FDA Drug Safety Communication: Pioglitazone and risk of bladder cancer

The U.S. Food and Drug Administration (FDA) has warned that use of pioglitazone for more than one year may be associated with an increased risk of bladder cancer. This safety information is based on FDA’s review of data from a planned five-year interim analysis of an ongoing, ten-year epidemiological study.

FDA recommends that healthcare professionals should:

  • Not use pioglitazone in patients with active bladder cancer.
  • Use pioglitazone with caution in patients with a prior history of bladder cancer. The benefits of blood sugar control with pioglitazone should be weighed against the unknown risks for cancer recurrence.