Wednesday, September 22, 2010

Pioglitazone (Actos) under FDA review

The FDA is now reviewing pioglitazone (Actos), a popular drug for the treatment of diabetes, for a possible link to bladder cancer.  Pioglitazone has been gaining in popularity after a rival drug, rosiglitazone (Avandia), had been shown to increase cardiovascular risk.  Pioglitazone sales top $3 billion annually, while rosiglitazone has fallen to less than $600 million annually due to the negative data on myocardial ischemia.    

So far, the FDA is not recommending discontinuation of pioglitazone, as the association with bladder cancer comes from an interim analysis of a 10-year study being performed by the drug's manufacturer, Takeda.

The entire drug class of TZDs has come under increasing scrutiny over safety.  I am beginning to think that the entire class of medication should be avoided and other means of controlling hyperglycemia in diabetics should be pursued.

Will be interesting to see what future data will reveal about pioglitazone.

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