May 26, 2007FDA confirms Avandia heart attack risk
Somewhere between 60,000 and 100,000 heart attacks have been linked with Avandia side effects, and 20 more occur every day. GlaxoSmithKline, the British-based maker of Avandia, has been criticized for failing to warn the public about this risk of heart attack. The FDA has also come under heavy criticism for moving too slowly and not adequately protecting consumers.Senator Charles Grassley of Iowa questions why the FDA did not inform the public after receiving this data from GSK in 2005. He had recommended a “black-box” warning about Avandia’s heart attack risk, but the agency chose to await the results of an ongoing study before taking action. That study is not due out until 2009 at the earliest and more Avandia deaths may occur in the meantime.
Avandia is a popular medication used by more than six million people for the treatment of type 2 diabetes. Its sales in the United States last year topped $2.2 billion. GSK is vigorously denying the conclusions of a study conducted by Dr. Steven Nissen, published in the May 2007 issue of the New England Journal of Medicine. But the FDA’s own analysis showed that people taking Avandia are at a 31% greater risk of heart attack.