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Avandia ® FDA News Release

Mar 10, 2011

FDA significantly restricts access to the diabetes drug Avandia

Makes regulatory decisions on RECORD and TIDE trials

The U.S. Food and Drug Administration today announced that it will significantly restrict the use of the diabetes drug Avandia (rosiglitazone) to patients with Type 2 diabetes who cannot control their diabetes on other medications. These new restrictions are in response to data that suggest an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia.

“The FDA is taking this action today to protect patients, after a careful effort to weigh benefits and risks,” said FDA Commissioner Margaret A. Hamburg, M.D. “We are seeking to strike the right balance to support clinical care.”

If you or someone you know has suffered from Avandia®, please contact us immediately by calling for a FREE Case Review.

Categories: Avandia

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