FDA's Final Word on Avandia

  • by: |
  • 11/14/2007
Forget the black box for now..here's FDA's Janet Woodcock speaking clearly and confidently on what the agency decided and what the new labeling means:

"We are keeping Avandia on the market because we have concluded that there is not enough evidence to conclude that the risk for heart attack or cardiac ischemia is higher than for other type-2 diabetes drugs," the FDA's Dr. Janet Woodcock told reporters in a phone briefing.

The studies have been inconclusive and those that appear to show a risk all compare Avandia to a placebo, she said."

Thus the FDA is closer to the European Medicine Agency than Canada. I am keeping a count to see how many news accounts or blogs note that the EMEA kept Avandia on the market without relabeling. Big zero so far.

http://www.reuters.com/article/governmentFilingsNews/idUSN1421392120071114
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Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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