The bad news for Avandia keeps coming. In addition to being linked to Congestive Heart Failure and Heart Attacks, Avandia has now been linked to bone fractures. The latest negative study on Avandia comes just weeks after the FDA forced the drug's manufacturer to revise the black box warning on the label to include information about heart attacks.
In May, 2007 the Cleveland Clinic issued a study which 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. The news even surprised the ADA (American Diabetes Associates) which urged doctors to be more cautious when deciding to prescribed Avandia.
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.
Finally in mid-November the Food and Drug Administration announced that Avandia's manufacturer agreed to add language to the drug's existing black box warning about the risk of heart attacks. A black box warning is the strongest warning the FDA can issue. Avandia had already been linked to Congestive heart failure of CHF.
The black box warning about cardiovascular risks was not the end of the bad news for Avandia this year. A recent study revealed that the popular diabetes drug may be linked to osteoporosis and other debillatating side effects. The authors of the study found that the diabetes drug can in essence break down bones. 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.
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