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In 2011, the FDA issued a safety warning for the antidiabetic drug pioglitazone (Actos). The warning states that use for longer than 1 year might be associated with excess risk for bladder cancer, based on data from a French study and an interim analysis of a manufacturer-sponsored, U.S. observational study. U.K. investigators now report on a case-control study in which they evaluated the same outcome.
Researchers identified 116,000 patients (mean age, 64) with type 2 diabetes who were new users of oral antidiabetic drugs. After a mean follow-up of 4.6 years, 470 patients had received diagnoses of bladder cancer (89 cases per 100,000 person-years). Each patient with bladder cancer was matched with as many as 20 controls. Ever use of pioglita…