After reviewing the latest research, the FDA is reaffirming its warning that use of the type 2 diabetes drug pioglitazone might increase the risk of bladder cancer.

Pioglitazone-containing medications (such as Actos, Actoplus Met, Actoplus Met XR, Duetact, and Oseni) have noted the possible risk on their drug labels since August 2011. Now the FDA has added recent study findings.

The agency warned about the possible link to bladder cancer in September 2010 and June 2011 after assessing interim findings from a 10-year epidemiologic study by the manufacturer. Although final results of the 10-year study did not find an increased risk of bladder cancer with pioglitazone, another study did. The FDA noted that the PROactive (PROspective pioglitAzone Clinical Trial In macroVascular Events) trial found an increased risk during the trial period. Findings from other studies have been mixed and have probed the possible effects of drug dose and duration of use. A recent study Marco Tuccori and colleagues published in the BMJ (2016;352:i1541) found a 63% increased risk of bladder cancer associated with pioglitazone use.

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The FDA states that healthcare providers should not prescribe pioglitazone, a thiazolidinedione drug, to patients with active bladder cancer, and should weigh the risks before recommending it to those with a history of bladder cancer. Healthcare professionals are encouraged to report side effects to the FDA MedWatch program.

Patients starting pioglitazone should be alerted to possible signs of bladder cancer, such as blood in the urine, new or worsening urinary urgency, and pain with urination.


1. FDA Drug Safety Communication: Updated FDA review concludes that use of type 2 diabetes medicine pioglitazone may be linked to an increased risk of bladder cancer [press release]. FDA; December 12, 2016.