Heavy Actos Use May Be Tied to Bladder Cancer

Patients taking Takeda Pharmaceuticals’ Actos at higher cumulative doses for longer periods of time may be at a higher risk of bladder cancer, according to the FDA. Although interim study reports suggested no overall link with cancer, an association was found amongst the heaviest users.

The FDA said that the drug should not be used by patients with active bladder cancer. Patients with a family history of bladder cancer should be particularly cautious when taking the drug, the agency said. The FDA first announced a safety review of Actos in September prompted by preliminary five-year data from a 10-year study of the drug.

The 10-year study involves 193,099 patients with diabetes who are members of the Kaiser Permanente Northern California Health Plan. Takeda Pharmaceuticals is funding the study, intended to address concerns about the drug’s impact on bladder health. Another study on Actos conducted in France shows an increased risk of bladder cancer, prompting French health authorities to suspend the drug.

Actos is in the same group of drugs as GlaxoSmithKline’s PLC Avandia. The FDA restricted use of Avandia last year after determining that the drug might increase the risk of heart attacks and strokes.

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