FDA to review Actos for bladder cancer risk

SILVER SPRING, Md. The Food and Drug Administration said Friday it had begun a safety review of Takeda’s Type 2 diabetes treatment Actos (pioglitazone) after receiving five-year data from a 10-year study Takeda Pharmaceuticals North America is conducting on the drug showing that some patients taking it could be at risk for bladder cancer.


The results showed no overall association between taking Actos and risk of bladder cancer, but there was an increased risk among those taking the drug for the longest period of time and in those taking it at the highest cumulative dose. The FDA said it had not concluded that the drug increases patients’ bladder cancer risk.



Actos belongs to the same class as GlaxoSmithKline’s Avandia (rosiglitazone), which has come under fire lately after being linked to heart problems in patients, though the drug remains available in the United States.


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