GlaxoSmithKline Warned about Misleading Marketing in 2001
The Food and Drug Administration warned GlaxoSmithKline in 2001 that it needed to halt playing down the risk of heart attacks connected with taking Avandia, according to a Bloomberg News article ("U.S. FDA Warned Glaxo in 2001 About Avandia Marketing," May 24, 2007).
According to this report, a diabetes expert submitted a letter to the FDA a year earlier, airing concerns about Glaxo's perceived abuse of clinical trial data in regard to the cardiovascular safety of Avandia.
Following this warning, says Bloomberg, the FDA sent Glaxo a letter asking that its marketers stop denying or minimizing the increased risk of heart attacks and other cardiovascular events.
However, the article says, "Glaxo didn't notify doctors or patients of the possible increase in risks."
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Bloomberg News: FDA Warned Glaxo about Avandia Marketing in 2001