FDA Divided Over Controversial T2 Diabetes Drug AvandiaThursday, July 15, 2010
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Of the panel’s members, 12 voted that Avandia should be withdrawn; 10 voted that its sales should be restricted and the warnings on its label enhanced; seven voted only to support enhanced warnings on the drug’s label; and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.