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FDA Places Significant Restrictions on Avandia

Today drug regulators in Europe and the FDA made a coordinated announcement regarding the fate of the diabetes drug, Avandia.  The joint announcement by European and United States regulators is very unusual.  

According to the announcement, Avandia sales in Europe will be completely suspended while the drug will only be made available to patients in the United States in very limited circumstances.  The decision by the FDA follows an intense advisory meeting in July of this year where a number of the experts on the panel recommended the drug be pulled from the market completely due to the increased risk of heart attacks and other serious side effects.

GlaxoSmithKline, the maker of Avandia, faces thousands of lawsuits on behalf of individuals who suffered heart attacks, congestive heart failure and strokes after taking Avandia.

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