{"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":"les-fabricants-suisses-retirent-volontairement-du-marche-leur-medicament-de-naissance-non-prouve-makena","status":"publish","type":"post","link":"https:\/\/urbancare.clinic\/fr\/les-fabricants-suisses-retirent-volontairement-du-marche-leur-medicament-de-naissance-non-prouve-makena\/","title":{"rendered":"Les fabricants suisses retireront volontairement du march\u00e9 leur m\u00e9dicament de naissance non prouv\u00e9 Makena"},"content":{"rendered":"
<\/div>\n

Le fabricant d'un m\u00e9dicament non \u00e9prouv\u00e9, Makena, a d\u00e9clar\u00e9 qu'il retirerait volontairement le produit des \u00c9tats-Unis. Fabriqu\u00e9 par Covis Pharma, bas\u00e9e en Suisse, le m\u00e9dicament est destin\u00e9 \u00e0 pr\u00e9venir les naissances pr\u00e9matur\u00e9es. <\/p>\n

La soci\u00e9t\u00e9 a fait cette annonce mardi, selon Actualit\u00e9s ABC<\/a>. La d\u00e9cision de supprimer le m\u00e9dicament intervient apr\u00e8s pr\u00e8s de quatre ans, puisque Makena n'a pu d\u00e9montrer aucun b\u00e9n\u00e9fice pour aider les m\u00e8res \u00e0 mener leur grossesse \u00e0 terme.<\/p>\n

Makena est une version synth\u00e9tique de l\u2019hormone progest\u00e9rone, essentielle au maintien d\u2019une grossesse. C\u2019est \u00e9galement le seul m\u00e9dicament approuv\u00e9 par la FDA pour r\u00e9duire le risque d\u2019accouchement pr\u00e9matur\u00e9.<\/p>\n

Pris par injection, le m\u00e9dicament est l\u2019exemple type des d\u00e9fis auxquels la FDA doit faire face pour retirer un m\u00e9dicament lorsque le fabricant n\u2019y consent pas.<\/p>\n

<\/div>\n

Le calendrier du retrait du m\u00e9dicament du march\u00e9 reste obscur. Covis a d\u00e9clar\u00e9 dans son communiqu\u00e9 que les r\u00e9gulateurs de la FDA avaient rejet\u00e9 sa proposition de r\u00e9duire l'utilisation du m\u00e9dicament sur plusieurs mois.<\/p>\n

La soci\u00e9t\u00e9 a d\u00e9clar\u00e9 que cette prolongation permettrait aux femmes sous ordonnance de terminer leur traitement, qui commence apr\u00e8s 16 semaines de grossesse.<\/p>\n

Cependant, dans un dossier distinct mercredi, les r\u00e9gulateurs pharmaceutiques de la FDA ont fortement recommand\u00e9 de rendre le retrait \u00ab imm\u00e9diatement effectif \u00bb, selon le m\u00e9dia. L\u2019agence a ajout\u00e9 qu\u2019il n\u2019y avait aucun \u00ab pr\u00e9judice raisonnable li\u00e9 \u00e0 l\u2019arr\u00eat de Makena, tel que des signes ou des sympt\u00f4mes de sevrage \u00bb.<\/p>\n

Tout a commenc\u00e9 en octobre lors d'une r\u00e9union publique lorsque des conseillers ext\u00e9rieurs ont conclu que Makena n'\u00e9tait pas en mesure de prouver son efficacit\u00e9 et que son approbation devait \u00eatre r\u00e9voqu\u00e9e. Le panel n\u2019a pas \u00e9t\u00e9 convaincu, malgr\u00e9 les heures de pr\u00e9sentations et de d\u00e9bats propos\u00e9s par Covis essayant de prouver que le m\u00e9dicament pouvait \u00eatre utile \u00e0 un sous-groupe de femmes.<\/p>\n

Il convient de noter que de telles audiences sont tr\u00e8s rares et n\u2019ont lieu qu\u2019apr\u00e8s qu\u2019un fabricant de m\u00e9dicaments s\u2019est oppos\u00e9 aux demandes initiales de la FDA visant \u00e0 retirer son m\u00e9dicament.<\/p>\n

"Bien que nous maintenions le profil b\u00e9n\u00e9fice-risque favorable de Makena, y compris son efficacit\u00e9 chez les femmes pr\u00e9sentant le risque le plus \u00e9lev\u00e9 d'accouchement pr\u00e9matur\u00e9, nous cherchons \u00e0 retirer volontairement le produit et \u00e0 travailler avec la FDA pour effectuer une cessation ordonn\u00e9e", a d\u00e9clar\u00e9 Raghav Chari, Le directeur de l'information de Covis, dans un communiqu\u00e9, Nouvelles de la SCB<\/a> signal\u00e9.<\/p>\n

Le fabricant de m\u00e9dicaments a d\u00e9clar\u00e9 qu\u2019il \u00ab restait pr\u00eat \u00e0 travailler en coop\u00e9ration avec l\u2019agence \u00bb, malgr\u00e9 une impasse sur le calendrier.<\/p>\n

Makena a obtenu une approbation acc\u00e9l\u00e9r\u00e9e en 2011 par la FDA. La d\u00e9cision reposait sur une petite \u00e9tude men\u00e9e aupr\u00e8s de femmes ayant des ant\u00e9c\u00e9dents d\u2019accouchements pr\u00e9coces. L'approbation a \u00e9t\u00e9 donn\u00e9e \u00e0 la condition qu'une \u00e9tude de suivi plus large soit men\u00e9e pour confirmer l'efficacit\u00e9 du m\u00e9dicament.<\/p>\n

En 2019, une \u00e9tude internationale portant sur 1\u00a0700 patients a r\u00e9v\u00e9l\u00e9 que m\u00e9dicament<\/a> ni r\u00e9duit les naissances pr\u00e9matur\u00e9es ni abouti \u00e0 des r\u00e9sultats plus sains pour les b\u00e9b\u00e9s.<\/p>\n

Malgr\u00e9 les r\u00e9sultats, les sp\u00e9cialistes de la reproduction, notamment les membres du Coll\u00e8ge am\u00e9ricain des obst\u00e9triciens et gyn\u00e9cologues, sont favorables au maintien sur le march\u00e9 du m\u00e9dicament inject\u00e9 chaque semaine jusqu'\u00e0 ce que des recherches plus approfondies soient men\u00e9es.<\/p>\n

Le groupe a d\u00e9clar\u00e9 que ses lignes directrices seront efficaces jusqu'\u00e0 ce que la FDA prenne une d\u00e9cision finale.<\/p>\n

"Il est essentiel que d'autres interventions efficaces soient identifi\u00e9es pour pr\u00e9venir les naissances pr\u00e9matur\u00e9es r\u00e9currentes pour la sant\u00e9 et le bien-\u00eatre de nos patients et de leurs familles", a d\u00e9clar\u00e9 le groupe dans un communiqu\u00e9.<\/p>\n

Source quotidienne m\u00e9dicale<\/a><\/p>\n

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

Pris par injection, le m\u00e9dicament est l\u2019exemple type des d\u00e9fis auxquels la FDA doit faire face pour retirer un m\u00e9dicament lorsque le fabricant n\u2019y consent pas.<\/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\/fr\/les-fabricants-suisses-retirent-volontairement-du-marche-leur-medicament-de-naissance-non-prouve-makena\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\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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