Use of the diabetes drug pioglitazone (Actos) for more than 1 year may increase the risk of developing bladder cancer, according to a June 15 safety announcement from the FDA.
The announcement is based on a 5-year interim analysis of a 10-year prospective cohort study of safety data being conducted by the drug’s manufacturer, Takeda Pharmaceuticals. The study includes more than 193,000 patients who are part of the Kaiser Permanente Northern California health plan. All patients in the study are 40 years of age or older and have been diagnosed with diabetes.
No overall increase in bladder cancer risk was seen in those using pioglitazone compared with those who had never taken the drug. Patients who had been taking the drug for 12 to 24 months, however, had a 40 percent higher risk of developing bladder cancer than people who had never taken it.
“Although there was no overall increased risk of bladder cancer with pioglitazone use, an increased risk of bladder cancer was noted among patients with the longest exposure to pioglitazone, and in those exposed to the highest cumulative dose of pioglitazone,” the FDA reported.
French health officials recently announced similar findings from a much larger retrospective study of 1.2 million patients taking pioglitazone. Based on the finding, health officials in France halted the use of pioglitazone. In addition, German health officials have ordered clinicians not to prescribe the drug to new patients.
The FDA has advised U.S. physicians not to prescribe pioglitazone for patients with bladder cancer and to use it “with caution” in those who have been treated previously for bladder cancer. “The benefits of blood sugar control with pioglitazone should be weighed against the unknown risks for cancer recurrence,” the agency stated.
NCI Cancer Bulletin for June 28, 2011 - National Cancer Institute
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