Actos pioglitazone regulatory update

FDA is reviewing the safety of Actos pioglitazone from Takeda after interim data from a long-term trial showed a significantly increased risk of bladder cancer in patients exposed to the diabetes drug for more than 24 months. However, the agency said there was no significant overall association between any Actos exposure and bladder cancer risk. The ongoing, ten-year observational trial is evaluating new diagnosis of bladder cancer in 193,099 diabetic patients on the Kaiser Permanente Northern California health plan. ...