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Actos (Pioglitazone)

The medication Actos (pioglitazone) is used to treat type 2 diabetes. It is in a class of medications called thiazolidinediones and works by increasing the body's sensitivity to insulin, a natural substance that helps control blood sugar levels. Patients taking Actos for more than a year may have an increased risk of bladder cancer, according to a U.S. Food and Drug Administration (FDA) interim review of an ongoing epidemiological study. The FDA is informing the public that use of the diabetes medication Actos for more than one year may be associated with an increased risk of bladder cancer. Information about this risk will be added to the Warnings and Precautions section of the label for pioglitazone-containing medicines. The patient Medication Guide for these medicines will also be revised to include information on the 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, 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. The FDA is also aware of a recent epidemiological study conducted in France which suggests an increased risk of bladder cancer with pioglitazone. Based on the results of this study, France has suspended the use of Actos and Germany has recommended not to start Actos in new patients.