The FDA is informing the public that use of Actos (pioglitazone; Takeda) for more than one year may be associated with an increased risk of bladder cancer. Information about this risk will be added to the Warnings and Precautions section of the label for pioglitazone-containing medicines. This safety information is based on the FDA’s review of data from a planned five-year interim analysis of an ongoing, 10-year epidemiological study.

The five-year results showed that although there was no overall increased risk of bladder cancer with pioglitazone use, an increased risk of bladder cancer was noted among patients with the longest exposure to pioglitazone, and in those exposed to the highest cumulative dose of pioglitazone. Compared to never being exposed to pioglitazone, a duration of pioglitazone therapy >12 months was associated with a 40% increase in risk (HR 1.4; 95% CI 0.9–2.1). The hazard ratio after > 24 months of pioglitazone use was 1.4 (95% CI 1.03–2.0) and was of nominal statistical significance. Based on these data, the FDA calculated that duration of therapy >12 months was associated with 27.5 excess cases of bladder cancer per 100,000 person-years follow-up, compared to no previous use of pioglitazone. The FDA will continue to evaluate data from the ongoing 10-year study and will update the public when more information becomes available.

The FDA recommends that clinicians not use pioglitazone in patients with active bladder cancer and to use pioglitazone with caution in patients with a prior history of bladder cancer. Pioglitazone-containing drugs include: ACTOplusmet (pioglitazone/metformin; Takeda) and Duetact (pioglitazone/glimepiride; Takeda)

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