The U.S. Food and Drug Administration has asked all companies to show their diabetes drugs don’t increase chances of cardiac trouble. This new guidance document, announced Wednesday, comes on the heels of reports that two commonly prescribed blood sugar-lowering drugs already on the market, Avandia and Actos, increase the risk of heart failure and, in the case of Avandia, increase the risk of heart attack.
The new guidance reflects the decision of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee, which in July called for studies of the cardiovascular risks of new diabetic drugs. According to the new guidance, companies looking to have new diabetes drugs approved by the FDA must submit data from phase II and phase III trials that show these drugs are not associated with an “unacceptable risk” of cardiovascular disease.
The FDA has sent 100 to 150 letters to companies with new diabetes products under development to alert them of the new guidance, which takes effect immediately.