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Bladder Cancer Risk May Increase with Long-Term Actos Use, FDA Says

Jun 16, 2011 | Parker Waichman LLP

Taking the diabetes drug Actos (pioglitazone) for more than a year could put users at risk for bladder cancer, according to a new Drug Safety Communication issued by the U.S. Food & Drug Administration (FDA).  The FDA is advising doctors not to prescribe Actos to people with active bladder cancer, and to use it with caution in those who have a history of the disease.

The FDA's Actos bladder cancer warning comes a week after regulators in France and Germany suspended sales of the drug, following findings from a French study that found people taking Actos faced a higher risk of bladder cancer.  According to the FDA, it is evaluating the findings from that study.

The FDA's new Drug Safety Communication was prompted by its analysis of five-year data from a decade-long study that indicated people with the longest exposure to and the highest cumulative dose of Actos were at greater risk of bladder cancer.  However, the data did not indicate an overall increased risk.

The FDA will continue to evaluate data from the ongoing ten-year epidemiological study, and will also conduct a comprehensive review of the results from the French study. The FDA said it will update the public when more information becomes available. For now, information regarding bladder cancer is being added to the "Warnings and Precautions" section of the Actos label, and to the labels of drugs containing pioglitazone including Actoplus Met, Actoplus Met XR and Duetact.

Bladder cancer is estimated to occur in 20 per 100,000 persons per year in the US, according to the FDA. The rate of occurrence is thought to be higher in diabetics.

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