{"id":43098,"date":"2014-05-05T13:09:19","date_gmt":"2014-05-05T17:09:19","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=news&#038;p=43098"},"modified":"2014-05-05T13:09:19","modified_gmt":"2014-05-05T17:09:19","slug":"fda-comes-out-against-aspirin-for-primary-prevention","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2014\/05\/05\/fda-comes-out-against-aspirin-for-primary-prevention\/","title":{"rendered":"FDA Comes Out Against Aspirin for Primary Prevention"},"content":{"rendered":"<p>In the latest development in a long-simmering debate, the FDA has\u00a0<a href=\"http:\/\/www.fda.gov\/Drugs\/ResourcesForYou\/Consumers\/ucm390574.htm\">announced<\/a>\u00a0that aspirin should not be marketed for primary prevention for heart attack or stroke. The announcement follows the FDA&#8217;s rejection on Friday of\u00a0Bayer\u00a0Healthcare&#8217;s decade-old petition requesting approval of a primary prevention indication.\u00a0[<a href=\"http:\/\/www.regulations.gov\/contentStreamer?objectId=09000064816def58&amp;disposition=attachment&amp;contentType=pdf\">PDF of FDA rejection letter<\/a>]<\/p>\n<p>Aspirin is still widely used for primary prevention. Many physicians, including cardiologists, recommend it for some of their patients.\u00a0<a href=\"http:\/\/www.heart.org\/HEARTORG\/Conditions\/HeartAttack\/PreventionTreatmentofHeartAttack\/Aspirin-and-Heart-Disease_UCM_321714_Article.jsp\">The American Heart Association currently supports<\/a>\u00a0the use of aspirin for primary prevention when recommended by a physician in high-risk patients. \u00a0(There is widespread agreement that for secondary prevention the benefits of aspirin outweigh the risks and should be used to prevent a second heart attack or stroke after an earlier cardiovascular event.)<\/p>\n<p>In its statement the FDA said it had &#8220;reviewed the available data and does not believe the evidence supports the general use of aspirin for primary prevention of a heart attack or stroke. In fact, there are serious risks associated with the use of aspirin, including increased risk of bleeding in the stomach and brain&#8230;&#8221; The FDA reaffirmed the use of aspirin in secondary prevention.<\/p>\n<p>Cardiologist Sanjay Kaul, who often serves as an FDA consultant and advisory committee member, offered the following comment:<\/p>\n<blockquote><p>There have been nine primary prevention trials evaluating the role of aspirin in CVD. Not a single trial has been positive so far. When the data are pooled together in a meta-analysis, there is a small, but statistically significant, benefit which is counterbalanced by an equally small, but statistically significant, risk of bleeding. On balance, the totality of evidence does not yield a favorable benefit-risk ratio for aspirin in primary prevention. The FDA declined to approve aspirin for primary prevention in 2003. Overall, I agree with the FDA&#8217;s stance. The tough task ahead for professional societies is to acknowledge the tepid evidentiary support for their guideline recommendations. Equally challenging a task is that patients will have to recalibrate their opinions about aspirin for primary prevention of CVD.&#8221;<\/p><\/blockquote>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>In the latest development in a long-simmering debate, the FDA has\u00a0announced\u00a0that aspirin should not be marketed for primary prevention for heart attack or stroke. The announcement follows the FDA&#8217;s rejection on Friday of\u00a0Bayer\u00a0Healthcare&#8217;s decade-old petition requesting approval of a primary prevention indication.\u00a0[PDF of FDA rejection letter] Aspirin is still widely used for primary prevention. Many [&hellip;]<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1,7],"tags":[364,196,665],"class_list":["post-43098","post","type-post","status-publish","format-standard","hentry","category-general","category-prevention","tag-aspirin","tag-fda","tag-primary-prevention"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/43098","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=43098"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/43098\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=43098"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=43098"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=43098"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}