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July 25, 2009

Avandia Again Linked with Liver Failure

In the July 22, 2009, edition of the peer-reviewed medical journal Pharmacoepidemiology and Drug Safety researchers identified eleven cases of severe liver toxicity and deaths that were linked to the popular Type 2 diabetes drug Avandia (or rosiglitazone) manufactured by GlaxoSmithKline.  These cases were identified after review of Adverse Event Reports spontaneously submitted to the FDA between 1997 through 2006.  However, many believe that the number of cases identified in the study only represent a small fraction of actual liver failure events due to low reporting submissions to the FDA.  

 

Since being introduced in 1999, the drug has already been linked to serious health risks including heart attack and heart failure following a May 2007 study published in The New England Journal of Medicine connecting the drug with increased heart attack risk.   In October 2008, increased safety concerns prompted the American Diabetes Association (ADA) and the European Association for the Study of Diabetes to unanimously advise against using Avandia.  Still, approximately three million prescriptions were written for Avandia in 2008.  Several public watch groups including Public Citizen have been imploring that the FDA immediately ban Avandia.

 

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