Diabetes News Alert: FDA Warnings About Actos And Bladder Cancer

by Cindy

Actos and Bladder Cancer

Bladder cancer is fourth most common type of cancer.  There are many different potential causes of bladder cancer that include smoking, chemical exposure, recurrent urinary tract infections and medications. Recently the diabetes medication pioglitazone, also known as Actos, has been investigated for a possible link to bladder cancer.

Pioglitazone (Actos) is a commonly used diabetes medication that in recent years has come under investigation after studies have shown there may be a small increase in the risk for developing bladder cancer in diabetic patients on this medication.  Recent studies have demonstrated that there may be a small increase in the incidence of bladder cancer in diabetic patients taking piolitazone (Actos) when compared to a control group.   This increase in risk was seen in patients taking pioglitazone (Actos) for longer periods of time. 

At this time, the research is still emerging from ongoing studies that have been extended into 10 year trials.  However, the studies have provided enough data for the European Medicines Agency and the U.S. Food and Drug Administration to take notice.  At this time, warnings exist for pioglitazone (Actos) advising physicians to exercise caution when prescribing this drug.  This medication has not been removed from the U.S. market and pioglitazone (Actos) is still a viable second or third line agent for the treatment of diabetes. 

According to FDA guidelines, pioglitazone (Actos) should be avoided in the following patient populations:

  • Patients with unexplained blood in their urine
  • Patients with active bladder cancer
  • Patients with a history of bladder cancer

This diabetes medication is still being carefully studied and it is important to know that it has not been removed from the U.S. market.  At this time, current recommendations advise physicians to prescribe this medication with caution in certain patient populations.  As more data emerge, the regulatory agencies will be better prepared to make further recommendations about this use of this diabetes medication.

For more complete information check out the FDA Drug Safety Communication here.


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