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Type II diabetes is a serious and life threatening disease that affects about 18 to 20 million Americans. Diabetes is the leading cause of coronary heart disease, blindness, kidney failure and limb amputation. Avandia (rosiglitazone) is an oral anti-diabetic agent, first approved in 1999, for type II diabetes. It does not cause the body to make more insulin but instead helps the body use its own insulin.

Recently there has been a storm brewing regarding the safety of Avandia (rosiglitazone). An article published in the New England Journal of Medicine has claimed that patients on Avandia (rosiglitazone) were susceptible to myocardial infarction or death after relatively short-term exposure. The article that is causing all of the attention is titled “Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes” This article has cited a concern based on analyzed data that when comparing Avandia (rosiglitazone) to placebo and other anti-diabetic medications, there was a significant increase in the amount of myocardial infarction and an increase in the risk of death from cardiovascular causes that were borderline statistically significant. The American College of Cardiology, American Diabetes Association and American Heart Association listed a joint statement stating that this study deserves serious thought and further follow up. This is partially because the analysis used was on available data from publicly disclosed summaries of events. Further, the results were gathered from groups of studies that did not have as a part of their original intent to look at possible cardiovascular side effects.

On May 21, 2007, the Food and Drug Administration issued a letter notifying the public of their awareness of a potential safety issue with Avandia (rosiglitazone). In their letter they stated 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 (rosiglitazone).” Their letter does go on to state that there has been other studies regarding Avandia (rosiglitazone) that have had the opposite results. The Food and Drug Administration is not asking the manufacturer GlaxoSmithKline to take any specific action at this time with one of their cited reasons being the inherent risk associated with switching patients with diabetes from one treatment regimen to another. In 2006, the FDA did request that the manufacturer make a labeling change about warning consumers about a potential increase in heart attacks and related chest pains in some individuals who use Avandia (rosiglitazone). This warning label change was based on a recent controlled clinical trial involving patients who had pre-existing congestive heart failure.

The next steps regarding these findings by all parties have been to call for future studies that will specifically look for potential side effects. There has been a call for the FDA to re-evaluate the way in which they approve anti-diabetic medications. Currently a sustained reduction in blood glucose levels with an acceptable safety profile sufficient for approval of anti-diabetic patients. Critics of this policy would like to see a shift that calls for approval based on reduction of the complications of diabetics not just lab results that look at glycemic index numbers.

References:

Nissen SE and Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med 2007; DOI:10.1056/NEJMoa072761. Available at: http://www.nejm.org

Psaty B and Furberg C. Rosiglitazone and cardiovascular risk. N Engl J Med 2007; DOI:10.1056/NEJMe078099. Available at: http://www.nejm.org

American Diabetes Association. Statement from the American College of Cardiology, American Diabetes Association and American Heart Association Related to NEJM article, “Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes’. Retrieved May 2007 from: http://www.diabetes.org/diabetesnewsarticle.jsp?

U.S. Food and Drug Administration. FDA Issues Safety Alert of Avandia. Retrieved May 2007 from: http://www.fda.gov.bbs/topics/NEWS/2007/NEW01636.html

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