{"id":7841,"date":"2011-04-14T13:03:24","date_gmt":"2011-04-14T17:03:24","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?p=7841"},"modified":"2011-07-19T17:44:27","modified_gmt":"2011-07-19T21:44:27","slug":"fda-officials-offer-explanation-for-absence-of-low-dose-dabigatran","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2011\/04\/14\/fda-officials-offer-explanation-for-absence-of-low-dose-dabigatran\/","title":{"rendered":"FDA Officials Offer Explanation for Absence of Low-Dose Dabigatran"},"content":{"rendered":"<p>Following the approval last October of dabigatran, some observers criticized the FDA&#8217;s decision not to approve the lower 110 mg dose of  the drug in addition to the higher 150 mg dose. Now, <a href=\"http:\/\/healthpolicyandreform.nejm.org\/?p=14213&amp;query=home\">in  a perspective in the <em>New England Journal of Medicine<\/em><\/a>, 3  FDA officials\u00a0\u2014 B. Nhi Beasley, Ellis Unger, and Robert Temple\u00a0\u2014 explain  that their decision &#8220;was based on our inability to  identify any  subgroup in which use of  the  lower dose would not represent  a  substantial disadvantage.&#8221;<\/p>\n<p>The FDA officials acknowledge that there were several good reasons  for approving the lower dose, including the finding of safety and  efficacy and the ability to individualize treatment. However, the FDA  review team was unable to identify a patient population in which the  lower dose might be superior to the higher dose, including older  patients, patients with renal function, and patients with previous  bleeding episodes.<\/p>\n<p>The authors also express concern about physicians and patients who  fear the bleeding risk of warfarin and dabigatran: &#8220;we concluded that   encouraging the &#8216;play it safe&#8217; option  for patients and physicians   represented an undesirable stimulus to use a  less-effective regimen and   would lead to unnecessary strokes and  disability.&#8221;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Following the approval last October of dabigatran, some observers criticized the FDA&#8217;s decision not to approve the lower 110 mg dose of the drug in addition to the higher 150 mg dose. Now, in a perspective in the New England Journal of Medicine, 3 FDA officials\u00a0\u2014 B. Nhi Beasley, Ellis Unger, and Robert Temple\u00a0\u2014 explain [&hellip;]<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[495,13,16],"tags":[339,222],"class_list":["post-7841","post","type-post","status-publish","format-standard","hentry","category-anticoagulation-2","category-electrophysiology","category-vascular","tag-dabigatran","tag-fda-approvals"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/7841","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=7841"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/7841\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=7841"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=7841"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=7841"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}