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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