FDA Warned About Avandia's Risks Seven Years Ago
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Dr. John B. Buse is the chief of endocrinology at the University of North Carolina and is about to become the president of the American Diabetes Association. In 2000, Dr. Buse sent a letter to the FDA warning of the heart risks of the drug Avandia. The letter cited
"a worrisome trend in cardiovascular deaths and severe adverse events"
among patients using Avandia.
A search of the FDA's database revealed that the agency reprimanded Avandia's manufacturer, GlaxoSmithKline, in 2001 for trying to minimize Avandia's risks. Six years later, Glaxo is responding the same way to the article and editorial published this Monday in the New England Journal of Medicine. Dr. Buse acknowledged to the New York Times yesterday that his opinion of Avandia had not changed since he wrote the 2000 letter. Since then, Avandia has been used by an estimated six million people in the United States. Glaxo marketed the drug as a safer alternative to a similar diabetes drug, Rezulin, which was withdrawn from the market in 2000 because it caused serious liver damage in some patients.
Jerome L. Avorn, M.D., a doctor and Harvard professor, said that with both Rezulin and Avandia,
"
there were signals of a very dangerous side effect that were ignored." "Then massive marketing created a tremendous uptake of the drug."
Last year, worldwide sales of Avandia topped $3 billion, making it one of Glaxo's best selling drugs. Is it any wonder Glaxo has been hiding the ball from diabetes patients and their doctors for seven years?