Possible Link Between Diabetes Drug Avandia and Heart Problems


What is the new information about Avandia (rosiglitazone)?

The U.S. Food and Drug Administration (FDA) is telling consumers about a possible increased risk of heart attack in individuals taking the drug Avandia (also called rosiglitazone) for type 2 diabetes compared with other treatment options. This information is very preliminary, and the FDA will continue to investigate whether an increased risk exists. The FDA has not withdrawn Avandia from the market and is not recommending that patients discontinue the drug at this time, as two ongoing studies contradict the findings of the clinical trials that indicate this possible risk.

Why is the FDA reporting this information?

A study was published in the May 2007 issue of the New England Journal of Medicine that combined the side effect data from 42 separate studies testing Avandia. This large review called a meta-analysis showed a possible small increase in the occurrence of heart attacks in the study groups that took Avandia as compared with the groups that took alternative medicines for diabetes.

While this type of study can offer important information, it usually cannot be used to prove causality. One of the reasons that the FDA is not withdrawing Avandia from the market at this time is that two other large studies contradict these clinical trials and do not show that Avandia increased the risk for heart attacks in diabetics.

The FDA has not confirmed the clinical significance of the possible increased risk in the context of other studies. Many questions about the purported risk remain, including whether the other approved treatment from the same class of drugs (pioglitazone) has the same or greater risks, or whether it is prudent for patients to change diabetes medications.

I take Avandia. Should I be concerned about heart problems, and what is my risk?

This warning is very preliminary, and there are many things we still do not know about possible risks to patients. The FDA will continue a scientific review of the drug, and we should know more in a few months. Despite the conflicting study results, many professional clinical associations - including the American Association of Clinical Endocrinologists, the American Diabetes Association, the American Heart Association and the American College of Cardiology - agree with the FDA's decision to warn patients about the possible risks of Avandia while allowing doctors to consider the information with their patients and make individualized treatment decisions.

Is there anything I can do to reduce my risk of heart attack?

Controlling your blood sugar is still the best proven way to reduce your risk of heart attack. Individuals with type 2 diabetes already have a 20.2 percent chance of a heart attack over a seven-year period, according to the American Diabetes Association. As a diabetic, there are several steps known as the ABCs that you can take to help lower your chance of having diabetes-related problems such as heart attack and stroke.

  • A is for A1c test, known as hemoglobin A1c (Acrobat), which should be done twice a year. It measures the average blood glucose over the last three months.

  • B is for blood pressure. Keeping your blood pressure below 120/80 decreases the amount of work on the heart and also reduces kidney problems.

  • C is for cholesterol. "Bad cholesterol," or LDL, clogs your blood vessels and increases your risk of heart disease. The LDL goal is less than 100 mg/ dl.

    The following are lifestyle choices you can make to help keep the ABCs of diabetes under control:

  • Lose weight and stay at a healthy weight by eating a diet low in fat, sugar, calories and carbohydrates, and high in fiber.

  • Exercise for 30 minutes most days a week to decrease insulin needs and to lower blood levels.

  • Take your medicine as ordered, and test your blood sugar levels.

  • Stop smoking to help improve your blood vessels and heart.

    For more information about controlling your diabetes, visit www.pamf.org/diabetes/healthinfo/diabetes.html.

    Where can I get more information about this warning?

    The best person to answer your questions is your doctor. Each patient's risks and health concerns are different. If you already have an appointment scheduled with your physician in the next four to six weeks, you may wish to speak with your doctor during this visit about appropriate medications and other treatment options for your type 2 diabetes. If you haven't already spoken to your physician, you may wish to make an appointment in the next six weeks to discuss this matter, particularly if you have heart disease or other cardiovascular conditions that put you at risk for heart attack.

    You may also get more information from the FDA Web site at www.fda.gov, or the American Diabetes Association's (ADA) Web site at www.diabetes.org to view a joint statement by the ADA, the American Heart Association and the American College of Cardiology.


    Back to top