Tuesday, February 23, 2010

Avandia to be withdrawn?

From Derek at In the Pipeline, it looks like leaks from a Senate report indicate that Avandia is about to be removed from the market. Thus ends a long run of pharmacoepidmeiology papers on the subject. It's not been an area that I worked in personally, but some of my friends have. Studying the heart risks of Avandia is tricky for observational data -- the disease being treated (diabetes) is a risk factor for the major side effect. This makes it very hard to separate disease and drug effects (especially since it is hard to control for severity and duration of a silent disease like diabetes).

But the existence of a comparator drug that showed a better risk profile for cardiovascular events was probably the decisive factor. Pharmacovigilance really can save lives!

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