Sunday, June 03, 2012

Avandia FDA Advisory Committee Reviews Avandia Warnings

By Dr. Bill Quick, Health Pro Sunday, July 18, 2010

 

I think that it's likely that the FDA will soon ask the manufacturer to withdraw Avandia. It made a similar request about another glitazone, Rezulin (troglitazone), a drug which was found to have liver toxicity. In that case, the FDA pointed out that there were other glitazones available (Avandia and Actos) that did not share the liver problem, and that Rezulin had no niche where it was more efficacious than the other glitazones. It would be easy for the FDA to claim that Avandia is another "outmoded drug," as it decided Rezulin was back in 2000. After all, there is another glitazone available (Actos) that does not share the cardiovascular problem, and Avandia has no niche where it is more efficacious than the other glitazone. And there are new classes of drugs for type 2 diabetes that didn't exist when the glitazones were approved, so patients could be transferred to Actos or other classes of diabetes drugs.

For those of you taking Avandia, a reminder of what I've previously said: If you have no history of heart disease or stroke, and have no risk factors such as hypertension or smoking, and if it is clear that Avandia is helping to control your glucose levels, there's no rush to change from Avandia to any other diabetes medication. Your doctor and you can decide whether to switch to the other drug in the same class as Avandia (Actos, AKA pioglitazone) or perhaps try treating your diabetes without glitazones.


If you are on Avandia, have no history of heart disease, and it is not helping to control your glucose levels, you probably should be switching to another diabetes medication, or adding insulin therapy. There are numerous other oral diabetes drugs that could be tried, and insulin always works (maybe it's time for you to start insulin therapy!) - you should discuss all the options with your diabetes team.


If you are on Avandia, and have a history of heart disease or stroke, you should already have advised to switch from Avandia to another diabetes treatment. Hints about Avandia's increased risk has been out there for over two years, and there are now several studies that imply that staying on this drug is increasing your risk of more heart problems. You should talk to your physician about switching as soon as convenient - and I wouldn't wait for your next appointment if it's many months away.


Finally, if you are on Avandia, do not stop taking it just because of the adverse publicity. Talk things over with your diabetes team about what options you have.

 

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By Dr. Bill Quick, Health Pro— Last Modified: 05/03/11, First Published: 07/18/10