On November 14, 2007, the FDA added a new black box warning to GlaxoSmithKline's diabetes drug Avandia, about a potential increased risk of heart attacks, in addition to the black box warning that was added in August 2007, about the increased risk of heart failure.
The FDA said the new warning would also apply to Glaxo's diabetes drugs Avandamet and Avandaryl, since they both contain the same active ingredient as Avandia. However, Senator Chuck Grassley (R-Iowa), ranking member of the Senate Finance Committee, has asked the FDA to respond to accounts that on October 2, 2007, the agency convened a drug safety oversight board that voted to keep Avandia on the market by a one-vote margin amid considerations of a second warning.
In an October 26, 2007 letter to FDA Commissioner Andrew von Eschenbach he is also asking about the terms and conditions governing public notification with this sort of information.
"The Avandia case continues to present new rounds of questions about the way the FDA monitors and assesses drug risks and decides whether to let the public know about emerging risks," Senator Grassley said in an October 29, 2007 press release.
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