|NEWS RELEASE||December 18, 2007|
Doctors Petition FDA for Additional Labeling Changes on Avandia
Labels Should Alert Patients That Diet Can Treat Diabetes Without Cardiac Risk, Group Says
WASHINGTON—Avandia’s labeling information should alert patients that diet can be a safer and more effective approach, says a petition to be filed with the Food and Drug Administration (FDA) today.
The petition comes just one month after the FDA called for a new black-box warning on Avandia, alerting patients to increased risk of heart attacks. The drug already included warnings of heart failure. Researchers estimate that Avandia (rosiglitazone) has caused more than 13,000 heart attacks and heart failure events in the United States alone.
The petition, filed by the Physicians Committee for Responsible Medicine, asks the FDA to require that Avandia and all drugs in its class include labeling that a low-fat vegan diet has been shown to be as effective or more effective than oral medications at lowering blood sugar in people with diabetes. The notice would also explain that a vegan diet can lower blood pressure and high cholesterol, and accelerate weight loss—as well as prevent and reverse heart disease. Avandia is part of the thiazolidinedione class of drugs.
“Given that people with diabetes are more likely to die of cardiovascular disease than any other health problem and Avandia appears to increase this risk, it’s crucial everyone taking the medication know there’s a safer option,” says PCRM president Neal Barnard, M.D. “A low-fat vegan diet is a proven—and surprisingly easy—way to control the disease.”
PCRM recently conducted a major clinical study testing the effects of a low-fat vegan diet in patients with type 2 diabetes. The study, funded by the National Institutes of Health and published in a journal of the American Diabetes Association, echoed previous studies showing the effectiveness of a plant-based diet as a treatment for type 2 diabetes.
Founded in 1985, the Physicians Committee for Responsible Medicine is a nonprofit health organization that promotes preventive medicine, conducts clinical research, and encourages higher standards for ethics and effectiveness in research.