FDA Committee Recommends Avandia Stay on Market
Yesterday, a U.S. Food and Drug Administration advisory panel recommended in a 22 to 1 vote that FDA keep the controversial type 2 diabetes drug Avandia on the market. The panel also voted 20 to 3 that the drug does raise heart disease risk, however, and backed the requirement of a "black-box" warning on Avandia labeling. An estimated one million Americans currently use Avandia to control their diabetes.
In May, the New England Journal of Medicine published a controversial metanalysis of research examining Avandia and heart disease risk, setting off a significant debate in the diabetes community and Congress, and prompting the FDA to accelerate the committee hearing process on the drug.
While the panel's decision is considered a 'recommendation' to the FDA, the agency historically has followed its advice. However, CNN reports that there is disagreement within the FDA itself over the fate of the drug, quoting Dr. Robert Meyer, head of the FDA office that reviews new diabetes drugs, as telling the panel: "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." GlaxoSmithKline, the manufacturer of Avandia, continues to stand by the safety record of the drug.
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