Drug Safety and Availability > FDA Drug Safety Communication: Update to ongoing safety review of Actos (pioglitazone) and increased risk of bladder cancer: "his safety information is based on FDA's review of data from a planned five-year interim analysis of an ongoing, ten-year epidemiological study1, described in FDA's September 2010 ongoing safety review and in the Data Summary below. 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."
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