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Avandia Label to Get Heart-Attack Warning
Date:11/14/2007

rsen heart failure -- a condition in which the heart does not adequately pump blood -- in some patients. The association between Avandia and increased risk for heart failure has been known since 1999, when the drug was first approved.

Woodcock noted that Avandia and the other oral anti-diabetes drugs, called thiazolidinediones, have not been shown to prevent cardiovascular risk as a byproduct of reducing blood sugar.

In light of this, the FDA is asking all manufacturers of approved oral anti-diabetes drugs to include a statement on their label saying that there is no data that the drugs have the ability to protect the heart.

More information

For more on diabetes drugs, visit the U.S. Food and Drug Administration.



SOURCES: Nov. 14, 2007, teleconference with Janet Woodcock, M.D., acting director, Center for Drug Evaluation and Research, U.S. Food and Drug Administration; Nov. 14, 2007, news release, GlaxoSmithKline, Philadelphia


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