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FDA chasing Actos cancer signal

September 18, 2010 12:17 AM UTC

FDA is reviewing the safety of Actos pioglitazone from Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) 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, 10-year observational trial is evaluating new diagnosis of bladder cancer in 193,099 diabetic patients on the Kaiser Permanente Northern California health plan.

FDA said it has no clinical information associating the cancer signal with Avandia rosiglitazone, the only other drug in the thiazolidinedione (TZD) peroxisome proliferation activated receptor (PPAR) agonist class. The agency has said it will soon announce what steps it will take on Avandia after a July FDA advisory committee met to discuss cardiovascular risks associated with the diabetes drug. GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) markets Avandia. ...