Does Pioglitazone Increase Bladder Cancer Risk?

The US Food and Drug Administration (FDA) still has concerns that the type 2 diabetes drug Actos (pioglitazone; Takeda Pharmaceuticals) may increase risk for bladder cancer after an updated review of published research.

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A 2011 review of the drug revealed that bladder cancer risk increased as the dose and treatment duration of pioglitazone increased. As a result, the FDA added a warning about increased cancer risk on the drug’s label, which advised clinicians not to prescribe pioglitazone to patients already with an increased risk for cancer.  

Since then, a number of studies have disputed that claim, including on 2015 review that looked at 10 years of data and could not find any link between drug use and bladder cancer risk. However, a study published earlier this year in BMJ reported a 63% higher risk for bladder cancer among patients who were treated with pioglitazone.

After reviewing all of this data and other relevant studies, the FDA concluded in a news release that it still felt that there was a significant link between increased risk for cancer and pioglitazone use. 

A new label was therefore added to the drug that includes new this sentiment as well as information about these additional studies.—Sean McGuire