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Glaxo in a Soup Over Avandia 
Reuters | May 25, 2007
A leading doctor had voiced concerns about the heart risks of GlaxoSmithKline Plc's diabetes drug Avandia in a letter to the US Food and Drug Administration in 2000, years before Monday's high-profile study questioning its safety. One year later the FDA criticised the firm for minimising safety concerns, according to documents posted on the agency's Web site.
John Buse, president-elect of the American Diabetes Association and faculty member at the University of North Carolina in Chapel Hill, cited "a worrisome trend in cardiovascular deaths and severe adverse events" among patients using the drug in a letter to the agency in March 2000. |