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Avandia Information

What is Avandia?

We are NOT accepting any new Avandia cases

 


Avandia, generically known as rosiglitazone, is a drug used to help Type 2 diabetes patients with insulin resistance. Manufactured by GlaxoSmithKline, Avandia is in the thiazolidinedione (TZD) class of drugs, which are the first class of medications designed to reverse the basic problem in Type 2 diabetes of resistance to insulin. In May 2007, the New England Journal of Medicine published an analysis linking Avandia to increased risk of heart attacks. The meta-analysis reviewed 42 studies and found patients taking Avandia to be at a 43% higher risk of heart attacks.

Public Citizen Wants FDA To Issue Avandia Recall Order Due To "New" Liver Failure Cases
This October 2008 HRG document, "Petition to Immediately Ban Diabetes Drug Rosiglitazone (AVANDIA) (HRG Publication #1848)", not only discusses the previously known cardiovascular side effects associated with Avandia, such as heart attacks, but also brings attention to recently found information concerning 14 cases of liver failure, of which 12 resulted in death.


FDA Adds to Avandia Black Box Warning In November 2007
The U.S. Food and Drug Administration announced on November 14, 2007 that the manufacturer of Avandia (rosiglitazone), a drug used to treat type 2 diabetes, has agreed to add a new black box warning on the drug's labeling about potential increased risk for heart attacks. This increased risk is unique to Avandia and not associated with other drugs in the same class.


FDA's Weak Response To May 2007 News That Avandia Increases The Risk Of Heart Attacks And Cardiovascular Deaths
The findings from a new meta-analysis by Nissen and Wolski are disturbing insofar that they show patients taking Avandia had a 43% higher risk of heart attacks and a 64% elevated rate of cardiovascular death. The FDA's analysis of all available Avandia data is ongoing and at this time the agency is not asking GlaxoSmithKline to recall Avandia, suspend sales, nor take any other particular action.


May 2007 New England Journal Of Medicine Article Links Avandia to Risk Of Heart Attack, Or Myocardial Infarction
In their article, "Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes", Steven E. Nissen, M.D., and Kathy Wolski, M.P.H., report on a meta-analysis of data from 42 clinical trials that found a 43% increased risk of heart attack among Type 2 diabetics treated with Avandia (rosiglitazon). This Avandia - heart attack article was published online by the New England Journal of Medicine (NEJM) on May 21, 2007; the article will appear in the June 14, 2007 print edition of this leading medical journal.



 

We are NOT accepting any new Avandia cases

 


Resources

 
 
 

January 2010 Senate Committee on Finance report on Avandia (Free PDF)

February 19, 2010 New York Times story (Free)

February 20, 2010 GlaxoSmithKline news release on Senate report (Free PDF)

February 20, 2010 GlaxoSmithKline news release on Times story (Free PDF)


 


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