Avandia | Type 2 Diabetes Drug

Manufactured by GlaxoSmithKline, Avandia (generic name rosiglitazone) is a commonly prescribed drug used to treat Type 2 Diabetes. On May 21, 2007, the Food and Drug Administration (FDA) issued a safety alert for Avandia. In this alert, the FDA stated that "Recently, the manufacturer of Avandia provided FDA with a pooled analysis (meta analysis) of 42 randomized, controlled clinical trials in which Avandia was compared to either placebo or other anti-diabetic therapies in patients with type 2 diabetes. The pooled analysis suggested that patients receiving short-term (most studies were 6-months duration) treatment with Avandia may have a 30-40 percent greater risk of heart attack and other heart-related adverse events than patients treated with placebo or other anti-diabetic therapy. This data, if confirmed, would be of significant concern since patients with diabetes are already at an increased risk of heart disease."

The FDA will soon hold advisory panel meetings on the dangers of Avandia. This panel's recommendations could result in several possible courses of action, including a black box warning on the Avandia label (the FDA's strongest warning), limitations on who can be prescribed Avandia, a total recall of Avandia or no action whatsoever.

In its June 14th issue, the New England Journal of Medicine published an article on the effect of Avandia (rosiglitazone) on the risk of myocardial infarction and death from cardiovascular causes. The article reported problems regarding Avandia's side effects, based on an independent meta-analysis. This study was conducted by Kathy Wolski, M.P.H. and Steven Nissen, M.D, a renowned cardiologist from the Cleveland Clinic. Dr. Nissen had previously published a study on problems with the arthritis drug Vioxx, which was then recalled in 2004.

The study evaluated 42 trials that compared patients taking Avandia with those who weren't. The total study involved 28,000 patients, of which 15,560 were taking Avandia. Of the patients who took Avandia, 86 suffered heart attacks, as compared to 72 patients not taking the drug. Additionally, another 39 patients died from cardiovascular causes compared to 22 patients not taking Avandia.

The authors of the study indicated that these new findings are "worrisome" because of the high incidence of cardiovascular events in patients with diabetes. According to the authors, "Because exposure of such patients to rosiglitazone is widespread, the public health impact of an increase in cardiovascular risk could be substantial if our data are borne out by further analysis and the results of larger controlled trials."

Worldwide, more than 6 million people have used Avandia to help control blood sugar in people with Type 2 Diabetes. Approximately 1 million Americans are prescribed Avandia. However, since the onslaught of information about Avandia's risks, many doctors have quit prescribing Avandia in favor of alternative drugs considered to be safer. In fact, following the release of the article in the New England Journal of Medicine, the number of new prescriptions for Avandia dropped by 40%.

Based on the significant research available, Avandia has been linked to an increased risk of serious injuries and possible death due to heart attacks, strokes and heart failure. If you or someone you care about has taken Avandia and suffered serious side effects as a result, please fill out our Case Review Contact Form to the right on this page to find out what your case is worth.