{"id":10681,"date":"2010-09-23T13:54:05","date_gmt":"2010-09-23T17:54:05","guid":{"rendered":"http:\/\/asweetlife.org\/?p=10681"},"modified":"2015-12-30T02:43:52","modified_gmt":"2015-12-30T07:43:52","slug":"fda-to-introduce-new-restrictions-on-avandia-use","status":"publish","type":"post","link":"https:\/\/asweetlife.org\/?p=10681","title":{"rendered":"FDA to Introduce New Restrictions on Avandia Use"},"content":{"rendered":"<p style=\"text-align: justify;\"><a href=\"https:\/\/asweetlife.org\/wp-content\/uploads\/2010\/09\/GSK-Logo.jpg\" rel=\"mfp\"><img decoding=\"async\" class=\"alignleft size-full wp-image-10683 lazyload\" title=\"GSK Logo\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" data-src=\"https:\/\/asweetlife.org\/wp-content\/uploads\/2010\/09\/GSK-Logo.jpg\" alt=\"\" width=\"157\" height=\"157\" \/><\/a>Following an ongoing FDA review of\u00a0 the diabetes drug <a href=\"https:\/\/asweetlife.org\/a-sweet-life-staff\/in-the-news\/type-2-in-the-news\/a-sweet-life-staff\/in-the-news\/drugs-treatment\/diabetes-drug-maker-hid-study-data\/8993\/\" target=\"_blank\">Avandia<\/a> <span><span><span style=\"font-size: small;\"><span style=\"font-size: small;\">(rosiglitazone)<\/span><\/span><\/span><\/span> the FDA will require that GlaxoSmithKline (GSK) develop a restricted access program for Avandia under a risk evaluation and mitigation strategy, or REMS. Under the REMS, Avandia will be available to new patients only if they are unable to achieve glucose control on other medications and are unable to take <a href=\"https:\/\/asweetlife.org\/a-sweet-life-staff\/in-the-news\/type-2-in-the-news\/a-sweet-life-staff\/in-the-news\/type-2-in-the-news\/fda-medwatch-actos-pioglitazone-ongoing-safety-review-potential-increased-risk-of-bladder-cancer\/10487\/\" target=\"_blank\">Actos<\/a> (pioglitazone), the only other drug in this class. Current users of Avandia who are benefiting from the drug will be able to continue using the medication if they choose to do so.<\/p>\n<p style=\"text-align: justify;\">Doctors will have to attest to and document their patients&#8217; eligibility; patients will have to review statements describing the cardiovascular safety concerns associated with this drug and acknowledge they understand the risks. The agency anticipates that the REMS will limit use of Avandia significantly.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Following an ongoing FDA review of  the diabetes drug Avandia (rosiglitazone) the FDA will require that GlaxoSmithKline (GSK) develop a restricted access program for Avandia under a risk evaluation and mitigation strategy, or REMS. Under the REMS, Avandia will be available to new patients only if they are unable to achieve glucose control on other medications and are unable to take Actos (pioglitazone), the only other drug in this class&#8230;<\/p>\n","protected":false},"author":131,"featured_media":29422,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"","_relevanssi_noindex_reason":"","footnotes":""},"categories":[1442],"tags":[590],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v22.9 (Yoast SEO v22.9) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>FDA to Introduce New Restrictions on Avandia Use<\/title>\n<meta name=\"description\" content=\"FDA to require GlaxoSmithKline (GSK) to develop a restricted access program for Avandia (rosiglitazone) under a risk evaluation and mitigation strategy - REMS.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/asweetlife.org\/?p=10681\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"ASweetLife Team\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/asweetlife.org\/?p=10681\",\"url\":\"https:\/\/asweetlife.org\/?p=10681\",\"name\":\"FDA to Introduce New Restrictions on Avandia Use\",\"isPartOf\":{\"@id\":\"https:\/\/asweetlife.org\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/asweetlife.org\/?p=10681#primaryimage\"},\"image\":{\"@id\":\"https:\/\/asweetlife.org\/?p=10681#primaryimage\"},\"thumbnailUrl\":\"https:\/\/asweetlife.org\/wp-content\/uploads\/2010\/09\/gsk-logo.jpg\",\"datePublished\":\"2010-09-23T17:54:05+00:00\",\"dateModified\":\"2015-12-30T07:43:52+00:00\",\"author\":{\"@id\":\"https:\/\/asweetlife.org\/#\/schema\/person\/5de2b093878b82b0ea97917f8fd72585\"},\"description\":\"FDA to require GlaxoSmithKline (GSK) to develop a restricted access program for Avandia (rosiglitazone) under a risk evaluation and mitigation strategy - REMS.\",\"breadcrumb\":{\"@id\":\"https:\/\/asweetlife.org\/?p=10681#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/asweetlife.org\/?p=10681\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/asweetlife.org\/?p=10681#primaryimage\",\"url\":\"https:\/\/asweetlife.org\/wp-content\/uploads\/2010\/09\/gsk-logo.jpg\",\"contentUrl\":\"https:\/\/asweetlife.org\/wp-content\/uploads\/2010\/09\/gsk-logo.jpg\",\"width\":225,\"height\":166,\"caption\":\"gsk-logo\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/asweetlife.org\/?p=10681#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/asweetlife.org\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"FDA to Introduce New Restrictions on Avandia Use\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/asweetlife.org\/#website\",\"url\":\"https:\/\/asweetlife.org\/\",\"name\":\"ASweetLife\",\"description\":\"The Diabetes Magazine\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/asweetlife.org\/?s={search_term_string}\"},\"query-input\":\"required name=search_term_string\"}],\"inLanguage\":\"en-US\"},{\"@type\":\"Person\",\"@id\":\"https:\/\/asweetlife.org\/#\/schema\/person\/5de2b093878b82b0ea97917f8fd72585\",\"name\":\"ASweetLife Team\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/asweetlife.org\/#\/schema\/person\/image\/\",\"url\":\"https:\/\/secure.gravatar.com\/avatar\/ba76b5c6c27d32738b13f9a8a5cfcf02?s=96&d=mm&r=g\",\"contentUrl\":\"https:\/\/secure.gravatar.com\/avatar\/ba76b5c6c27d32738b13f9a8a5cfcf02?s=96&d=mm&r=g\",\"caption\":\"ASweetLife Team\"},\"url\":\"https:\/\/asweetlife.org\/?author=131\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"FDA to Introduce New Restrictions on Avandia Use","description":"FDA to require GlaxoSmithKline (GSK) to develop a restricted access program for Avandia (rosiglitazone) under a risk evaluation and mitigation strategy - REMS.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/asweetlife.org\/?p=10681","twitter_misc":{"Written by":"ASweetLife Team","Est. reading time":"1 minute"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/asweetlife.org\/?p=10681","url":"https:\/\/asweetlife.org\/?p=10681","name":"FDA to Introduce New Restrictions on Avandia Use","isPartOf":{"@id":"https:\/\/asweetlife.org\/#website"},"primaryImageOfPage":{"@id":"https:\/\/asweetlife.org\/?p=10681#primaryimage"},"image":{"@id":"https:\/\/asweetlife.org\/?p=10681#primaryimage"},"thumbnailUrl":"https:\/\/asweetlife.org\/wp-content\/uploads\/2010\/09\/gsk-logo.jpg","datePublished":"2010-09-23T17:54:05+00:00","dateModified":"2015-12-30T07:43:52+00:00","author":{"@id":"https:\/\/asweetlife.org\/#\/schema\/person\/5de2b093878b82b0ea97917f8fd72585"},"description":"FDA to require GlaxoSmithKline (GSK) to develop a restricted access program for Avandia (rosiglitazone) under a risk evaluation and mitigation strategy - REMS.","breadcrumb":{"@id":"https:\/\/asweetlife.org\/?p=10681#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/asweetlife.org\/?p=10681"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/asweetlife.org\/?p=10681#primaryimage","url":"https:\/\/asweetlife.org\/wp-content\/uploads\/2010\/09\/gsk-logo.jpg","contentUrl":"https:\/\/asweetlife.org\/wp-content\/uploads\/2010\/09\/gsk-logo.jpg","width":225,"height":166,"caption":"gsk-logo"},{"@type":"BreadcrumbList","@id":"https:\/\/asweetlife.org\/?p=10681#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/asweetlife.org\/"},{"@type":"ListItem","position":2,"name":"FDA to Introduce New Restrictions on Avandia Use"}]},{"@type":"WebSite","@id":"https:\/\/asweetlife.org\/#website","url":"https:\/\/asweetlife.org\/","name":"ASweetLife","description":"The Diabetes Magazine","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/asweetlife.org\/?s={search_term_string}"},"query-input":"required name=search_term_string"}],"inLanguage":"en-US"},{"@type":"Person","@id":"https:\/\/asweetlife.org\/#\/schema\/person\/5de2b093878b82b0ea97917f8fd72585","name":"ASweetLife Team","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/asweetlife.org\/#\/schema\/person\/image\/","url":"https:\/\/secure.gravatar.com\/avatar\/ba76b5c6c27d32738b13f9a8a5cfcf02?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/ba76b5c6c27d32738b13f9a8a5cfcf02?s=96&d=mm&r=g","caption":"ASweetLife Team"},"url":"https:\/\/asweetlife.org\/?author=131"}]}},"_links":{"self":[{"href":"https:\/\/asweetlife.org\/index.php?rest_route=\/wp\/v2\/posts\/10681"}],"collection":[{"href":"https:\/\/asweetlife.org\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/asweetlife.org\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/asweetlife.org\/index.php?rest_route=\/wp\/v2\/users\/131"}],"replies":[{"embeddable":true,"href":"https:\/\/asweetlife.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=10681"}],"version-history":[{"count":0,"href":"https:\/\/asweetlife.org\/index.php?rest_route=\/wp\/v2\/posts\/10681\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/asweetlife.org\/index.php?rest_route=\/wp\/v2\/media\/29422"}],"wp:attachment":[{"href":"https:\/\/asweetlife.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=10681"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/asweetlife.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=10681"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/asweetlife.org\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=10681"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}