FDA warning letter cites Glaxo's failure to disclose studies about Avandia health risks
GlaxoSmithKline, maker of Avandia, confirmed on April 8, 2008, that it has received a warning letter from the Food and Drug Administration related to Avandia, its diabetes drug.
The FDA said the drug giant failed to update the agency on more than 10 ongoing studies of Avandia, between 2001 and 2007, as required by federal regulations.
Concern over the safety of Avandia only reached the public in May 2007, when the New England Journal of Medicine published a combined analysis of more than 40 studies. That report, widely covered by mainstream media, found that Avandia significantly raised the risks of heart attacks.
If you or a loved one has suffered cardiac complications after ingesting Avandia, you deserve the guidance of a knowledgeable drug attorney. Get a free case review by filling out the form below.
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