FDA studies diabetes drug Avandia, heart attack links
The U.S. Food and Drug Administration recently acknowledged that its evaluation of the diabetes pill Avandia confirms that as many as 60,000 to 100,000 heart attacks might be linked to its use since it came on the market eight years ago.
The confirmation comes after the release last month of an analysis led by Cleveland Clinic cardiology chief Dr. Steven Nissen concluded that Avandia raised the risk of heart attacks by 43 percent.
Sen. Charles Grassley, R-Iowa, said on the Senate floor recently that safety watchdogs within the federal FDA “several months ago” recommended a “black box” the strongest possible warning on the drug’s label.
Grassley complained that FDA officials have said they want to wait for results of an ongoing study that will not be available for two more years before making a decision.
“That’s a long time from now when you have millions of Americans taking this drug,” he said. “Those numbers seem like a high enough threshold to me for the FDA to warn the American people of the possibility of a problem.”
Avandia, sold by the British company GlaxoSmithKline PLC, is a blockbuster medication used to treat Type 2 diabetes, the most common form of the disease. More than 6 million people worldwide have taken the drug, whose U.S. sales topped $2.2 billion last year.
GlaxoSmithKline strongly disputes the Cleveland Clinic conclusions. Company officials said their own similar analysis suggested a 31 percent greater risk information it shared with the FDA as early as 2005 but that more rigorous, although smaller, individual studies do not show that.