{"id":40388,"date":"2013-11-25T18:43:06","date_gmt":"2013-11-25T23:43:06","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=news&p=40388"},"modified":"2013-11-25T18:43:33","modified_gmt":"2013-11-25T23:43:33","slug":"fda-removes-restrictions-on-avandia","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2013\/11\/25\/fda-removes-restrictions-on-avandia\/","title":{"rendered":"FDA Removes Restrictions on Avandia"},"content":{"rendered":"

In a remarkable climax to a long-running drama,\u00a0the FDA today lifted major restrictions on rosiglitazone<\/a>\u00a0(Avandia,\u00a0GlaxoSmithKline). The drug has been the subject of \u00a0intense\u00a0criticism and controversy since the 2007 publication of\u00a0the famous Nissen meta-analsysis<\/a>\u00a0that first raised the possibility that the blockbuster diabetes drug might increase the risk of heart attack and cardiovascular death.<\/p>\n

The FDA said its actions were “consistent with the recommendations of expert advisory committees.” In June of this year an FDA panel reviewed re-adjudicated data from the RECORD (Rosiglitazone Evaluated for Cardiovascular Outcomes and\u00a0Regulation\u00a0of Glycemia in Diabetes) trial and concluded that the trial had not found an elevated risk of heart attack or death associated with rosiglitazone.<\/p>\n

\u201cOur actions today reflect the most current scientific knowledge about the risks and benefits of this drug,\u201d said Janet Woodcock, director of the FDA\u2019s Center for Drug Evaluation and Research, in an FDA press release<\/a>. \u201cGiven these new results, our level of concern is considerably reduced; thus, we are requiring the removal of certain prescribing restrictions.\u201d<\/p>\n

As a result of today’s FDA action rosiglitzone will be much easier to obtain. Physicians, pharmacies, and patients will no longer have to participate in the stringent\u00a0Risk Evaluation and Mitigation Strategy (REMS) program.<\/p>\n

The rosiglitazone label will also be revised to reflect the FDA’s changed perception of the drug. The current indication for rosiglitazone is severely limited. The new label will be similar to other available diabetes drugs and will state that it may be used to help control blood sugar in type 2 diabetics.<\/p>\n

The FDA also said it was “releasing” GSK “from the postmarket requirement to conduct” the\u00a0TIDE<\/a>\u00a0(Thiazolidinedione Intervention with Vitamin D Evaluation) trial comparing rosiglitazone to pioglitazone and other diabetes drugs. The FDA said it had “concluded that this trial is no longer necessary or feasible.”<\/p>\n

The FDA announcement “is about the FDA’s effort to save face,” Steve Nissen told\u00a0the\u00a0<\/a>Associated Press<\/a>.<\/em>\u00a0“A single reanalysis of a trial does not exonerate a drug where all the other data point to increased cardiovascular risks.” He said he does not think that most physicians will now begin to prescribe the drug again.<\/p>\n

Harlan Krumholz offered the following comment:<\/p>\n

The turn of events is surprising given that no substantial information has been made available since the original decision. I don’t know how we will ever know the truth until GSK completely releases the Avandia trial data at the patient level.”<\/p><\/blockquote>\n

 <\/p>\n","protected":false},"excerpt":{"rendered":"

In a remarkable climax to a long-running drama,\u00a0the FDA today lifted major restrictions on rosiglitazone\u00a0(Avandia,\u00a0GlaxoSmithKline). The drug has been the subject of \u00a0intense\u00a0criticism and controversy since the 2007 publication of\u00a0the famous Nissen meta-analsysis\u00a0that first raised the possibility that the blockbuster diabetes drug might increase the risk of heart attack and cardiovascular death. The FDA said […]<\/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":[199,200,196,205],"class_list":["post-40388","post","type-post","status-publish","format-standard","hentry","category-general","tag-avandia","tag-diabetes","tag-fda","tag-rosiglitazone"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/40388","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=40388"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/40388\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=40388"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=40388"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=40388"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}