Avandia's New Label

The New York Times this morning ran an account of yesterday's House hearing that may confuse some readers. The labeling change on Avandia revealed yesterday by Food and Drug Administration officials warns about the long-known side effects of this class of diabetes drugs (Avandia and Actos): they cause weight gain and water retention, which can lead to congestive heart failure.

This is very different from the risk of sudden heart attacks and strokes associated with Avandia use, which was the subject of the New England Journal of Medicine meta-analysis by Steven Nissen and will go before an FDA advisory committee meeting on July 30th. The agency still hasn't decided where it stands on that issue.