{"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":"i-produttori-svizzeri-ritirano-volontariamente-dal-mercato-la-loro-marca-di-farmaci-naturali-non-provata","status":"publish","type":"post","link":"https:\/\/urbancare.clinic\/it\/i-produttori-svizzeri-ritirano-volontariamente-dal-mercato-la-loro-marca-di-farmaci-naturali-non-provata\/","title":{"rendered":"I produttori svizzeri ritireranno volontariamente dal mercato il loro farmaco contraccettivo non provato Makena"},"content":{"rendered":"<div><img decoding=\"async\" src=\"https:\/\/urbancare.clinic\/wp-content\/uploads\/2023\/03\/swiss-makers-to-voluntarily-pull-their-unproven-birth-drug-makena-from-market.jpg\" class=\"ff-og-image-inserted\" style=\"display:none\"><\/div>\n<p>Il produttore di un farmaco non testato, Makena, ha dichiarato che ritirer\u00e0 volontariamente il prodotto dagli Stati Uniti. Prodotto da Covis Pharma, con sede in Svizzera, il farmaco \u00e8 destinato a prevenire le nascite premature.&nbsp;<\/p>\n<p>La societ\u00e0 ha fatto l&#039;annuncio marted\u00ec, secondo <a href=\"https:\/\/abcnews.go.com\/Health\/wireStory\/maker-unproven-birth-drug-makena-pull-us-market-97707396\" rel=\"nofollow noopener\" target=\"_blank\">Notizie dell&#039;ABC<\/a>. La decisione di eliminare il farmaco arriva dopo quasi quattro anni da quando Makena non ha dimostrato alcun beneficio nell&#039;aiutare le madri a portare a termine la gravidanza.<\/p>\n<p>Makena \u00e8 una versione sintetica dell&#039;ormone progesterone, vitale per il mantenimento della gravidanza. \u00c8 anche l\u2019unico farmaco con l\u2019approvazione della FDA per ridurre il rischio di parto prematuro.<\/p>\n<p>Assunto tramite iniezione, il farmaco \u00e8 l\u2019emblema delle sfide che la FDA deve affrontare per ritirare un farmaco quando il produttore non \u00e8 consenziente.<\/p>\n<div id=\"dfp-ad-oop2\" class=\"dfp-tag-wrapper\"> <\/div>\n<p>La tempistica per il ritiro del farmaco dal mercato rimane oscura. Covis ha affermato nel suo comunicato che i regolatori della FDA hanno respinto la sua proposta di ridurre l&#039;uso del farmaco per diversi mesi.<\/p>\n<p>La societ\u00e0 ha affermato che l\u2019estensione consentirebbe alle donne che assumono la prescrizione di terminare il ciclo di trattamento, che inizia dopo 16 settimane di gravidanza.<\/p>\n<p>Tuttavia, in un documento separato mercoled\u00ec, gli enti regolatori dei farmaci della FDA hanno fortemente raccomandato di rendere il ritiro \u201cimmediatamente efficace\u201d, secondo il quotidiano. L\u2019agenzia ha aggiunto che non vi \u00e8 alcun ragionevole \u201cdanno derivante dalla sospensione di Makena, come segni o sintomi di astinenza\u201d.<\/p>\n<p>Tutto \u00e8 iniziato in ottobre in un incontro pubblico quando i consulenti esterni hanno concluso che Makena non era in grado di dimostrare la sua efficacia e la sua approvazione doveva essere revocata. Il gruppo di esperti non era convinto, nonostante le ore di presentazioni e dibattiti portati avanti da Covis nel tentativo di dimostrare che il farmaco potrebbe essere utile per un sottogruppo di donne.<\/p>\n<p>Va notato che udienze come queste sono molto rare e hanno luogo solo dopo che un produttore farmaceutico si \u00e8 opposto alle richieste iniziali della FDA di rimuovere il suo farmaco.<\/p>\n<p>&quot;Mentre sosteniamo il favorevole profilo rischio-beneficio di Makena, inclusa la sua efficacia nelle donne a pi\u00f9 alto rischio di parto pretermine, stiamo cercando di ritirare volontariamente il prodotto e di collaborare con la FDA per effettuare una liquidazione ordinata&quot;, ha affermato Raghav Chari, Il chief information officer di Covis, in un comunicato, <a href=\"https:\/\/www.cbsnews.com\/news\/premature-birth-drug-makena-covid-pharrma-fda-us\/\" rel=\"nofollow noopener\" target=\"_blank\">Notizie della CBS<\/a> segnalato.<\/p>\n<p>L\u2019azienda farmaceutica ha affermato che \u201crimane pronta a lavorare in cooperazione con l\u2019agenzia\u201d, nonostante un\u2019impasse sui tempi.<\/p>\n<p>Makena ha ottenuto l&#039;approvazione accelerata nel 2011 dalla FDA. La decisione si basava su un piccolo studio condotto su donne che avevano una storia di parti precoci. L&#039;approvazione \u00e8 stata data a condizione che venisse condotto uno studio di follow-up pi\u00f9 ampio per confermare l&#039;efficacia del farmaco.<\/p>\n<p>Nel 2019, uno studio internazionale che ha coinvolto 1.700 pazienti ha scoperto che <a href=\"https:\/\/www.medicaldaily.com\/weight-loss-drugs-ozempic-may-increase-risk-intestinal-obstruction-researchers-468371\">farmaco<\/a> n\u00e9 hanno ridotto le nascite premature n\u00e9 hanno portato a risultati pi\u00f9 sani per i bambini.<\/p>\n<p>Nonostante i risultati, gli specialisti della riproduzione, compresi i membri dell\u2019American College of Obstetricians and Gynecologists, sono favorevoli a mantenere il farmaco iniettato settimanalmente sul mercato fino a quando non verranno condotte ulteriori ricerche.<\/p>\n<p>Il gruppo ha dichiarato che le sue linee guida saranno efficaci finch\u00e9 la FDA non prender\u00e0 una decisione definitiva.<\/p>\n<p>&quot;\u00c8 fondamentale che vengano identificati altri interventi efficaci per prevenire le recidive di nascite premature per la salute e il benessere dei nostri pazienti e delle loro famiglie&quot;, ha affermato il gruppo in una nota.<\/p>\n<p><a href=\"https:\/\/www.medicaldaily.com\/swiss-makers-voluntarily-pull-their-unproven-birth-drug-makena-market-468393?utm_source=Public&#038;utm_medium=Feed&#038;utm_campaign=Distribution\">Fonte quotidiana medica<\/a><\/p>\n<p>","protected":false},"excerpt":{"rendered":"<p>Assunto tramite iniezione, il farmaco \u00e8 l\u2019emblema delle sfide che la FDA deve affrontare per ritirare un farmaco quando il produttore non \u00e8 consenziente.<\/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":"<!-- This site is optimized with the Yoast SEO plugin v26.6 - 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