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

The fate of the diabetes drug Avandia will likely be decided soon by an expert panel that has spent the past two days reviewing evidence that linked the drug to serious cardiovascular events and whether its developer and manufacturer, GlaxoSmithKline (GSK), influenced the results of a study asserting the safety of Avandia.

Avandia, also known by the generic name rosiglitazone, faced the same panel in 2007, which voted 22-1 to keep the drug on the market despite a separate vote of 20-3 that there probably was a link to heart problems. Since then, several publications have come out both in support of and against the safety of Avandia. One major topic of this second go-round with the panel includes an analysis of the RECORD study, which the Food and Drug Administration’s Dr. Thomas Marciniak of the division of cardiovascular and renal products wrote, “was inadequately designed and conducted to provide any reassurance about the (cardiovascular) safety of rosiglitazone.”

The 5 ½-year RECORD study involved nearly 5,000 diabetes patients and showed that the drug was not related to an increase in cardiovascular events other than congestive heart failure, which is a documented side effect of drugs used to treat diabetes.

Avandia is a blockbuster medication approved in 1999 to treat Type 2 diabetes, the most common form of the disease. More than a million people in the U.S. have taken the drug. Studies have concluded that Avandia raised the risk of heart attacks in people who used the drug by as much as 43 percent compared to people taking no diabetes medication or other diabetes drugs. Studies have also indicated that Avandia might increase the risk of heart-related deaths.

However, GSK backs the RECORD study, which the FDA argues is “inappropriate and biased.” The panel is expected to vote soon whether to pull the popular diabetes drug off the market.

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