October 24, 2007
FDA Pushes For Avandia Black Box Warning
Posted at October 24, 2007 2:34 PM in .
Citing the risk for heart attacks, the FDA is pushing Glaxo Smith Kline, the maker of Avandia, to put the strongest possible warning on its Avandia labels. Avandia already carries a black box warning for heart failure. The new warning would be more serious in that it would warn doctors and consumers about the potential risk for heart attacks. An FDA analysis of multiple studies found that Avandia poses a 38% increase in the risk of ischemic incidents. An ischemic event occurs when blood flow is cut off from the heart resulting in subsequent heart attacks.
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