{"id":8797,"date":"2011-06-16T11:04:49","date_gmt":"2011-06-16T15:04:49","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?p=8797"},"modified":"2011-07-19T17:44:22","modified_gmt":"2011-07-19T21:44:22","slug":"fda-says-pioglitazone-use-is-linked-to-bladder-cancer","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2011\/06\/16\/fda-says-pioglitazone-use-is-linked-to-bladder-cancer\/","title":{"rendered":"FDA Says Pioglitazone Use Is Linked to Bladder Cancer"},"content":{"rendered":"<p>The FDA has issued <a href=\"http:\/\/www.fda.gov\/Drugs\/DrugSafety\/ucm259150.htm\">a safety announcement <\/a>stating that the use of pioglitazone (Actos) for more than 1 year may be \u00a0associated with increased risk for bladder cancer. The FDA announcement follows last week&#8217;s <a href=\"http:\/\/blogs.nejm.org\/cardioexchange\/pioglitazone-actos-suspended-in-france-over-cancer-concerns\/\" target=\"_blank\">suspension of the drug<\/a> in France and Germany by regulatory authorities in those countries.<\/p>\n<p>The FDA said that pioglitazone should not be used in patients with active bladder cancer and should be used &#8220;with caution&#8221; in patients with a history of bladder cancer.<\/p>\n<p>The FDA announcement was based on an\u00a0<a href=\"http:\/\/www.fda.gov\/Drugs\/DrugSafety\/ucm226214.htm\">ongoing safety review<\/a> utilizing interim 5-year data from an ongoing epidemiological study. Although no overall increase in bladder cancer was found in the analysis, an increase in bladder cancer &#8220;was noted among patients with the longest exposure to pioglitazone, and in those exposed to the highest cumulative dose of pioglitazone.&#8221;<\/p>\n<p>Compared with people who never used pioglitazone, those who were treated with the drug for more than 2 years had a hazard ratio for bladder cancer of 1.4 (95% CI, 1.03-2.0). The FDA calculated that among patients who used pioglitazone for more than 12 months, there would be 27.5 excess cases of bladder cancer per 100,000 person-years of follow-up (compared with patients who never used the drug).<\/p>\n<p>The FDA also said it was &#8220;aware&#8221; of <a href=\"http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/news_and_events\/news\/2011\/06\/news_detail_001275.jsp&amp;murl=menus\/news_and_events\/news_and_events.jsp&amp;mid=WC0b01ac058004d5c1\">the French epidemiological study<\/a> that sparked the European suspensions. The French study documented a significantly greater overall risk for bladder cancer among people who took pioglitazone than among those who took other diabetes drugs\u00a0(HR, 1.22; 95% CI, 1.03-1.43), as well as a significantly elevated risk among people who used the drug for longer than 1 year (HR 1.34; 95% CI, 1.02-1.75).<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The FDA has issued a safety announcement stating that the use of pioglitazone (Actos) for more than 1 year may be \u00a0associated with increased risk for bladder cancer. The FDA announcement follows last week&#8217;s suspension of the drug in France and Germany by regulatory authorities in those countries. The FDA said that pioglitazone should not [&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],"tags":[871,196,415],"class_list":["post-8797","post","type-post","status-publish","format-standard","hentry","category-general","tag-bladder-cancer","tag-fda","tag-pioglitazone"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/8797","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=8797"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/8797\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=8797"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=8797"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=8797"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}