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  • FDA Date: 12/12/2016

    Pioglitazone 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

    This information reflects FDA's current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available.

    As a result of an updated review, the U.S. Food and Drug Administration (FDA) has concluded that use of the type 2 diabetes medicine pioglitazone (Actos, Actoplus Met, Actoplus Met XR, Duetact, Oseni) may be linked to an increased risk of bladder cancer. The labels of pioglitazone-containing medicines already contain warnings about this risk, and we have now approved label updates to describe the additional studies we reviewed.

    We alerted the public about the possible risk of bladder cancer in September 2010 and June 2011 based on interim results from a 10-year epidemiologic study. We changed the labels of pioglitazone-containing medicines in August 2011 to include warnings about this risk, and required the manufacturer to modify and continue the 10-year study.

    Pioglitazone is approved to improve blood sugar control, along with diet and exercise, in adults with type 2 diabetes. Pioglitazone works by increasing the body's sensitivity to insulin, a natural hormone that helps control blood sugar levels. Untreated, type 2 diabetes can lead to serious problems, including blindness, nerve and kidney damage, and heart disease.

    Health care professionals should not use pioglitazone in patients with active bladder cancer, and should carefully consider the benefits and risks before using pioglitazone in patients with a history of bladder cancer.

    We reviewed additional published studies evaluating the risk of bladder cancer in patients treated with pioglitazone. Results varied among the reviewed studies. For instance, the 10-year epidemiologic study did not find an increased risk of bladder cancer with pioglitazone use, whereas another study did. In addition, a randomized controlled trial found an increased risk during the trial period; however the risk did not persist when patients were followed after the trial was completed. Furthermore, findings of these and other reviewed studies conflicted about whether the duration of use and/or total dose over time of pioglitazone influenced the risk of bladder cancer. We also previously communicated in 2010 that bladder tumors were seen with pioglitazone exposure in animal studies. Overall, the data suggest that pioglitazone use may be linked to an increased risk of bladder cancer.

    View the full FDA Drug Safety Communication on FDA.gov