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WASHINGTON – The widely used diabetes drug Avandia should be pulled off the market, U.S. federal health officials said Monday, urging action in response to studies linking the drug to an increased risk of heart attacks.
That risk, combined with the drug's lack of unique short-term benefits in helping diabetics control blood sugar, means continued sales are not justified, Food and Drug Administration scientist Dr. David Graham told a panel of outside experts.
"It is important that the committee understand there is a fundamental disagreement within (the FDA's drugs office) on the scientific conclusions that should be drawn," said Dr. Robert Meyer, head of the FDA office that reviews new diabetes drugs.
That split exposed a rift between officials charged with approving new medicines and those who monitor their safety once on the market.
Congress has pointed to Avandia as evidence of FDA's fumbling of safety problems that emerge long after drugs win agency approval. The House and Senate are at work on legislation to overhaul the FDA.