FDA Reviewing Safety Data On Actos, Bladder Cancer Risk

The Food and Drug Administration Sept. 17 announced that it has begun a safety review of the diabetes drug Actos (pioglitazone), after receiving preliminary results from a long-term observational study designed to evaluate the risk of bladder cancer associated with the use of this drug.

The preliminary results showed no overall association between Actos exposure and the risk of bladder cancer, FDA said. However, there was an increased risk of bladder cancer in patients with the longest exposure to Actos and in those with the highest cumulative dose of the drug.

FDA said the early results are based on five-year ...