Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

While an expert panel in the U.S. reviews evidence to decide whether to pull the popular diabetes drug Avandia off the market due to an increased risk of cardiovascular events, BusinessWeek reports that the drug’s maker, GlaxoSmithKline (GSK), has agreed to pay about $460 million to settle lawsuits alleging the company hid evidence that Avandia increased the risk of heart attacks and strokes. GSK faces more than 13,000 lawsuits and has agreed to settle about 10,000 of them. Avandia was to face its first trial in federal court in October. BusinessWeek reports that the FDA review helped prompt the company’s decision to settle the suits.

Avandia was approved by the Food and Drug Administration (FDA) in 1999 to treat Type 2 diabetes, the fastest growing form of diabetes. GSK launched a multimillion-dollar ad campaign to introduce the drug to the market, which brought in $1 billion in sales last year alone with more than 2 million prescriptions filled.

A 2007 study found that Avandia could increase the risk of heart attack by as much as 43 percent, and more recent studies suggest that Avandia may be responsible for thousands of cardiovascular events such as heart attacks, strokes and other heart problems. In 2007, an FDA panel reviewed the data but voted not to pull the drug off the market.

However, concerns over a new study on the drug has led the FDA to conduct a second review the safety of Avandia. The agency is also questioning whether GSK tried to cover up the risks associated with the drug.

The panel is expected to vote soon on whether to remove the popular diabetes drug from the market.

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