{"id":10390,"date":"2011-07-20T18:38:53","date_gmt":"2011-07-20T22:38:53","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=news&#038;p=10390"},"modified":"2011-07-25T14:52:20","modified_gmt":"2011-07-25T18:52:20","slug":"ticagrelor-brilinta-gains-fda-approval","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2011\/07\/20\/ticagrelor-brilinta-gains-fda-approval\/","title":{"rendered":"Ticagrelor (Brilinta) Gains FDA Approval"},"content":{"rendered":"<p>The FDA has approved ticagrelor (Brilinta, AstraZeneca). In <a href=\"http:\/\/www.fda.gov\/NewsEvents\/Newsroom\/PressAnnouncements\/ucm263964.htm\">a press release<\/a>, the FDA said that the drug was approved to reduce cardiovascular death and MI in patients with acute coronary syndromes.<\/p>\n<p>The drug&#8217;s label will include a boxed warning about bleeding risks, and &#8212; of considerable significance in light of the enormous amount of discussion about the topic &#8212; the label will state that aspirin doses greater than 100 mg\/day decrease the drug&#8217;s efficacy. Said the FDA&#8217;s Norman Stockbridge, the director of the Division of Cardiovascular and Renal Products in the FDA&#8217;s Center for Drug Evaluation and Research:<\/p>\n<blockquote><p>\u201cIn clinical trials, Brilinta was more effective than Plavix in preventing heart attacks and death, but that advantage was seen with aspirin maintenance doses of 75 to 100 milligrams once daily.&#8221;<\/p><\/blockquote>\n<p>The FDA said that the drug was approved with a Risk Evaluation and Mitigation Strategy, which will require the company to educate physicians about the risk of using higher doses of aspirin.<\/p>\n<p><a href=\"http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2011\/022433s000lbl.pdf\">Click here to download a PDF of the Brilinta label.<\/a><\/p>\nSorry, there are no polls available at the moment.\n","protected":false},"excerpt":{"rendered":"<p>With the FDA approval, will you be using this drug in your practice?<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-10390","post","type-post","status-publish","format-standard","hentry"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/10390","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=10390"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/10390\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=10390"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=10390"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=10390"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}