{"id":1371,"date":"2009-11-23T12:45:45","date_gmt":"2009-11-23T17:45:45","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/fda-investigating-possible-link-between-sibutramine-and-cardiovascular-events\/"},"modified":"2011-07-19T17:45:06","modified_gmt":"2011-07-19T21:45:06","slug":"fda-investigating-possible-link-between-sibutramine-and-cardiovascular-events","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2009\/11\/23\/fda-investigating-possible-link-between-sibutramine-and-cardiovascular-events\/","title":{"rendered":"FDA Investigating Possible Link Between Sibutramine and Cardiovascular Events"},"content":{"rendered":"<p>The FDA has issued\u00a0<a href=\"http:\/\/www.fda.gov\/Drugs\/DrugSafety\/PostmarketDrugSafetyInformationforPatientsandProviders\/DrugSafetyInformationforHeathcareProfessionals\/ucm191650.htm\">an early communication<\/a> regarding a possible increased risk for adverse cardiovascular events associated with sibutramine (Meridia), a prescription drug used to manage obesity.<\/p>\n<p>A postmarketing study was conducted in some 10,000 obese patients with stable heart disease or type 2 diabetes plus another risk factor. Preliminary findings show more cardiovascular events occurred in patients who took sibutramine compared with placebo (11.4% vs. 10.0%).<\/p>\n<p>Pending further data analysis, the FDA recommends following current\u00a0<a href=\"http:\/\/www.fda.gov\/downloads\/Drugs\/DrugSafety\/PublicHealthAdvisories\/UCM130745.pdf\">labeling instructions<\/a> to avoid the drug in patients with histories of coronary artery disease, congestive heart failure, arrhythmia, or stroke. In addition, the FDA notice says, &#8220;healthcare professionals should continue to evaluate the benefits and risks of sibutramine, taking into account individual patient medical histories.&#8221;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The FDA has issued\u00a0an early communication regarding a possible increased risk for adverse cardiovascular events associated with sibutramine (Meridia), a prescription drug used to manage obesity. A postmarketing study was conducted in some 10,000 obese patients with stable heart disease or type 2 diabetes plus another risk factor. Preliminary findings show more cardiovascular events occurred [&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],"tags":[],"class_list":["post-1371","post","type-post","status-publish","format-standard","hentry","category-general"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/1371","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=1371"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/1371\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=1371"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=1371"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=1371"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}