According to the US Food and Drug Administration (FDA), 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.
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 deaths and health damage by banning this drug."
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."