{"id":13059,"date":"2011-11-04T16:29:40","date_gmt":"2011-11-04T20:29:40","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=news&#038;p=13059"},"modified":"2011-11-04T16:29:40","modified_gmt":"2011-11-04T20:29:40","slug":"fda-approves-rivaroxaban-for-stroke-prevention-in-af","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2011\/11\/04\/fda-approves-rivaroxaban-for-stroke-prevention-in-af\/","title":{"rendered":"FDA Approves Rivaroxaban for Stroke Prevention in AF"},"content":{"rendered":"<p>The FDA has approved rivaroxaban (Xarelto, Johnson &amp; Johnson) for stroke reduction in people with non-valvular atrial fibrillation. The label will include a boxed warning that people should not discontinue taking the drug without talking with a healthcare professional. The FDA will also require that patients getting the drug receive a Medication Guide describing the risks and adverse reactions associated with the drug.<\/p>\n<p>The label does not provide firm guidance on the relative merits of rivaroxaban and warfarin in AF patients:<\/p>\n<p style=\"padding-left: 30px;\"><em>There are limited data on the relative effectiveness of XARELTO and warfarin in reducing the risk of stroke and systemic embolism when warfarin therapy is well-controlled.<\/em><\/p>\n<p>Some panelists at the<a href=\"http:\/\/cardiobrief.org\/2011\/09\/08\/live-blog-fda-advisory-panel-on-rivaroxaban-xarelto\/\">\u00a0FDA advisory panel in September<\/a>\u00a0had suggested that rivaroxaban should only be used in patients unable to take warfarin.<\/p>\n<p><a href=\"http:\/\/cardiobrief.files.wordpress.com\/2011\/11\/xarelto-label.pdf\">Click here to download a PDF of the Xarelto label<\/a>.<\/p>\n<p><a href=\"http:\/\/www.fda.gov\/NewsEvents\/Newsroom\/PressAnnouncements\/ucm278646.htm\">Click here to read the FDA announcement.<\/a><\/p>\n<p><a href=\"http:\/\/www.janssenpharmaceuticalsinc.com\/assets\/XareltoPressReleaseNVAF.pdf\">Click here to read the press release from Johnson &amp; Johnson.<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The FDA has approved rivaroxaban (Xarelto, Johnson &amp; Johnson) for stroke reduction in people with non-valvular atrial fibrillation. The label will include a boxed warning that people should not discontinue taking the drug without talking with a healthcare professional. The FDA will also require that patients getting the drug receive a Medication Guide describing the [&hellip;]<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[495,7],"tags":[366,342,1032,990],"class_list":["post-13059","post","type-post","status-publish","format-standard","hentry","category-anticoagulation-2","category-prevention","tag-rivaroxaban","tag-spaf","tag-stroke-prevention-in-af","tag-xarelto"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/13059","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/users\/196"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/comments?post=13059"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/13059\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=13059"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=13059"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=13059"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}