Avandia (generically known as rosiglitazone) is a form of thiazolidinedione drug commonly used to lower blood glucose levels in patients with type 2 diabetes. Thiazolideinesdiones, prescribed in normal doses, decrease glycated hemoglobin levels by an average of about 1 one percentage point or less. Although thiazolideinesdiones may be beneficial in this regard, they have been linked to increases in body weight, adverse effects on lipids, fluid retention and anemia. Rosiglitazone is used either alone or in combination with other anti-diabetic medications such as metformin, sulfonylureas or insulin.

In short term trials, Avandia has proven to be effective at reversing insulin resistance, reducing levels of fasting glucose and glycated hemoglobin. The drug which is manufactured by GlaxoSmithKline was approved in 1999 for the treatment of hyperglycemia in type 2 diabetes. Since Avandia’s approval the Food and Drug Administration has monitored heart related side effects of the drug such as fluid retention, edema and congestive heart failure. Although the FDA has monitored the heart related side effects of the drug since its approval, a recent study performed by Steven E. Nissen, M.D., and Kathy Wolski, M.P.H. revealed startling results.

The study published online on May 21, 2007, in the New England Journal of Medicine concluded that “as compared with placebo or with other antidiabetic regimens, treatment with rosiglitazone is associated with a significant increase in the risk of myocardial infarction (heart attack) and with an increase in the risk of death from cardiovascular causes that was of borderline significance.” This meta-analysis, based upon available data, analyzed the results of 42 previous studies of Avandia involving 27,843 participants. Despite the limitations of the study, Dr. Nissen found that patients taking Avandia had a 43% higher risk of suffering from heart attacks. The study also produced evidence of elevated rates of cardiovascular death in patients taking Avandia. These results are cause for concern, since patients with type 2 diabetes already have a high risk of cardiovascular disease.

An accompanying editorial written by Bruce M. Psaty, M.D., Ph.D., and Curt D. Furberg, M.D., Ph.D. stated that “in view of the potential cardiovascular risks and in the absence of other health advantages, except for laboratory measures of glycemic control, the rationale for prescribing rosiglitazone at this time is unclear.” “Unless new data provide a different picture of the risk-benefit profile, regulatory action by the Food and Drug Administration (FDA) is now warranted.”

On May 21, 2007, the same day Dr. Nissen’s study was published online in the New England Journal of Medicine, the FDA issued a safety alert on Avandia. The FDA acknowledged that “safety data from controlled clinical trials have shown that there is a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia,” but further stated that “other published and unpublished data from long term clinical trials provide contradictory results.” To date, the FDA has not confirmed the clinical significance of the reported increased risk in Dr. Nissen’s study.

On May 23, 2007, the FDA issued a request that a black box warning be placed on Avandia. A “black box” warning is required when medical studies indicate that the drug carries a significant risk of serious or even life-threatening adverse effects and is the most serious warning a drug label can bear. The FDA has emphasized that if patients using Avandia experience concerns about their health as a result of the recent studies and findings, they should discuss them with their physicians and not unilaterally stop taking the medication.