September 17th, 2010

FDA Announces Safety Review of Pioglitazone

The FDA announced today that it was undertaking a safety review of pioglitazone (Actos). The review was initiated after the FDA received data from Takeda, the drug’s manufacturer, suggesting a possible increase in bladder cancer in patients taking the drug for more than 2 years. The data are taken from a planned 5-year analysis of an ongoing 10-year epidemiological study designed to examine the association of the drug with bladder cancer, following earlier studies suggesting a possible risk. Although the current analysis found no overall association between pioglitazone and bladder cancer, a further analysis found an increased risk of bladder cancer in those taking the highest cumulative doses of the drug and in those with the longer exposure to the drug.

The FDA said it has not yet concluded that piolglitazone increases the risk of bladder cancer and advised healthcare professionals to continue to follow the recommendation in the drug label.

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