{"id":24050,"date":"2023-03-08T01:02:26","date_gmt":"2023-03-08T00:02:26","guid":{"rendered":"http:\/\/www.infokuryr.cz\/n\/?p=24050"},"modified":"2023-03-07T14:42:10","modified_gmt":"2023-03-07T13:42:10","slug":"schvaleni-zamitnuto-lek-covid-se-jiz-nesmi-podavat","status":"publish","type":"post","link":"https:\/\/www.infokuryr.cz\/n\/2023\/03\/08\/schvaleni-zamitnuto-lek-covid-se-jiz-nesmi-podavat\/","title":{"rendered":"Schv\u00e1len\u00ed zam\u00edtnuto: L\u00e9k Covid se ji\u017e nesm\u00ed pod\u00e1vat"},"content":{"rendered":"<div id=\"fb-root\"><\/div>\n<p><strong>L\u00e9k Lagevrio s \u00fa\u010dinnou l\u00e1tkou molnupiravir ji\u017e nelze p\u0159edepisovat: EMA zam\u00edtla \u017e\u00e1dost o schv\u00e1len\u00ed p\u0159\u00edpravku k l\u00e9\u010db\u011b Covid-19.\u00a0Klinick\u00fd p\u0159\u00ednos pro pacienty nebylo mo\u017en\u00e9 ur\u010dit.\u00a0Pikantn\u00ed: Vl\u00e1dy jako n\u011bmeck\u00e1 a rakousk\u00e1 ji\u017e opat\u0159ily l\u00e9k bez schv\u00e1len\u00ed na za\u010d\u00e1tku roku 2022 a uvedly jej na trh navzdory varov\u00e1n\u00ed p\u0159ed nebezpe\u010dn\u00fdmi vedlej\u0161\u00edmi \u00fa\u010dinky.<\/strong><\/p>\n<p>Dne 24. \u00fanora\u00a0<a href=\"https:\/\/www.apotheke-adhoc.de\/nachrichten\/detail\/politik\/lagevrio-nicht-mehr-verkehrsfaehig\/\" target=\"_blank\" rel=\"noreferrer noopener\">EMA zam\u00edtla<\/a>\u00a0\u017e\u00e1dost v\u00fdrobce MSD \/ Merck o schv\u00e1len\u00ed Lagevrio.\u00a0Farmaceutick\u00fd gigant nedok\u00e1zal prok\u00e1zat, \u017ee l\u00e9k sni\u017euje riziko hospitalizac\u00ed a \u00famrt\u00ed.\u00a0Doba nemoci tak\u00e9 nebyla zkr\u00e1cena.\u00a0Podle kompeten\u010dn\u00edho v\u00fdboru EMA nebylo mo\u017en\u00e9 v EU identifikovat konkr\u00e9tn\u00ed skupinu pacient\u016f, u kter\u00fdch lze o\u010dek\u00e1vat klinicky v\u00fdznamn\u00fd p\u0159\u00ednos p\u0159\u00edpravku Lagevrio.\u00a0<strong>Pom\u011br p\u0159\u00ednos\u016f a rizik p\u0159i l\u00e9\u010db\u011b Covid-19 proto nebylo mo\u017en\u00e9 ur\u010dit.<\/strong><\/p>\n<p>V n\u011bkolika zem\u00edch EU se v\u0161ak vl\u00e1dy spol\u00e9haly na prvn\u00ed pr\u016fb\u011b\u017en\u00e9 v\u00fdsledky studi\u00ed v\u00fdrobc\u016f, obstaraly l\u00e9k centr\u00e1ln\u011b a daly ho pacient\u016fm ohro\u017een\u00fdm Covidem bez schv\u00e1len\u00ed.\u00a0<strong>\u201eSpolkov\u00e9 ministerstvo zdravotnictv\u00ed (BMG) od za\u010d\u00e1tku roku 2022 uv\u00e1d\u00ed na trh centr\u00e1ln\u011b po\u0159izovan\u00fd l\u00e9k Lagevrio na z\u00e1klad\u011b MedBVSV bez schv\u00e1len\u00ed.<\/strong>Z\u00e1kladem pro to bylo posouzen\u00ed BfArM o o\u010dek\u00e1van\u00e9m pozitivn\u00edm pom\u011bru p\u0159\u00ednos\u016f a rizik.\u00a0Mezit\u00edm prob\u00edhal centr\u00e1ln\u00ed schvalovac\u00ed proces,\u201c vysv\u011btlil v dopise N\u011bmeck\u00fd spolkov\u00fd institut pro l\u00e9\u010diva a zdravotnick\u00e9 prost\u0159edky (BfArM).\u00a0Nyn\u00ed, kdy\u017e je postup dokon\u010den, dal\u0161\u00ed v\u00fddej l\u00e9ku je p\u0159eru\u0161en.\u00a0Zbo\u017e\u00ed, kter\u00e9 ji\u017e bylo dod\u00e1no farmaceutick\u00fdm velkoobchod\u016fm a l\u00e9k\u00e1rn\u00e1m, ji\u017e nelze odevzdat.<\/p>\n<p>Rakousk\u00e9 spolkov\u00e9 ministerstvo pro soci\u00e1ln\u00ed v\u011bci, zdrav\u00ed, p\u00e9\u010di a ochranu spot\u0159ebitele jeho pou\u017eit\u00ed zd\u016fvod\u0148uje v tiskov\u00e9\u00a0<a href=\"https:\/\/www.ots.at\/presseaussendung\/OTS_20230306_OTS0035\/gesundheitsministerium-verabreichung-von-covid-19-medikament-lagevrio-auch-in-oesterreich-eingestellt\" target=\"_blank\" rel=\"noreferrer noopener\">zpr\u00e1v\u011b<\/a>\u00a0takto: \u201eLagevrio bylo pou\u017e\u00edv\u00e1no v mnoha zem\u00edch EU k ochran\u011b lid\u00ed p\u0159ed v\u00e1\u017en\u00fdmi nemocemi.\u00a0<strong>Klinick\u00e9 studie zpo\u010d\u00e1tku uk\u00e1zaly, \u017ee p\u0159\u00edpravek Lagevrio je \u00fa\u010dinn\u00fd.\u00a0Ministerstvo zdravotnictv\u00ed se proto rozhodlo l\u00e9k zakoupit a pou\u017e\u00edt v r\u00e1mci programu \u201ecompassionate use\u201c.<\/strong>Uv\u00e1d\u00ed se, \u017ee bylo pod\u00e1no kolem 25 000 balen\u00ed Lagevrio;\u00a0dal\u0161\u00edch 100 000 balen\u00ed je st\u00e1le skladem.\u00a0V individu\u00e1ln\u00edch p\u0159\u00edpadech mohou o\u0161et\u0159uj\u00edc\u00ed l\u00e9ka\u0159i i nad\u00e1le l\u00e9k u\u017e\u00edvat \u201epo individu\u00e1ln\u00edm posouzen\u00ed p\u0159\u00ednosu a rizika v r\u00e1mci tzv. pokusu o uzdraven\u00ed (tzv. \u201epacient use\u201c)\u201c.\u00a0Vzhledem k tomu, \u017ee ani EMA, kter\u00e1 je jinak ze schv\u00e1len\u00ed tak nad\u0161en\u00e1, nevid\u00ed v p\u0159\u00edprav\u011b \u017e\u00e1dn\u00fd p\u0159\u00ednos, lze to pravd\u011bpodobn\u011b pova\u017eovat za sporn\u00e9.\u00a0<strong><a href=\"https:\/\/www.echo24.de\/welt\/molnupiravir-corona-medikament-gefahren-experte-fehlbildungen-nebenwirkungen-lagevrio-zr-91251276.html\" target=\"_blank\" rel=\"noreferrer noopener\">Ji\u017e na za\u010d\u00e1tku roku 2022 odborn\u00edci varovali<\/a><\/strong><strong> p\u0159ed v\u00fdznamn\u00fdmi riziky a vedlej\u0161\u00edmi \u00fa\u010dinky u\u017e\u00edv\u00e1n\u00ed molnupiraviru a spojovali jej s genetick\u00fdmi mutacemi a malformacemi.<\/strong><\/p>\n<p>P\u0159\u00edpad Lagevrio znovu ukazuje, jak se klamn\u00e9 vl\u00e1dy b\u011bhem \u201epandemie\u201c z\u00e1sobily pochybn\u00fdmi drogami na \u00fakor da\u0148ov\u00fdch poplatn\u00edk\u016f, ani\u017e by za\u010daly zpochyb\u0148ovat jejich rizika a p\u0159\u00ednosy.\u00a0Z\u00e1v\u011bry, kter\u00e9 EMA nyn\u00ed vyvodila ohledn\u011b Lagevrio, by se daly up\u0159\u00edmn\u011b vyvodit tak\u00e9 s ohledem na vakc\u00edny Covid.\u00a0Nicm\u00e9n\u011b: V\u0161echny zjevn\u011b kritick\u00e9 aspekty schvalovac\u00edch studi\u00ed v\u00fdrobc\u016f zde EMA d\u016fsledn\u011b ignorovala.\u00a0Po\u017eadavky na spole\u010dnost Pfizer and Co., aby kone\u010dn\u011b zve\u0159ejnila v\u0161echna data, jsou st\u00e1le marn\u00e9.<\/p>\n<p><a href=\"https:\/\/report24.news\/zulassung-abgelehnt-covid-medikament-darf-nicht-mehr-verabreicht-werden\/\">Report24<\/a><\/p>\n<p>&nbsp;<\/p>\n<p><img decoding=\"async\" loading=\"lazy\" class=\"wp-image-19187 aligncenter\" src=\"http:\/\/www.infokuryr.cz\/n\/wp-content\/uploads\/2022\/12\/1-PRO-300x36.jpg\" alt=\"\" width=\"1142\" height=\"137\" srcset=\"https:\/\/www.infokuryr.cz\/n\/wp-content\/uploads\/2022\/12\/1-PRO-300x36.jpg 300w, https:\/\/www.infokuryr.cz\/n\/wp-content\/uploads\/2022\/12\/1-PRO.jpg 699w\" sizes=\"(max-width: 1142px) 100vw, 1142px\" \/><\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p><img decoding=\"async\" loading=\"lazy\" class=\"wp-image-22607 aligncenter\" src=\"http:\/\/www.infokuryr.cz\/n\/wp-content\/uploads\/2023\/02\/cesko_proti_bide-239x300.png\" alt=\"\" width=\"782\" height=\"982\" srcset=\"https:\/\/www.infokuryr.cz\/n\/wp-content\/uploads\/2023\/02\/cesko_proti_bide-239x300.png 239w, https:\/\/www.infokuryr.cz\/n\/wp-content\/uploads\/2023\/02\/cesko_proti_bide-816x1024.png 816w, https:\/\/www.infokuryr.cz\/n\/wp-content\/uploads\/2023\/02\/cesko_proti_bide-768x964.png 768w, https:\/\/www.infokuryr.cz\/n\/wp-content\/uploads\/2023\/02\/cesko_proti_bide.png 846w\" sizes=\"(max-width: 782px) 100vw, 782px\" \/><\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>L\u00e9k Lagevrio s \u00fa\u010dinnou l\u00e1tkou molnupiravir ji\u017e nelze p\u0159edepisovat: EMA zam\u00edtla \u017e\u00e1dost o schv\u00e1len\u00ed p\u0159\u00edpravku&#8230;<\/p>\n","protected":false},"author":2,"featured_media":24051,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[7],"tags":[23,132,1453,720],"_links":{"self":[{"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/posts\/24050"}],"collection":[{"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/comments?post=24050"}],"version-history":[{"count":0,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/posts\/24050\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/media\/24051"}],"wp:attachment":[{"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/media?parent=24050"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/categories?post=24050"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.infokuryr.cz\/n\/wp-json\/wp\/v2\/tags?post=24050"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}