Sunday, July 18, 2010

Florida/Georgia Avandia News: Restrict, but don't Recall Avandia

Avandia survives another round of FDA meetings. An FDA panel  panel took six votes on a variety of issues, but its most important came near the end of the meeting when asked what the FDA should do. Sales should be restricted and the warnings on its label enhanced; 7 voted only to support enhanced warnings on the drug’s label; and 3 voted that the drug should continue to be sold with its present warnings unchanged. One member abstained, and no one voted for a final option, to weaken the label’s present heart warnings.

Avandia, which was once the biggest-selling diabetes medicine in the world, saw its sales abruptly decline in 2007 after a study by Dr. Steven Nissen, a Cleveland Clinic cardiologist, found that it increased the risk of heart attacks. An advisory committee in 2007 decided that Avandia did increase heart risks but voted to keep it on the market.

Many of the same experts who decided to keep the drug on the market in 2007 voted Wednesday that it should be withdrawn or restricted. Those restrictions could mean that patients would have to apply for special permission to use the drug.

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