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Coming into 2007, Avandia was one of the best selling prescription medications in the United States. A series of negative medical studies have cast doubts on the safety of the drug and have started to take their toll on Avandia's sales.
The trouble for Avandia began in May, 2007 when a Cleveland Clinic study showed that patients taking Avandia had a 43% greater risk of suffering a heart attack. The study which was published in the New England journal of Medicine, reviewed more than 40 clinical studies involving 28,000 patients. Dr. Steven Nissen, who led the study, estimates that tens of thousands of people have had heart attacks as a result of Avandia. This report led the American Diabetes Association to warn doctors to use more caution when prescribing Avandia to people with type 2 diabetes.
The Cleveland Clinic study comes after an August 2006 analysis by Glaxo Smith Kline which identified a 31% increase in cardiovascular risk in Avandia patients. While the company alerted the FDA about the risks, it failed to notify doctors and patients about their findings.
As a result of the Cleveland Clinic study and the internal Glaxo Smith Kline analysis, the FDA convened a special panel to discuss the cardiovascular risks associated with Avandia. This panel voted 20-3 that the drug did, in fact, raise the chance of heart attacks. However the FDA stopped short of removing the drug from the market, voting 22-1 to allow Glaxo Smith Kline to continue marketing the drug. However the panel recommended that Glaxo Smith Kline include a new warning on Avandia's warning label about heart attacks and other cardiovascular risk.
On November 14, 2007 the FDA issued a press release announcing that Glaxo Smith Kline had agreed to add new language to its existing black box warning on Avandia about the increased risk for heart attack. A black box warning is the strongest warning the FDA can issue. Avandia has already had a black box warning about the risk of Congestive Heart Failure.
The black box warning about cardiovascular risks was not the end of the bad news for Avandia this year. On December 2, 2007 a study conducted in mice showed that Avandia may contribute to bone loss and over time may speed the progression of osteoporosis. Researchers found that Avandia affects a key cellular protein that can stimulate the production of cells which aggressively degrade bone. Since many Avandia patients are at an age where osteoporosis is already a concern, the authors of the study recommend that Avandia should be prescribed with caution.
Since the Avandia warnings, law firms have filed hundreds of Avandia lawsuits . You can easily find a law firm that is representing Avandia clients by simply searching for an Avandia lawsuit on Google or Yahoo.
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