FDA warns that pioglitazone may increase the risk of bladder cancer recurrence

FDA warns that pioglitazone may increase the risk of bladder cancer recurrence

The US Food and Drug Administration reports that use of the diabetes medication pioglitazone for more than one year may be associated with an increased risk of bladder cancer. Pioglitazone (known as Actos in the UK and US) is a thiazolidinedione or glitazone that is used in type 2 diabetes to reduce insulin resistance.

Review of data from a five-year interim analysis of an ongoing, ten-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.

The FDA recommends that healthcare professionals should not use pioglitazone in patients with active bladder cancer and with caution in patients with a prior history of bladder cancer.

Appraisal hints

Users of this evidence should consider

  • The balance of benefits of blood sugar control with pioglitazone against the unknown risks for cancer recurrence.


Food and Drug Administration. Actos (pioglitazone): Ongoing Safety Review – Potential Increased Risk of Bladder Cancer. 4th August 2011.

Douglas Badenoch
I am an information scientist with an interest in making knowledge from systematic research more accessible to people who need it. This means you. I've been attempting this in the area of Evidence-Based Health Care since 1995. So far the results have been mixed. For some reason we expected busy clinicians to search databases and appraise papers instead of seeing patients. We also expected publishers to make the research freely available to the people who paid for it.. Ha! Hence The National Elf service.

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