Avandia, a Diabetic Drug, May Cause Heart Attack

Most of us may have heard this on the news some time last year. Nevertheless, I have decided to include it here for the benefits of those who have yet to hear about it. As can be seen in my blog dated February 21, new developments have already taken place concerning this drug subsequent to this alert. (A new safety alert by FDA was issued on August 14, 2007 regarding the potential danger of heart failure from consuming any of the thiazolidinedione class of antidiabetic drugs, of which Avandia is one.)

Avandia (rosiglitazone), approved in 1999 for treatment of Type 2 Diabetes, a serious and life-threatening disease suffered by some 18 to 20 million Americans, is potentially risky. Back in 2007, on May 21st, FDA issued an alert on the safety issues surrounding this drug. “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…Patients who are taking Avandia, especially those who are known to have underlying heart disease or who are at high risk of heart attack should talk to their doctor about this new information as they evaluate the available treatment options for their type 2 diabetes…there is inherent risk associated with switching patients with diabetes from one treatment to another even in the absence of specific risks associated with particular treatments. For these reasons, FDA is not asking GlaxoSmithKline, the drug's sponsor, to take any specific action at this time. FDA is providing this emerging information to prescribers so that they, and their patients, can make individualized treatment decisions.” said FDA.

According to FDA, “diabetes is a leading cause of coronary heart disease, blindness, kidney failure and limb amputation. Since the drug was approved, FDA has been monitoring several heart-related adverse events (e.g., fluid retention, edema and congestive heart failure) based on signals seen in previous controlled clinical trials of Avandia alone and in combination with other drugs, and from postmarketing reports. FDA has updated the product's labeling on several occasions to reflect these new data, most recently in 2006. The most recent labeling change for Avandia also included a new warning about a potential increase in heart attacks and heart-related chest pain in some individuals using Avandia. This new warning was based on the result of a controlled clinical trial in patients with existing congestive heart failure.”

FDA further wrote:

“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. These data, if confirmed, would be of significant concern since patients with diabetes are already at an increased risk of heart disease.”

Source:
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01636.html