FDA: Black Box Warning Label Decision Pending on Avandia Diabetes Drug

An announcement on the decision of whether to add a second black-box warning to the label of Avandia is pending, said the U.S. Food and Drug Administration (FDA) on November 14, 2007.

An agency advisory panel voted in June to keep the Type 2 diabetes drug on the market but opted also to include new warnings highlighting the increased heart attack risk.

The drug already carries a black box warning for heart failure. The new one for heart attack would indicate that it is less safe than its competitors, which don't carry that warning.

If you or a loved one has suffered cardiac complications after ingesting Avandia, you deserve the guidance of a knowledgeable drug attorney. Get a free case review by filling out the form below.

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News & Warnings

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