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Major Heart, Diabetes Groups Urge Caution in Wake of Avandia Warning

Study raises concerns; Groups advise patients with diabetes to talk to their doctor

May 22, 2007 – The risk of heart attack and death for type 2 diabetes patients taking the drug Avandia “appears to be small”, but “must be considered carefully,” says a statement issued Monday by the American College of Cardiology, American Diabetes Association and American Heart Association. They advise patients using this drug should talk to their health care provider to determine the most appropriate course of action.

Finding of Increased Heart Attack, Death in Diabetes Patients from Avandia (rosiglitazone) Sparks FDA Alert

FDA issues immediate alert on the drug marketed as Avandia.

May 21, 2007 – Rosiglitazone, a drug widely used to treat type 2 diabetes, was found to significantly increase the risk of heart attacks and death from cardiovascular causes in a study of a wide range of data and clinical trials. The Food and Drug Administration immediately issued an alert on the drug marketed as Avandia. The study's authors also question the approval process used by the FDA for the approval of drugs to treat diabetes. Read More...

Today the New England Journal of Medicine published an article entitled, "Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes." The conclusions of this analysis of previous studies of rosiglitazone (brand name, Avandia) suggest that this oral agent used to treat type 2 diabetes may be associated with increased risk of heart attack and death from cardiovascular causes.

According to ACC, ADA and AHA, this study deserves serious thought and follow-up. As estimated here, the overall level of the risk associated with rosiglitazone appears to be small, but nonetheless one that must be considered carefully.

In the meantime, patients using this drug should talk to their health care provider to determine the most appropriate course of action. Patients should not stop taking any prescribed medications without first discussing the issue with their health care provider. Further research will be needed in this area to provide conclusive evidence.

It is very important to prevent diabetes when possible and to effectively treat it when it is present. The treatment of diabetes should be a team approach, with health care providers and patients working together to ensure patient education and empowerment.

The most life-threatening consequences of diabetes are heart disease and stroke, which strike people with diabetes more than twice as often as they do others. If you have diabetes, it is very important to control your blood glucose, blood pressure and cholesterol levels.

Information from the FDA for rosiglitazone can be found at: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01636.html.

About the American College of Cardiology:

The American College of Cardiology is leading the way to optimal cardiovascular care and disease prevention. The College is a 34,000-member nonprofit medical society and bestows the credential Fellow of the American College of Cardiology upon physicians who meet its stringent qualifications. The College is a leader in the formulation of health policy, standards and guidelines, and is a staunch supporter of cardiovascular research. The ACC provides professional education and operates national registries for the measurement and improvement of quality care.

About the American Diabetes Association

The American Diabetes Association is the nation's premier voluntary health organization supporting diabetes research, information and advocacy. Founded in 1940, the Association's mission is to prevent and cure diabetes and to improve the lives of all people affected by diabetes. The Association's commitment to research is reflected through its scientific meetings; education and provider recognition programs; and its Research Foundation and Nationwide Research Program, which fund breakthrough studies looking into the cure, prevention, and treatment of diabetes and its complications. Visit the American Diabetes Association at http://www.diabetes.org/ or call 1-800-DIABETES (1-800-342-2383).

About the American Heart Association:

Founded in 1924, the American Heart Association today is the nation's oldest and largest voluntary health organization dedicated to reducing disability and death from diseases of the heart and stroke. These diseases, America's No. 1 and No. 3 killers, and all other cardiovascular diseases claim over 870,000 lives a year. In fiscal year 2005-06 the association invested over $543 million in research, professional and public education, advocacy and community service programs to help all Americans live longer, healthier lives. To learn more, call 1-800-AHA-USA1 or visit http://www.americanheart.org/.

Source: American Diabetes Association

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