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Actos Warnings and Safety Alerts

FDA Safety Alert: Risk of Bladder Cancer 40 Percent Greater in Patients Taking Actos for Longer than One Year

The Food and Drug Administration (FDA) issued a safety announcement warning that prolonged use and increased dose of Actos (pioglitazone) has been linked to a 40 percent increased risk of bladder cancer.

Actos, manufactured by Japanese pharmaceutical company Takeda Pharmaceuticals, is a drug given to millions of patients worldwide to treat type II diabetes.

The FDA reviewed preliminary data from an ongoing 10-year observational study, funded by Takeda, which is designed to evaluate whether Actos (pioglitazone) is linked to an increased risk of bladder cancer by observing diabetic patients from the Kaiser Permanente Northern California (KPNC) health plan. During its review of the data, the FDA found that patients taking pioglitazone for longer than one year were 40 percent more likely to develop bladder cancer then patients who had not been exposed to the medication. The analysis of the data also found that higher doses of pioglitazone could increase the risk of bladder cancer.

The risk of bladder cancer increased with increasing dose and duration of pioglitazone use. Compared to never being exposed to pioglitazone, a duration of pioglitazone therapy longer than 12 months was associated with a 40% increase in risk,” the agency reported.

In its safety announcement, the FDA also cited findings from animal studies and clinical trials that “suggest this is a potential safety risk that needs further study.” In lieu of the recent statistical associations between pioglitazone and bladder cancer, the FDA has recommended that physicians not prescribe the diabetes medication to anyone with active bladder cancer or a history of bladder cancer.

The FDA stopped short of recalling Actos even after France and Germany decided to suspend the use of drugs containing pioglitazone. Both countries decided to suspend the drug after a French study showed a statistically significant risk for bladder cancer among patients taking pioglitazone. The Warnings and Precautions section of Actos label, as well as the patient Medication Guide, will be revised to include the new information regarding bladder cancer risk.