{"id":34079,"date":"2013-01-11T09:43:17","date_gmt":"2013-01-11T14:43:17","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=news&#038;p=34079"},"modified":"2013-01-11T09:43:17","modified_gmt":"2013-01-11T14:43:17","slug":"merck-starts-to-suspend-worldwide-availability-of-tredaptive","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2013\/01\/11\/merck-starts-to-suspend-worldwide-availability-of-tredaptive\/","title":{"rendered":"Merck Starts to Suspend Worldwide Availability of Tredaptive"},"content":{"rendered":"<p>In the wake of the\u00a0<a title=\"HPS2-THRIVE: No Benefit, Signal Of Harm For Niacin\u00a0Therapy\" href=\"http:\/\/cardiobrief.org\/2012\/12\/20\/hps2-thrive-no-benefit-signal-of-harm-for-niacin-therapy\/\">negative HPS2-THRIVE<\/a>\u00a0study announced last month,\u00a0Merck\u00a0<a href=\"http:\/\/www.mercknewsroom.com\/press-release\/research-and-development-news\/merck-provides-update-next-steps-tredaptive-extended-rel\">said<\/a>\u00a0today that it was beginning to suspend the worldwide availability of Tredaptive, its combination of extended-release niacin and laropiprant.<\/p>\n<p>Merck described its decision as being &#8220;aligned&#8221; with that of the European Medicines Agency&#8217;s \u00a0Pharmacovigilance\u00a0Risk\u00a0Assessment Committee (PRAC),\u00a0which\u00a0<a href=\"http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/news_and_events\/news\/2013\/01\/news_detail_001687.jsp&amp;mid=WC0b01ac058004d5c1\">recommended on Thursday<\/a>\u00a0that drugs containing extended-release niacin and laropiprant\u00a0should be suspended. The drug is not available in the\u00a0United States. In some countries the drug combination is known as\u00a0Pelzont, Trevaclyn, or Cordaptive.<\/p>\n<p>Merck\u00a0said it was working with regulatory agencies &#8220;to develop communications for health care providers and to suspend the availability of Tredaptive, with the timing to be based on individual country regulations and processes.&#8221;\u00a0Merck\u00a0said that it is &#8220;recommending that physicians stop prescribing&#8221; the drug and that physicians begin to &#8220;review treatment plans for patients taking Tredaptive in a timely manner to discontinue&#8221; the drug.<\/p>\n<p>In December\u00a0Merck\u00a0announced that HPS2-THRIVE had not reached its primary endpoint but that treatment with the combination pill had resulted in a statistically significant increase in some nonfatal serious adverse events.\u00a0Merck\u00a0said that preliminary analyses &#8220;suggest that the adverse events fall within the following broad categories: blood and lymphatic, gastrointestinal, infections, metabolism, musculoskeletal, respiratory and skin.&#8221;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>In the wake of the\u00a0negative HPS2-THRIVE\u00a0study announced last month,\u00a0Merck\u00a0said\u00a0today that it was beginning to suspend the worldwide availability of Tredaptive, its combination of extended-release niacin and laropiprant. Merck described its decision as being &#8220;aligned&#8221; with that of the European Medicines Agency&#8217;s \u00a0Pharmacovigilance\u00a0Risk\u00a0Assessment Committee (PRAC),\u00a0which\u00a0recommended on Thursday\u00a0that drugs containing extended-release niacin and laropiprant\u00a0should be suspended. The [&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":[210,209,1605,1611,857,1604],"class_list":["post-34079","post","type-post","status-publish","format-standard","hentry","category-general","category-prevention","tag-cholesterol","tag-hdl","tag-hps2-thrive","tag-merck","tag-niacin","tag-tredaptive"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/34079","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=34079"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/34079\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=34079"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=34079"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=34079"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}