By Steven Reinberg
Thursday, December 18, 2008 12:00 AM
WEDNESDAY, Dec. 17 (HealthDay News) -- The U.S. Food and Drug Administration is now asking all companies looking for approval of new type 2 diabetes medications to undertake studies that determine whether they cause cardiovascular problems.
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 guidance document will help industry evaluate the cardiovascular risk associated with new therapies under development to treat type 2 diabetes," Dr. Mary Parks, director of the Division of Metabolism and Endocrinology Products in FDA's Center for Drug Evaluation and Research said during a Wednesday afternoon teleconference.
Parks noted that diabetic patients are already at an increased risk for cardiovascular problems. But the agency believes it's important to insure that new drugs don't compound the risk further, she said. More than 23 million people in the United States have been diagnosed with type 2 diabetes.
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, Parks said.
Parks noted that these new requirements mean that companies will have to enroll more patients in clinical trails than in the past, especially more older patients who are already at risk for heart disease.
Trials assessing cardiovascular risks will have to go on for at least a year, Parks said. "The trials have to be of an adequate duration so that we can get a sense of long-term risk," she explained.
The change in the approval process does mean that it will take longer for new drugs to reach the market. "It's safe to assume that requiring a longer duration of trials, and a bolstering of the sample size, that it will add some years to the clinical development program," Parks said.
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, Parks said.
This guidance document does not affect drugs already on the market. These drugs will be the subject of another guidance document, Parks said. When that document will be released isn't known. "It's on our to-do list," she said.
For more information on diabetes, visit the U.S. National Institute on Diabetes and Kidney Diseases .
SOURCES: Dec. 17, 2008, teleconference with Mary Parks, M.D., director, Division of Metabolism and Endocrinology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration