Actos and Bladder Cancer Risk

On June 15, 2011, the U.S. Food and Drug Administration (FDA) issued a warning that patients who take Actos for more than a year may have an increased risk of bladder cancer. U.S. officials issued the warning shortly after France banned the drug and Germany advised doctors not to start new patients on the drug.
The FDA advised doctors not to prescribe Actos and piolitazone-containing drugs to patients who have suffered from bladder cancer. The agency also cautioned patients to tell their doctors if they experience any symptoms of bladder cancer.

On August 4, 2011, the FDA approved new warnings on the label and patient medication guide for Actos and other medications containing pioglitazone (including Actoplus Met, Actoplus Met RX, and Duetact). The warning cautions patients that taking the drug for more than one year may be associated with an increased risk of bladder cancer.
The FDA’s warning follows the agency’s review of five years’ data from an ongoing epidemiological study undertaken by Acto’s manufacturer, Takeda Pharmaceuticals. Early testing showed an increased bladder cancer risk in laboratory animals; because of these troubling findings, the FDA asked Takeda to conduct a long-term study tracking bladder cancer in Actos patients. In 2010, the FDA conducted an interim review of data from the ongoing study and concluded that the risk of bladder cancer required further study.

The FDA next analyzed five years of data on 193,099 diabetic patients who had taken Actos for a median length of two years. This study found that patients taking Actos for over a year are at a 40% increased risk of developing bladder cancer compared to people who never took the medication. The risk of bladder cancer increases most for patients with the longest exposure and the highest cumulative (lifetime) dose of Actos. A French epidemiological study involving insurance data of 1.5 million patients taking the drug similarly revealed an increased risk of bladder cancer, particularly in men. The FDA continues to review data from the ongoing Takeda study and is also conducting a comprehensive review of the French study.