FDA ALERT [8/2007]: This Alert highlights important revisions to the full prescribing information for rosiglitazone maleate (marketed as Avandia, Avandamet, and Avandaryl). The updated information includes a new BOXED WARNING, and additional updated WARNINGS, PRECAUTIONS and CONTRAINDICATIONS to emphasize that rosiglitazone may cause or exacerbate heart failure, particularly in certain patient populations. The implications of this new labeling for healthcare professionals who prescribe Avandia, Avandamet, and Avandaryl are summarized below. This information reflects FDA’s current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available.
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Not a surprise; this side effect is well-known for both of these drugs. Although laypeople often confuse heart failure and heart attacks, they are distinct. Heart failure is when the heart is chronically weak; heart attacks are when muscle tissue in the heart actually dies because it is starved of blood. So this is not the denouement of the Avandia controversy we've been watching for several months now. --Matt Herper
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