{"id":28424,"date":"2012-04-20T14:41:01","date_gmt":"2012-04-20T18:41:01","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=news&#038;p=28424"},"modified":"2012-04-20T14:41:01","modified_gmt":"2012-04-20T18:41:01","slug":"aliskiren-tekturna-gets-new-warning-and-contraindication-from-fda","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2012\/04\/20\/aliskiren-tekturna-gets-new-warning-and-contraindication-from-fda\/","title":{"rendered":"Aliskiren (Tekturna) Gets New Warning and Contraindication from FDA"},"content":{"rendered":"<p>The FDA has issued new warnings about antihypertensive drugs containing the direct renin inhibitor aliskiren (including Tekturna, Amturnide, Takamio, and Valturna) when used in combination with ACE inhibitors or angiotensin-receptor blockers (ARBs). The FDA now states that these drug combinations are contraindicated in patients with diabetes, and it is adding a new warning to avoid the use of this combination in patients with moderate to severe renal impairment (GFR &lt;60 mL\/min).<\/p>\n<p>The new warnings are based on preliminary data from the\u00a0<a href=\"http:\/\/clinicaltrials.gov\/ct2\/show\/NCT00549757\" target=\"_parent\">ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints) clinical trial<\/a>. As\u00a0<a title=\"ALTITUDE Study of Aliskiren Terminated Early by Novartis\" href=\"http:\/\/blogs.nejm.org\/cardioexchange\/news\/altitude-study-of-aliskiren-terminated-early-by-novartis\/\">previously reported here<\/a>, ALTITUDE was terminated last December when the\u00a0independent Data Monitoring Committee (DMC) found an increased risk for nonfatal stroke, renal complications, hyperkalemia, and hypotension in patients taking aliskiren after a median follow-up of about 27 months. More than 8500 patients \u00a0with type 2 diabetes and renal disease were randomized to receive aliskiren or placebo in addition to an ACE inhibitor or an ARB.<\/p>\n<p>Click here to read\u00a0<a href=\"http:\/\/www.fda.gov\/Drugs\/DrugSafety\/ucm300889.htm\" target=\"_parent\">the FDA Drug Safety Communication<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The FDA has issued new warnings about antihypertensive drugs containing the direct renin inhibitor aliskiren (including Tekturna, Amturnide, Takamio, and Valturna) when used in combination with ACE inhibitors or angiotensin-receptor blockers (ARBs). The FDA now states that these drug combinations are contraindicated in patients with diabetes, and it is adding a new warning to avoid [&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":[660,1086,1071],"class_list":["post-28424","post","type-post","status-publish","format-standard","hentry","category-general","category-prevention","tag-aliskiren","tag-fda-warning","tag-tekturna"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/28424","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=28424"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/28424\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=28424"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=28424"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=28424"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}