Heading into 2007, Avandia was one of the best selling prescription medications in the United States. However, a string of negative studies may change that. Recent studies have linked the diabetes drug to heart attacks and bone fractures. More troubling to Glaxo Smith Kline, Avandia's manufacturer, is that the competing drug Actos appears to be safer than Avandia. 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. The study's author believes that thousands of people may have had heart attacks that were linked to Avandia use. The news even surprised the ADA (American Diabetes Associates) which urged doctors to be more cautious when deciding to prescribed Avandia. Before the Cleveland Clinic study was ever published, the company conducted its own internal study which revealed an increased risk of heart attacks.
Glaxo Smith Kline informed the Food and Drug Administration about the cardiovascular risk but never told Avandia patients or doctors prescribing Avandia. 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. While the black box warning about heart attacks was troubling for Avandia, the negative news continued.
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.
Mark & Associates, P.C. is a leading drug side injury law firm that is currently representing victims of Avandia side effects. To request a free legal consultation please call 1-866-50-RIGHTS.