In September 2010, the Food and Drug Administration ordered a safety review of Actos based on preliminary data indicating a possible risk of bladder cancer. The FDA is reviewing data from an ongoing ten-year study to evaluate bladder cancer risk, after findings in animal and human studies suggested a need for further evaluation. The ten-year study is observing the long-term risk of bladder cancer associated with Actos in approximately 193,000 diabetic patients. The five-year results so far have shown no overall increased risk of bladder cancer from Actos use.
However, a significantly increased risk of bladder cancer has been associated with patients taking the highest Actos dosages and with patients taking Actos over the longest periods of time. Based on its safety review, the FDA has required updated Actos drug label warnings and is informing the public that taking Actos for more than one year may be associated with an increased risk of bladder cancer.
The FDA will continue to update the public on the results of its review and as new data becomes available.
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