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New FDA Safety Alert for Avandia (Rosiglitazone)


There's a new warning out by the FDA regarding the diabetes medication Avandia, generic name Rosiglitazone. Avandia is an anti-diabetic medication that increases the body's sensitivity to insulin in people who have Type 2 (Non-Insulin Dependent or Adult-Onset) Diabetes Mellitus. If you are taking Avandia now you probably already know this and may have heard the new warning all over the news but what does it mean to you?

Well let's start with the facts. Here is the actual warning, "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". This is where most of the reports on TV, etc stop, but it goes on to state that other studies, some of which have been published and some with publication still pending are showing contradicting results about the risks. The real issue here is weighing all the evidence objectively. Naturally, if a study shows no additional risk this doesn't make headlines but in the spirit of erring on the side of caution the FDA is issuing this warning so that people who use the medication can discuss with their healthcare providers what the best course of action for them is now. Also for healthcare providers to use caution in their prescribing practices.

What makes this so significant is that clinical trials done by the drugs manufacturer, GlaxoSmithKline, showed a 30-40% increase in the risk of heart attacks and other heart-related events in people who were using Avandia for 6-months when compared to those who weren't. The trials only lasted for 6 months so we don't know what the numbers are for those who have been on the medication for longer or shorter periods of time than that. Other than heart attacks, the other "heart-related events" include such things as fluid retention, congestive heart failure, and edema.

There is another drug in the same class as Avandia known as Actos (Pioglitazone), but it is not known at this time whether it poses the same, greater or less of a risk as Avandia for heart attacks or heart-related deaths. The FDA is not making this a Black Box warning, again because of conflicting studies and also because other clinical trials are currently being done to get more conclusive information.

The most important thing is that you NOT stop taking your medication without first discussing it with your healthcare provider and coming up with an alternative plan. There are problems associated with not taking your medication and also with switching to a different medication so this is not something you should even consider doing on your own.

ADDENDUM: 6/6/2007-FDA announced that The Endocrine and Metabolic Drugs and Drug Safety and Risk Management Committees will meet on July 30th 2007 to discuss the heart-related risks of Avandia and other anti-diabetic drugs in it's class.

Photo courtesy of kitchaboy
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The Healthline Editorial team writes about the latest health news, policy, and research.

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