt 2011 von der FDA eine beschleunigte Zulassung. Die Entscheidung basierte auf einer kleinen Studie mit Frauen, die in der Vergangenheit Fr\u00fchgeburten hatten. Die Zulassung erfolgte unter der Bedingung, dass eine gr\u00f6\u00dfere Folgestudie durchgef\u00fchrt wird, um die Wirksamkeit des Arzneimittels zu best\u00e4tigen.<\/p>\n

Im Jahr 2019 ergab eine internationale Studie mit 1.700 Patienten das Arzneimittel<\/a> weder die Zahl der Fr\u00fchgeburten verringert noch eine ges\u00fcndere Entwicklung f\u00fcr die Babys bewirkt.<\/p>\n

Ungeachtet der Ergebnisse sind Reproduktionsspezialisten, darunter Mitglieder des American College of Obstetricians and Gynecologists, daf\u00fcr, das w\u00f6chentlich injizierte Medikament auf dem Markt zu belassen, bis weitere Forschungen durchgef\u00fchrt werden.<\/p>\n

Die Gruppe gab an, dass ihre Richtlinien g\u00fcltig bleiben, bis die FDA eine endg\u00fcltige Entscheidung trifft.<\/p>\n

\u201eF\u00fcr die Gesundheit und das Wohlbefinden unserer Patienten und ihrer Familien ist es von entscheidender Bedeutung, dass andere wirksame Interventionen identifiziert werden, um wiederkehrende Fr\u00fchgeburten zu verhindern\u201c, sagte die Gruppe in einer Erkl\u00e4rung.<\/p>\n

Medizinische t\u00e4gliche Quelle<\/a><\/p>\n

","protected":false},"excerpt":{"rendered":"

Das durch Injektion eingenommene Medikament ist das Aush\u00e4ngeschild der Herausforderungen, denen sich die FDA stellen muss, um ein Medikament vom Markt zu nehmen, wenn der Hersteller nicht zustimmt.<\/p>","protected":false},"author":2,"featured_media":7667,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"Default","format":"standard","meta":{"fifu_image_url":"https:\/\/urbancare.clinic\/wp-content\/uploads\/2023\/03\/swiss-makers-to-voluntarily-pull-their-unproven-birth-drug-makena-from-market.jpg","fifu_image_alt":"","footnotes":""},"categories":[27],"tags":[],"class_list":["post-7666","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog"],"yoast_head":"\nSwiss Makers To Voluntarily Pull Their Unproven Birth Drug Makena From Market - Urban Care Clinic<\/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:\/\/urbancare.clinic\/de\/schweizer-hersteller-verpflichten-sich-ihr-unbewiesenes-geburtsmedikament-makena-freiwillig-vom-markt-zu-nehmen\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Swiss Makers To Voluntarily Pull Their Unproven Birth Drug Makena From Market - 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