Actos, known generically as pioglitazone, came on the market in 1999 and is approved to treat type 2 diabetes. Other drugs that contain pioglitazone include ActoPlus Met, ActoPlus Met XR, and Duetact. According to Actos bladder cancer lawsuits, even before it was put on the market, animal studies had indicated pioglitazone could cause bladder tumors in rats. When the FDA approved Actos, it also mandated that Takeda Pharmaceuticals conduct a 10-year study into the bladder-cancer risk associated with pioglitazone.
In September 2010, the FDA announced it was launching a safety review of Actos after interim results of that study indicated long-term use of Actos could increase the risk of bladder cancer. In June 2011, the FDA issued a Drug Safety Communication warning that using Actos for one year increased bladder cancer risks by 40 percent. The FDA ordered that the Warnings and Precautions section of the Actos label be updated to warn of this risk.