{"id":354954,"date":"2010-02-23T16:34:00","date_gmt":"2010-02-23T21:34:00","guid":{"rendered":"tag:typepad.com,2003:post-6a00d8341c89dd53ef01310f29a4cd970c"},"modified":"2010-02-24T08:13:44","modified_gmt":"2010-02-24T13:13:44","slug":"when-considering-a-possible-avandia-recall-liver-injury-side-effects-should-be-a-factor","status":"publish","type":"post","link":"https:\/\/mereja.media\/index\/354954","title":{"rendered":"When Considering A Possible Avandia Recall, Liver Injury Side Effects Should Be A Factor"},"content":{"rendered":"
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Heart Risk\u00a0Is Current Focus\u00a0Due To GlaxoSmithKline Past Conduct; But Public Citizen Has Pointed\u00a0The Liver Failure Case Reports Linked To Avandia, Also
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(Posted by Tom Lamb at <\/strong>DrugInjuryWatch.com<\/strong><\/font><\/span><\/a>)<\/strong><\/font><\/p>\n

As some of you may recall, in October 2008 Public Citizen petitioned the FDA to ban the sale of the diabetes drug Avandia (rosiglitazone) in the U.S.<\/a> because its risks, which include heart attack and heart failure in addition to liver toxicity, far outweigh its benefits and because much safer alternatives exist for treating Type 2 diabetes.<\/p>\n

To our knowledge, there\u00a0is still\u00a0no word from the FDA about how long the agency will need to make a determination on the Avandia recall requested by Public Citizen.<\/p>\n

More recently, in late July 2009, a new medical journal article about Avandia and liver failure was published in Pharmacoepidemiology and Drug Safety<\/em>.\u00a0 This article, “Case series of liver failure associated with rosiglitazone and pioglitazone.”<\/a>\u00a0— by James S. Floyd, MD, Elizabeth Barbehenn, PhD, Peter Lurie, MD, MPH, and Sidney M. Wolfe, MD, of Public Citizen’s Health Research Group — seemingly adds further support to the contention that Avandia can cause liver failure and should be recalled by the FDA.<\/p>\n

Soon thereafter a July 22, 2009 press release, “Rigorous Study Adds to Case That FDA Should Ban the Diabetes Drug”<\/a>, was issued by Public Citizen in connection with this new Avandia medical journal article.<\/p>\n

Those few\u00a0items, above,\u00a0suggest that the serious liver injury risk associated with Avandia\u00a0could\u00a0(and should)\u00a0be a factor in the FDA’s determination about whether to order an Avandia recall, or not.<\/p>\n

As far as when any\u00a0Avandia recall determination will be made by the FDA, currently it seems this issue will have to wait until a joint public meeting of the Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees in July 2010. At that FDA meeting, the Advisory Committee will provide an updated assessment of the risks and benefits of Avandia.<\/p>\n

Returning to the present, during this past week almost all (if not all) of the Avandia safety debate has had to do with the cardiac risks linked to Avandia, namely heart attacks and heart failure. <\/p>\n

First, there was a February 19, 2010 New York Times<\/em> (NYT<\/em>) article, “Research Ties Diabetes Drug to Heart Woes”<\/a>, by Gardiner Harris, which\u00a0was based on “internal FDA reports” and a January 2010 Senate Committee on Finance staff report about Avandia<\/a> which concludes: “The totality of evidence suggests that [GlaxoSmithKline] was aware of the possible cardiac risks associated with Avandia years before such evidence became public.”<\/p>\n

Immediately afterward, in two separate press releases, GlaxoSmithKline (GSK) disputed the reports set forth in the February 19 NYT<\/em> article<\/a> and took issue with the conclusions of the Senate Committee’s Avandia report<\/a>.\u00a0 Essentially, the party line for GSK is that “the scientific evidence simply does not establish that Avandia increases ischemic cardiovascular risk or causes myocardial ischemic events.”<\/p>\n

And then there is renowned cardiologist Steven Nissen, of the Cleveland Clinic, who has been vocal critic of Avandia due to safety reasons.\u00a0 To learn more about Dr. Nissen’s position on Avandia, we refer you to these two items:<\/p>\n

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1)\u00a0 A\u00a0February 23, 2010\u00a0New York Times<\/em> (NYT<\/em>)\u00a0story, “A Face-Off on the Safety of a Drug for Diabetes”<\/a>, by Gardiner Harris, again; and,<\/p>\n

2)\u00a0 This\u00a0recent medical journal\u00a0article from European Heart Journal<\/em>, “The rise and fall of rosiglitazone”<\/a>, by Steven E. Nissen — Advance Access published February 12, 2010 (includes a 1999-2009 timeline).<\/p>\n<\/blockquote>\n

Our law firm is continuing to\u00a0investigate Avandia injury and death cases<\/a> involving liver failure as well as heart attack or heart failure.<\/p>\n

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DrugInjuryLaw.com<\/font><\/span><\/strong><\/a>: Legal Information And News About Prescription Drug Side Effects<\/strong><\/span><\/span><\/span><\/span><\/p>\n