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FDA Restricts Access to Avandia
Date:9/24/2010

By Steven Reinberg
HealthDay Reporter

THURSDAY, Sept. 23 (HealthDay News) -- In response to major concerns about heart risks, U.S. health officials on Thursday severely restricted use of the diabetes drug rosiglitazone (Avandia) to patients with type 2 diabetes who cannot control their disease on other medications.

U.S. Food and Drug Administration officials also ordered the drug's manufacturer, GlaxoSmithKline, to get an independent review of a key company-run trial of the drug's heart effects. And they pulled the plug on another company-run trial comparing Avandia to its competitor, pioglitazone (Actos).

"Because of concerns about cardiovascular safety, FDA is announcing regulatory action on medications containing rosiglitazone," FDA Commissioner Dr. Margaret A. Hamburg said during a morning press conference. "FDA is significantly restricting the use of these products by requiring the manufacturer to submit a Risk Evaluation and Mitigation Strategy [REMS]."

The FDA is requiring GlaxoSmithKline to develop a program that will restrict access to the drug to those patients for whom other treatments have not worked.

In addition, doctors will have to state and document a patient's eligibility to use Avandia. They will also have to tell patients about the cardiovascular safety risks associated with Avandia, and patients will have to acknowledge that they understand those risks.

Those currently using Avandia will be allowed to continue taking the drug, Hamburg said. However, once the REMS is in place these patients will also have to have their doctors justify use of the drug.

FDA officials believe this program will significantly reduce the number of people taking Avandia.

According to the agency, there was not enough evidence of Avandia's cardiovascular risks to pull the drug from the market, which is why it opted to restrict its use instead.

But in Europe, the European Medicines Agency h
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