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FDA Announces New Recommendations on Evaluating Cardiovascular Risk in Drugs Intended to Treat Type 2 Diabetes

Posted Dec 21 2008 10:21am

The U.S. Food and Drug Administration recommended today that manufacturers developing new drugs and biologics for type 2 diabetes provide evidence that the therapy will not increase the risk of such cardiovascular events as a heart attack. The recommendation is part of a new guidance for industry that applies to all diabetes drugs currently under development.

“We need to better understand the safety of new antidiabetic drugs. Therefore, companies should conduct a more thorough examination of their drugs’ cardiovascular risks during the product’s development stage,” said Mary Parks, M.D., director, Division of Metabolism and Endocrinology Products, Center for Drug Evaluation and Research (CDER), FDA. “FDA’s guidance outlines the agency’s recommendations for doing such an assessment.”

More than 23 million people in the United States have been diagnosed with type 2 diabetes or diabetes mellitus, a chronic metabolic disorder characterized by abnormally high blood sugar levels known as hyperglycemia.

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