Tell the FDA to Reject the Panel's Advice on Avandia!

In 2010, the FDA required that the results of a controversial clinical study on Avandia be reexamined and re-adjudicated. Duke University did the re-adjudication and found that the risks for heart-related events were virtually the same as in the original study. Because these new results reaffirmed the drug manufacturer’s original findings, FDA advisory panelists voted to recommend removing or modifying Avandia’s highly restrictive label and distribution system—even though many world governments have banned the drug, and there is a great deal of evidence that it is extremely dangerous.

The FDA is not obligated to follow its advisory committee’s recommendation, though they usually do so. Moreover, there is no regulatory deadline by which they have to make a decision. If there is enough public pressure, perhaps this will force the FDA to reject the advisory committee’s decision on Avandia—or at least postpone any action indefinitely. Please send your message to the FDA about the dangers of Avandia.

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  • US Food and Drug Administration

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