Actos and bladder cancer risk

The diabetes drug pioglitazone (Actos) is the subject of a new warning from the FDA regarding possible bladder cancer risk associated with use of the drug. The FDA ongoing safety review suggests that use of pioglitazone for more than 1 year may be associated with increased risk of bladder cancer based on review of a 5-year interim analysis of an ongoing 10-year epidemiologic study. Patients who had been on pioglitazone the longest and who had the highest cumulative dose of the drug had a slightly increased risk of bladder cancer. This warning falls on the heels of a French study that also showed increased risk of bladder cancer. Based on these findings, France's drug regulatory agency has suspended use of the drug. While the FDA is not recommending withdrawing the drug from the market, it does recommend avoiding pioglitazone in patients with active bladder cancer and using it with caution in patients with prior history of bladder cancer. Thiazolidinediones — including pioglitazone — have also come under scrutiny in recent years because of increased risk of congestive heart failure and bone fractures in females.