Perhaps you’ve heard about the recent controversy surrounding Avandia (rosiglitazone maleate), a medication used by nearly 1 million Americans to treat type 2 diabetes. Perhaps you’re even taking Avandia. If so, you may wish to consult with your doctor to confirm whether taking it is still the best option for you.
What’s going on?
A recent study published by the New England Journal of Medicine (May 21, 2007)[1] stated that diabetics who take Avandia have a 43% higher risk of heart attack when compared to diabetics who use other medications or no medications to control their diabetes. This finding is especially alarming when paired with the fact that diabetics already have an increased risk of heart problems. The authors of the study, Stephen E. Nissen, M.D. and Kathy Wolski, M.P.H., do present the possibility that the findings were due to chance, and that factors other than Avandia may have influenced the results of the study.
In response to this situation, the FDA reacted by issuing a safety alert regarding Avandia.[2] The FDA may also form an advisory panel to assess the situation, but at this time, there are no plans to change the current warnings on the packaging.
How safe is Avandia?
GlaxoSmithKline, the manufacturer, quickly responded to the NEJM study by issuing its own press release.[3] The company contends that the study has significant limitations and “incomplete evidence” to back up the claim that Avandia increases the risk of heart attack. In their statement, GlaxoSmithKline says that it is no more dangerous to diabetics than metformin or sulfonylurea (glyburide), two of the medicines that are most frequently used to treat diabetes.
Cited as evidence are the results of ADOPT, a study conducted by GlaxoSmithKline over a period of up to six years. The ADOPT study purports that any increase in risk of heart attack cannot be reliably attributed to Avandia, as the number of cardial incidents reported were minimal and could have been due to other factors. GlaxoSmithKline also points out that it has been shown to control blood sugar level for longer periods of time than other similar medications, thus making it an important medication to consider for the treatment of diabetes.
What should I do?
If you are taking Avandia or are considering taking Avandia to help control your diabetes, speak with your doctor about the medication and the risks it may pose for you before deciding on a course of action. Never take yourself off a medication without discussing it with your doctor first.
[1] Nissen, Steven E., Wolski, Kathy
Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes
N Engl J Med 2007 0: NEJMoa072761
[2] http://www.fda.gov/bbs/topics/NEWS/2007/NEW01636.html
[3] http://www.gsk.com/media/press-kits/avandia-21may2007.pdf
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