FDA Adds to Boxed Warning for Drug Avandia

On November 14, 2007, the U.S. Food and Drug Administration announced that GlaxoSmithKline, the manufacturer of Avandia (rosiglitazone) which is a drug used to treat type II diabetes, has agreed to add new information to the existing boxed warning on the drug’s labeling. Rosiglitazone belongs to a class of drugs called thiazolidinediones. Thiazolidinediones are a class of diabetic drugs that attach within the cell to receptors to decrease insulin resistance. The boxed warning is the strongest form of warning issued by the FDA. The previous revision to the boxed warning on Avandia was issued on August 14, 2007. It called attention to the fact that these types of drugs may worsen heart failure in some patients.

The revision on Avandia’s labeling includes the follow statement; “A meta-analysis of 42 clinical studies(mean duration 6 months; 14,237 total patients), most of which compared Avandia to a placebo, showed Avandia to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction. Three other studies (mean duration 41 months; 14,067 patients) that compared Avandia to some other approved oral anti-diabetic agents or placebo have not confirmed or excluded this risk. In their entirety, the available data on the risk of myocardial ischemia is inconclusive.

The statement released by the FDA does point out that there isn’t enough evidence to indicate that the risks of heart attack or death are different between Avandia and some other type II diabetic treatments. Because of that, the FDA has requested that GlaxoKlineSmith conduct a new long-term study to evaluate the potential cardiovascular risk of Avandia in comparison to an active control agent. The new warning follows the recommendations made at the joint meeting of the FDA’s Endocrine and Metabolic Drugs and Drug Safety and Risk Management Advisory Committee. At that meeting, the combined committee members decided that Avandia should not at this time be pulled off of the shelf pending review of additional data. The committee also advised that information warning of the potential for increased risk of heart attacks be added to the drug labeling.

Diabetes affects a large part of the population. Therefore, if you have a client or family who needs representation due to a cardiac complication, an assessment of the diabetic patient’s status may provide helpful insight. The consensus statements of the ADA and AHA recommended that patients with moderate to severe congestive heart failure should not take thiazolidinediones. The statement goes on to specifically describe how this group of medications should be prescribed, adjusted and potential side effects monitored by healthcare practitioners. Specifically, the statement advises patients who have greater than a six pound weight gain, sudden onset of swollen feet, shortness of breath or fatigue to contact their physicians immediately.

Please see our website for more information on Avandia and other thiazolidinediones, and contact our office if you have a case that involves these medications.

References:

U.S. Food and Drug Administration. FDA News: FDA Adds Boxed Warning for Heart-related Risks to Anti-Diabetes Drug Avandia. Retrieved November 2007 from www.fda.gov/bbs/topics/NEWS/2007/NEW01636.html.

American Heart Association.(2003) AHA/ADA issue statement guiding doctors use on TZDs. Retrieved August 2007 from www.americanheart.org.