The US Food and Drug Administration (FDA) recommended in mid-December 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, MD, 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.”

The FDA also recommends that manufacturers have any cardiovascular events in their clinical trials analyzed by committees of outside cardiologists who are unaware of which patients received the tested products and which were on placebo. Based on these evaluations, the FDA can better ensure that product labeling includes comprehensive information on safety and effectiveness. This will enable prescribers and patients to make better-informed decisions on the management of type 2 diabetes.

"Diabetes Mellitus—Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes" is posted on the FDA’s Web site.

This article was published in Drug Discovery & Development magazine: Vol. 12, No. 1, January, 2009, p.20.