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Will The FDA Ban Avandia?

Posted by attorney Brett Emison

Two new studies -- one published in the Journal of the American Medical Association (JAMA) and another published in the Archives of Internal Medicine -- showed that diabetes drug Avandia caused an increased risk of having a heart attack and created higher risk of stroke, heart failure and all-cause death when compared to a similar medication called pioglitazone (Actos).

One of the studies' lead authors, Dr. David Graham, wants Avandia pulled from the market. According to the Associated Press, Dr. Graham said:

"The evidence is overwhelming. There is not a single study where those two drugs [Avandia and Actos] are compared where Avandia doesn't look worse than Actos. How many studies do you have to do before you come to your senses?"

There is an FDA hearing to evaluate Avandia scheduled for July 2010.

Heart Risks

According to the US Food and Drug Administration, there is "a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia." Data given to the FDA by GlaxoSmithKline suggest a 30-40% increase in the risk of heart attacks and other heart-related deaths. In November 2007, the FDA mandated that a "black box warning" be included on Avandia packaging to warn of increased risk of heart attacks and heart-related chest pain.

Liver Risks

The national, non-profit consumer advocacy group, Public Citizen, has identified 14 cases of Avandia-induced liver failure, which resulted in 12 deaths. The cases were discovered through the FDA Adverse Event Reporting System, which collects information on dangerous drug reactions. "The scientific consensus against Avandia is overwhelming," said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group. "The timing of these findings should give the FDA the momentum it needs to act swiftly to prevent further needless deathsa nd health damage by banning this drug."

Bone Fractures

A study conducted by Swiss researchers has found a correlation between Avandia use and bone fractures. The Swiss study looked at medical records of more than 1,000 patients who used Avandia and suffered broken bones between 1994-2005. They found that there was a significant increase in patients suffering broken bones when taking Avandia compared to diabetic patients not taking the drug.

Despite this evidence, at the time of writing, it remains unclear whether the FDA will finally pull Avandia from the market with the FDA committee meets in July 2010.

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