FDA asks diabetes drug makers to prove treatments won’t increase risks to heart health

12/17/2008

ROCKVILLE, Md. Manufacturers of drugs and biologics for treating Type 2 diabetes should include evidence that the treatments will not increase the risk of heart attacks and other cardiovascular disease, the Food and Drug Administration announced Wednesday.

More than 23 million people in the United States have diagnosed Type 2, or adult-onset, diabetes. Patients with diabetes have twice to four times the risk of heart disease, compared to those without it, and no approved therapies for diabetes have been proven to reduce the risk, the FDA said.

“We need to better understand the safety of new anti-diabetic drugs,” director of the Division of Metabolism and Endocrinology Products at the FDA’s Center for Drug Evaluation and Research Mary Parks said in a statement. “Therefore, companies should conduct a more thorough examination of their drugs’ cardiovascular risks during the product’s development stage.”

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