DGIM Statement on Avandia

Dear patients,

You have probably heard the recent news reports about the drug Avandia (rosiglitazone). Avandia is one of many drugs used to control blood sugar in people who have diabetes. Avandia has been available since 1999, and if you are currently taking Avandia, you may now have questions about the long-term safety of this drug.

To summarize what was reported, Avandia was linked to an increase in heart attack risk in a study that pulled together 42 separate clinical studies involving Avandia. The results show that Avandia may increase the risk of a heart attack by 43 percent compared to other diabetes drugs or no treatment at all. The overall risk for an individual patient was rather low in this analysis, as only 87 patients out of more than 25,000 had heart attacks who were taking Avandia versus 72 patients not taking Avandia. This is such a small number that the true impact of this possible effect may not be very meaningful.

Please note that in general, patients with diabetes are at higher risk of heart attack than patients without diabetes, and patients often have other factors (high blood pressure, high cholesterol, inactive lifestyle, smoking) can also increase the risk of heart attack. With all of these factors, it is very hard to know if it was Avandia that increased a patients’ risk of heart attack, or if it was one of these other factors.

To this point, there are several large ongoing medical studies of Avandia that have been designed specifically to look at increase risk of heart attack in patients taking Avandia. Thus far in these studies, no increase in risk in heart attacks in patients taking Avandia has been shown. The Food and Drug Administration (FDA) and the National Institutes of Health (NIH) have monitored these large trials from a safety perspective without any cause for concern. Several prominent medical organizations, including the American Diabetes Association, the American Heart Association, the Endocrine Society, and other medical groups have indicated that, while more research is needed, there is no reason to recommend that patients stop therapy with Avandia at this time.

We at Duke General Internal Medicine are committed to excellent care of our patients and want to help keep you informed. We encourage you to speak with your doctor about concerns you may have about Avandia use. Only you and your doctor should decide what to do with your Avandia therapy. However, we do not consider there to be any immediate health threat to patients by continuing to use Avandia. You should not stop your Avandia suddenly without speaking with your doctor first. Stopping Avandia without your doctor’s help could lead to dangerously high blood glucose values, which could be harmful to you.

Thank you for allowing Duke General Internal Medicine to continue to help you with your medical needs and concerns, and best wishes for continued good health.