Does Actos cause bladder cancer??

by Jay Watsky on July 17, 2011

Maybe.  Actos is a drug for treatment of diabetes that is clearly quite effective.  There has been information in the package insert about bladder tumors since 2006, so this question isn’t new.  However, there has been a lot in the lay press lately.  And, many ads from lawyers are popping up in the newspaper every day. 

In the original data on a few thousand patients submitted to the FDA there were 6 cases (0.16%) of bladder cancer in patients on Actos and 2 cases (0.05%) in those not on Actos.  There is an ongoing study to try to clarify the question of whether there is an association or not.  It is a 10 year epidemiological study by the University of Pennsylvania and Kaiser Permanente Northern California.  An interim analysis was published in Diabetes Care April 2011.  They reported that the association was not yet clear, but the study continues.  There does appear to be a possible increased risk for bladder cancer with long-term use of Actos, and this is an issue that will need to be monitored.  That risk is clearly small (0.03%) but further observation over time will be needed to tell if this risk is statistically significant or not.  If you are seeing reports of a 40% increase in risk (which does sound like a lot!) that is just a manipulation of the data to sound more scary.  If the risk exists at all it is an increase in number from 0.07% to 0.10%.  Yes, relatively speaking that is a 40% increase in risk, but again, the difference is only 0.03%.  That is a reasonably small number and the difference between groups could just be related to random chance. 

So, while we acknowlege that there may be a small risk, there is clear benefit to be gained from judicious use of this and other medications for control of diabetes.   It is certainly reasonable to discuss this concern with your physician.  In many cases the best option may be to continue this medication.  In others, there may be a better choice.  Please be sure to discuss this with your provider the next time you are here for a visit if this is a concern for you.

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