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WASHINGTON -- The FDA said today that an increased , thus current warnings about the risk will stay on the drug's label.
The conclusion came despite a 10-year study commissioned by Actos manufacturer Takeda showing no increased bladder cancer risk, as well as an independent study conducted in Europe with similar findings.
Earlier this year, a British analysis found a hazard ratio of 1.63 for bladder cancer among patients taking pioglitazone compared with other anti-diabetic agents, although the absolute risk remained very small.
In reviewing these and other studies, the FDA said, "Some studies found an increased risk of bladder cancer with pioglitazone use and others did not.... Overall, we conclude that pioglitazone may be associated with an increased risk in urinary bladder cancer, and we have updated the drug labels to include information about these additional studies."
The FDA first added warnings about possible bladder cancer risk with pioglitazone in 2011.
Pioglitazone is available as a generic drug as well as branded Actos, and it is also included in several fixed-dose combination products, such as with metformin.