{"id":26982,"date":"2012-02-28T15:36:23","date_gmt":"2012-02-28T20:36:23","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=news&#038;p=26982"},"modified":"2012-02-28T15:36:23","modified_gmt":"2012-02-28T20:36:23","slug":"fda-revises-the-safety-labeling-of-statins","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2012\/02\/28\/fda-revises-the-safety-labeling-of-statins\/","title":{"rendered":"FDA Revises the Safety Labeling of Statins"},"content":{"rendered":"<p>The FDA today\u00a0<a href=\"http:\/\/www.fda.gov\/Drugs\/DrugSafety\/ucm293101.htm\">announced<\/a>\u00a0important new changes to the safety language on the labels of statins:<\/p>\n<p><strong>Routine periodic monitoring of liver enzymes is no longer recommended.<\/strong>\u00a0Serious liver injury associated with statins is &#8220;rare and unpredictable in individual patients&#8221; and &#8220;routine periodic monitoring of liver enzymes does not appear to be effective in detecting or preventing this rare side effect,&#8221; according to the FDA. \u00a0The agency now says that liver enzyme tests only need to be performed before starting statin therapy and &#8220;as clinically indicated thereafter.&#8221;<\/p>\n<p><strong>Memory loss and confusion\u00a0will now be included in the label.\u00a0<\/strong>But, the FDA notes, reports about the cognitive effects of statins have usually &#8220;not been serious and the patients\u2019 symptoms were reversed by stopping the statin.&#8221; In\u00a0<a href=\"http:\/\/www.forbes.com\/sites\/matthewherper\/2012\/02\/28\/fda-cautions-on-memory-diabetes-in-statin-drugs\/\">a story published on\u00a0<em>Forbes<\/em><\/a>, Matt Herper writes that the &#8220;new labeling will lead patients and doctors to take memory issues on the drugs more seriously, and it will also lead patients to link normal lapses of memory to their drugs.&#8221;<\/p>\n<p><strong>The increased risk of hyperglycemia and type 2 diabetes will be mentioned in the label<\/strong>.\u00a0The label will now reflect data showing the small increased risk for type 2 diabetes in people taking statins.<\/p>\n<p>The FDA is also making specific recommendations about\u00a0<strong>lovastatin<\/strong>, noting that when used with some other drugs, lovastatin can increase the risk for muscle injury.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The FDA today\u00a0announced\u00a0important new changes to the safety language on the labels of statins: Routine periodic monitoring of liver enzymes is no longer recommended.\u00a0Serious liver injury associated with statins is &#8220;rare and unpredictable in individual patients&#8221; and &#8220;routine periodic monitoring of liver enzymes does not appear to be effective in detecting or preventing this rare [&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":[196,584],"class_list":["post-26982","post","type-post","status-publish","format-standard","hentry","category-general","category-prevention","tag-fda","tag-statins"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/26982","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=26982"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/26982\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=26982"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=26982"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=26982"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}