FDA Divided Over Controversial T2 Diabetes Drug Avandia
By Mike Boyle


Faced with thousands of lawsuits regarding the safety of its controversial type 2 diabetes drug Avandia (rosiglitazone), British drugmaker GlaxoSmithKline breathed a sigh of relief of Wednesday (July14) when a majority of a Food and Drug Administration (FDA) advisory panel voted to recommend that the drug remain on the market - but with tighter supervision and warnings about the danger of heart attacks.

Of the panel’s members, 12 voted that Avandia should be withdrawn; 10 voted that its sales should be restricted and the warnings on its label enhanced; seven voted only to support enhanced warnings on the drug’s label; and three voted that the drug should continue to be sold with its present warnings unchanged.

A final decision on the FDA`s position on Avandia will be made by the Administration`s Commissioner, Margaret A. Hamburg, but that decision isn`t expected for several weeks.

Quoted in the The Washington Post, Sen. Charles E. Grassley (R-Iowa), who has been investigating Avandia , said, "Any action taken by the FDA after this vote, and after the agency`s record with this drug, will be closely watched by physicians and patients who need to feel confident that the FDA has put science and safety first."

And if you are a concerned user of  Avandia, CNN offers some options.



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Originally posted by DiabetesCare.net on July 15, 2010.