FDA and European Regulators Severely Restrict Access To Avandia


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FDA and European Regulators Severely Restrict Access To Avandia

Submitted by Diane DeNooyer on Thu, 09/23/2010 - 12:17

Avandia

In an almost unprecedented joint announcement, the FDA and European regulators announced that access to Avandia, a medication to treat diabetes marketed by GlaxoSmithKline, will be severely restricted.

Sales of Avandia in Europe will be suspended. However in the United States the FDA will allow patients to receive Avandia only if they have tried every other diabetes medicine and have been made aware of the drug's substantial risks to the heart.

Sales of Avandia are expected to plummet. Avandia has been a subject of thousands of lawsuits filed by victims who claim heart problems as a result of its use. GSK has reported the settlement of hundreds of claims, many more may now be filed.