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July 20, 2010: Wall Street Journal Reports on Avandia Hearing

On July 14, 2010, an article in the Wall Street Journal reports that a U.S. Food and Drug Administration panel voted to recommend that GlaxoSmithKline PLC's (GSK) diabetes drug, Avandia, remain on the market despite concerns the product could raise the risk of heart attacks. Most panelists said the product should be subject to additional restrictions or used only if other diabetes drugs don't work, while many voted to allow the product to remain on the market with additional warnings and some sort of restricted distribution plan or additional doctor and patient education. The panel recommendations will be taken into consideration by the FDA, which will make the final decision about whether Avandia stays on the market. While several panel members said they had significant concerns about Avandia's safety, some said existing clinical data isn't strong enough to support removing Avandia from the market.   Avandia's safety has been in question since a 2007 article in the New England Journal of Medicine showed it raised  the risk of heart attacks by more than 40%. Heart failure from excess fluid retention has been a long-recognized problem with Avandia and the productsalready carries a boxed warning addressing that risk. The main issue with Avandia is whether it raises the risk of heart attacks and other cardiovascular problems more than other diabetes treatments.

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