{"id":3490,"date":"2010-09-23T13:33:56","date_gmt":"2010-09-23T17:33:56","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?p=3490"},"modified":"2011-07-19T17:44:48","modified_gmt":"2011-07-19T21:44:48","slug":"fda-and-ema-split-on-fate-of-avandia","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2010\/09\/23\/fda-and-ema-split-on-fate-of-avandia\/","title":{"rendered":"FDA and EMA Split on Fate of Avandia"},"content":{"rendered":"<p>The FDA and the European Medicines Agency announced separate and divergent decisions on the fate of rosiglitazone (Avandia) today.<\/p>\n<p>On the one hand, <a href=\"http:\/\/www.fda.gov\/NewsEvents\/Newsroom\/PressAnnouncements\/ucm226975.htm\">the FDA announced<\/a> that it would allow rosiglitazone to remain on the market, though only with severe restrictions on its use. Additionally, the FDA said it would require the drug&#8217;s manufacturer &#8220;to convene an independent group of scientists&#8221; to re-adjudicate the controversial RECORD trial. The FDA also placed the TIDE trial on &#8220;full clinical hold&#8221;. (<a href=\"http:\/\/www.fda.gov\/Drugs\/DrugSafety\/PostmarketDrugSafetyInformationforPatientsandProviders\/ucm226956.htm\">Click here for more FDA documents.<\/a>)<\/p>\n<p>On the other hand, <a href=\"http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/news_and_events\/news\/2010\/09\/news_detail_001119.jsp&amp;murl=menus\/news_and_events\/news_and_events.jsp&amp;mid=WC0b01ac058004d5c1\">the European Medicines Agency announced<\/a> it was recommending suspension of rosiglitazone and said the drug will no longer be available in Europe &#8220;within the next few months.&#8221;<\/p>\n<p>Several hours after the announcements, the\u00a0<em>New England Journal of Medicine<\/em> published\u00a0<a href=\"http:\/\/healthpolicyandreform.nejm.org\/?p=12698\">a perspective on rosiglitazone<\/a> by the FDA&#8217;s Janet Woodcock, Joshua Sharfstein, and Margaret Hamburg.<\/p>\n<p><a><\/a><\/p>\n<p><a><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The FDA and the European Medicines Agency announced separate and divergent decisions on the fate of rosiglitazone (Avandia) today. On the one hand, the FDA announced that it would allow rosiglitazone to remain on the market, though only with severe restrictions on its use. Additionally, the FDA said it would require the drug&#8217;s manufacturer &#8220;to [&hellip;]<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1,7],"tags":[199,430,196,205],"class_list":["post-3490","post","type-post","status-publish","format-standard","hentry","category-general","category-prevention","tag-avandia","tag-ema","tag-fda","tag-rosiglitazone"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/3490","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=3490"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/3490\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=3490"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=3490"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=3490"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}