{"id":6020,"date":"2011-01-14T13:12:21","date_gmt":"2011-01-14T18:12:21","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?p=6020"},"modified":"2011-07-19T17:44:38","modified_gmt":"2011-07-19T21:44:38","slug":"fda-warns-about-severe-liver-injury-associated-with-multaq-dronedarone","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2011\/01\/14\/fda-warns-about-severe-liver-injury-associated-with-multaq-dronedarone\/","title":{"rendered":"FDA Warns About Severe Liver Injury Associated with Multaq (Dronedarone)"},"content":{"rendered":"<p>The FDA has released <a href=\"http:\/\/www.fda.gov\/Drugs\/DrugSafety\/ucm240011.htm\">a safety communication<\/a> about severe liver injury associated with Multaq (dronedarone).\u00a0The FDA said that information about the risk of liver injury would be added to the dronedarone label. The drug&#8217;s manufacturer, Sanofi-Aventis, has also sent a letter to healthcare professionals informing them of the warning.<\/p>\n<p>The FDA is recommending that doctors advise their patients &#8220;to contact a\u00a0healthcare professional immediately if they experience signs and symptoms of hepatic injury or toxicity while taking dronedarone.&#8221; In addition, doctors should &#8220;consider\u00a0obtaining periodic hepatic serum enzymes,&#8221; but the FDA acknowledged that there is no evidence whether this step will prevent liver injury.<br \/>\n<img decoding=\"async\" title=\"More...\" src=\"http:\/\/cardiobrief.wordpress.com\/wp-includes\/js\/tinymce\/plugins\/wordpress\/img\/trans.gif\" alt=\"Click here to continue reading, including a comment from Steve Nissen...\" \/><\/p>\n<p>The safety warning is based on several reported cases of liver injury and failure, including two patients who required liver transplants 4.5 and 6 months after starting dronedarone treatment. In both cases no other causes for liver failure were found.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The FDA has released a safety communication about severe liver injury associated with Multaq (dronedarone).\u00a0The FDA said that information about the risk of liver injury would be added to the dronedarone label. The drug&#8217;s manufacturer, Sanofi-Aventis, has also sent a letter to healthcare professionals informing them of the warning. The FDA is recommending that doctors [&hellip;]<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[365,410,196,663,409],"class_list":["post-6020","post","type-post","status-publish","format-standard","hentry","category-electrophysiology","tag-af","tag-dronedarone","tag-fda","tag-liver-toxicity","tag-multaq"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/6020","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=6020"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/6020\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=6020"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=6020"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=6020"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}