{"id":181475,"date":"2026-05-16T17:14:08","date_gmt":"2026-05-16T17:14:08","guid":{"rendered":"https:\/\/www.europesays.com\/ro\/181475\/"},"modified":"2026-05-16T17:14:08","modified_gmt":"2026-05-16T17:14:08","slug":"medicament-autorizat-si-in-romania-investigat-dupa-ce-japonia-a-raportat-20-de-decese","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/ro\/181475\/","title":{"rendered":"Medicament autorizat \u0219i \u00een Rom\u00e2nia, investigat dup\u0103 ce Japonia a raportat 20 de decese"},"content":{"rendered":"<p>Un grup farmaceutic<br \/>\ndin Japonia a transmis un avertisment medicilor privind utilizarea unui<br \/>\nmedicament destinat unor afec\u021biuni autoimune rare, autorizat \u015fi \u00een Rom\u00e2nia,<br \/>\ndup\u0103 ce au fost raportate mai multe decese.<\/p>\n<p>\t\t\t<img decoding=\"async\" src=\"https:\/\/www.europesays.com\/ro\/wp-content\/uploads\/2026\/05\/1778951648_825_index.jpeg\" alt=\"Speciali\u015ftii avertizeaz\u0103 asupra unui medicament cu efecte adverse periculoase. FOTO: Shutterstock\" width=\"1400\" height=\"750\" loading=\"eager\" fetchpriority=\"high\" class=\"svelte-h45upf\"\/><\/p>\n<p>Speciali\u015ftii avertizeaz\u0103 asupra unui medicament cu efecte adverse periculoase. FOTO: Shutterstock<\/p>\n<p>publicitate&#8221;); background-position: center center; background-repeat: no-repeat;&#8221;&gt;<\/p>\n<p>Un grup farmaceutic<br \/>\njaponez le cere medicilor s\u0103 nu mai prescrie un medicament utilizat \u00een tratarea<br \/>\nunor <a href=\"https:\/\/adevarul.ro\/stil-de-viata\/oameni-fericiti-medici-buni\/testul-genetic-care-poate-indica-riscul-unor-boli-2524138.html\" target=\"_blank\" rel=\"nofollow noopener\">boli autoimune<\/a> rare, dup\u0103 apari\u021bia a 20 de decese asociate tratamentului.<br \/>\nSubstan\u021ba este autorizat\u0103 \u0219i \u00een Uniunea European\u0103, inclusiv \u00een Rom\u00e2nia.<\/p>\n<p>Compania Kissei<br \/>\nPharmaceutical, de\u021bin\u0103torul licen\u021bei de comercializare \u00een Japonia pentru<br \/>\nmedicamentul Tavneos, a transmis vineri, 15 mai, un mesaj c\u0103tre personalul<br \/>\nmedical \u00een care precizeaz\u0103 c\u0103, de la introducerea sa pe pia\u021b\u0103 \u00een iunie 2022, au<br \/>\nfost \u00eenregistrate 20 de cazuri mortale. <\/p>\n<p>\u00cen acest context,<br \/>\nproduc\u0103torul atrage aten\u021bia asupra unui posibil risc de afectare sever\u0103 a<br \/>\nfunc\u021biei hepatice. \u00cen recomandarea transmis\u0103 medicilor, compania solicit\u0103<br \/>\noprirea ini\u021bierii tratamentului la pacien\u021bi noi \u0219i reevaluarea continu\u0103rii<br \/>\nterapiei \u00een cazul celor afla\u021bi deja sub tratament, potrivit <a href=\"https:\/\/pharma.economictimes.indiatimes.com\/amp\/news\/pharma-industry\/amgens-rare-disease-drug-linked-to-deaths-liver-injuries-in-japan-kissei-reports\/131130047?utm_source=chatgpt.com\" target=\"_blank\" rel=\"nofollow noopener\">indiatimes.<\/a><\/p>\n<p>Tavneos este<br \/>\nindicat pentru tratamentul vasculitei asociate ANCA, un grup rar de boli<br \/>\nautoimune care provoac\u0103 inflama\u021bia vaselor mici \u0219i medii de s\u00e2nge \u0219i pot afecta<br \/>\norgane precum rinichii, pl\u0103m\u00e2nii sau sistemul nervos.<\/p>\n<p>Medicamentul,<br \/>\ndezvoltat de compania american\u0103 de biotehnologie Amgen, a fost administrat,<br \/>\npotrivit datelor furnizate de produc\u0103tor, unui num\u0103r de aproximativ 8.500 de<br \/>\npacien\u021bi \u00een Japonia de la momentul lans\u0103rii.<\/p>\n<p>Potrivit Agen\u021biei<br \/>\nEuropene pentru Medicamente <a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/tavneos?utm\" target=\"_blank\" rel=\"nofollow noopener\">(EMA), <\/a>substan\u021ba activ\u0103, avacopan, este autorizat\u0103<br \/>\nla nivelul Uniunii Europene din ianuarie 2022, ceea ce \u00eenseamn\u0103 c\u0103 poate fi<br \/>\nprescris\u0103 \u0219i \u00een Rom\u00e2nia.<\/p>\n<p>Potrivit unui<br \/>\ncomunicat al companiei americane Amgen, \u00een SUA nu au fost raportate decese<br \/>\nasociate leziunilor hepatice severe \u00een r\u00e2ndul celor peste 8.000 de pacien\u021bi<br \/>\ntrata\u021bi. <\/p>\n<p>Totu\u0219i, \u00een aprilie,<br \/>\no structur\u0103 din cadrul Administra\u021biei pentru Alimente \u0219i Medicamente (FDA) a<br \/>\npropus retragerea autoriza\u021biei de punere pe pia\u021b\u0103, invoc\u00e2nd inclusiv suspiciuni<br \/>\nlegate de integritatea unor date clinice.<\/p>\n<p>publicitate&#8221;); background-position: center center; background-repeat: no-repeat;&#8221;&gt;<\/p>\n<p>\u0218i la nivel<br \/>\neuropean, Agen\u021bia European\u0103 pentru Medicamente a anun\u021bat la \u00eenceputul anului c\u0103<br \/>\nanalizeaz\u0103 dosarul, pe fondul unor semne de \u00eentrebare privind calitatea \u0219i<br \/>\ntransparen\u021ba datelor utilizate \u00een evaluare.<\/p>\n","protected":false},"excerpt":{"rendered":"Un grup farmaceutic din Japonia a transmis un avertisment medicilor privind utilizarea unui medicament destinat unor afec\u021biuni autoimune&hellip;\n","protected":false},"author":2,"featured_media":181476,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_share_on_mastodon":"0"},"categories":[12],"tags":[51895,45432,32,33,31,36,37,27,74,34,35,51894,25,41,40,38,39,26,28,29,30,51896,71,72,73],"class_list":["post-181475","post","type-post","status-publish","format-standard","has-post-thumbnail","category-international","tag-avertisment-medici","tag-boli-autoimune","tag-breaking-news","tag-breakingnews","tag-cele-mai-populare-subiecte","tag-featured-news","tag-featurednews","tag-headlines","tag-international","tag-latest-news","tag-latestnews","tag-medicament-periculos","tag-news","tag-ro","tag-romana","tag-romania","tag-romanian","tag-stiri","tag-titluri","tag-top-stories","tag-topstories","tag-tratament-boli-autoimune","tag-world","tag-world-news","tag-worldnews"],"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@ro\/116585383017578343","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/ro\/wp-json\/wp\/v2\/posts\/181475","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/ro\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/ro\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ro\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ro\/wp-json\/wp\/v2\/comments?post=181475"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/ro\/wp-json\/wp\/v2\/posts\/181475\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ro\/wp-json\/wp\/v2\/media\/181476"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/ro\/wp-json\/wp\/v2\/media?parent=181475"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/ro\/wp-json\/wp\/v2\/categories?post=181475"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/ro\/wp-json\/wp\/v2\/tags?post=181475"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}