{"id":1476,"date":"2010-03-19T18:50:44","date_gmt":"2010-03-19T22:50:44","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/friday-march-19-fda-in-the-news%c2%a0warning-about-high-dose-simvastatin-advisory-panel-supports-expanded-indication-for-crt-ds-watchman-approval-delayed\/"},"modified":"2011-07-19T17:45:00","modified_gmt":"2011-07-19T21:45:00","slug":"friday-march-19-fda-in-the-news%c2%a0warning-about-high-dose-simvastatin-advisory-panel-supports-expanded-indication-for-crt-ds-watchman-approval-delayed","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2010\/03\/19\/friday-march-19-fda-in-the-news%c2%a0warning-about-high-dose-simvastatin-advisory-panel-supports-expanded-indication-for-crt-ds-watchman-approval-delayed\/","title":{"rendered":"Friday March 19: FDA in the News:\u00a0Warning About High Dose Simvastatin; Advisory Panel Supports Expanded Indication for CRT-Ds; Watchman Approval Delayed"},"content":{"rendered":"<p><strong>FDA Warns About High Dose Simvastatin&#8211;<\/strong>\u00a0The FDA issued <a href=\"http:\/\/www.fda.gov\/Drugs\/DrugSafety\/PostmarketDrugSafetyInformationforPatientsandProviders\/ucm204882.htm\">a drug safety communication today about an ongoing review of high dose simvastatin and increased risk of myopathy<\/a>\u00a0based on data from the\u00a0Study of the\u00a0Effectiveness of\u00a0Additional Reductions in\u00a0Cholesterol and\u00a0Homocysteine (SEARCH) trial.<strong>FDA Panel Supports Expanded Indication for CRT-Ds&#8211; The FDA&#8217;s Circulatory System Devices Panel voted unanimously to support a broader indication for Boston Scientific CRT-D devices. The expanded indication, based on data from the MADIT-CRT trial, would include\u00a0\u00a0NYHA Class I and II\u00a0patients with LBBB, LVEF \u2264 30% and QRS duration \u2265 130ms. (<a href=\"http:\/\/bostonscientific.mediaroom.com\/index.php?s=43&amp;item=904\">Boston Scientific press release<\/a>)<\/strong><strong>FDA Delays Watchman Approval&#8211; <\/strong>The FDA has told Atritech Inc that it will have to perform another study to confirm the safety and efficacy of the Watchman Left Atrial Appendage Closure Technology before the device can gain market approval. (<a href=\"http:\/\/www.prnewswire.com\/news-releases\/atritech-announces-fda-regulatory-update-88453317.html\">Atritech press release<\/a>)<\/p>\n","protected":false},"excerpt":{"rendered":"<p>FDA Warns About High Dose Simvastatin&#8211;\u00a0The FDA issued a drug safety communication today about an ongoing review of high dose simvastatin and increased risk of myopathy\u00a0based on data from the\u00a0Study of the\u00a0Effectiveness of\u00a0Additional Reductions in\u00a0Cholesterol and\u00a0Homocysteine (SEARCH) trial.FDA Panel Supports Expanded Indication for CRT-Ds&#8211; The FDA&#8217;s Circulatory System Devices Panel voted unanimously to support a [&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-1476","post","type-post","status-publish","format-standard","hentry","category-general"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/1476","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=1476"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/1476\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=1476"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=1476"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=1476"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}