Actos (pioglitazone) is a diabetes drug manufactured by the Japanese firm Takeda Pharmaceuticals. Actos is a blockbuster drug in the United States, with over two million prescriptions filled in 2010.

Recent research studies in the US and Europe have associated Actos with a possible increased risk of bladder cancer, an aggressive form of cancer. As a result, Actos has been subject to recalls in Europe. No recall has been issued in the US, although the Food and Drug Administration (FDA) communicated the potential bladder cancer risk to the public and required updated Actos drug label safety warnings.

A European clinical study by the French National Health Insurance plan found a statistically significant risk of bladder cancer among 1.5 million diabetic patients taking Actos, with the risk increasing for periods of treatment longer than one year. A study by the French Medicines Agency found a 22 percent higher risk of bladder cancer in approximately 155,000 patients taking Actos from 2006 to 2009, compared to 1.3 million patients not taking the drug. The French Agency for the Safety of Health Products ordered an Actos recall in June 2011 in response. The German Federal Institute for Drugs and Medical Devices followed shortly thereafter by advising physicians not to prescribe Actos to diabetic patients. Actos has not yet been recalled in other European countries.

The European Medicines Agency (EMA) issued an Actos alert in July 2011 based on its review of bladder cancer risk. The EMA concluded that the benefits of Actos outweigh the bladder cancer risk for a limited group of type 2 diabetics, and that the small risk for these patients could be reduced by patient selection and exclusion, with continued review of Actos safety and treatment efficacy.

The FDA has not issued a recall for Actos in the United States. In September 2010, the FDA ordered an Actos safety review and continues to evaluate the results of an ongoing ten-year study in the US of long-term risk of bladder cancer in approximately 193,000 diabetic patients. The five-year results so far have shown no overall increased risk of bladder cancer from Actos use. However, a significantly increased risk of bladder cancer has been associated with the highest Actos dosages and with taking Actos for longer periods of time. In response, the FDA required updated Actos drug label warnings and informed the public that taking Actos for more than one year may be associated with an increased risk of bladder cancer. The FDA will continue to update the public on the results of its review as new data becomes available.

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