FDA updates ongoing safety review of Actos

SILVER SPRING, Md. — The Food and Drug Administration on Thursday informed the public that continued use of a Type 2 diabetes treatment made by Takeda Pharmaceuticals for more than one year may be associated with an increased risk of bladder cancer.

As part of its ongoing safety review of Actos (pioglitazone), the FDA said that information about this risk will be added to the "warnings and precautions" section of the label for the drug and other pioglitazone-containing medicines. In response, Takeda said that it "is working with [the] FDA to make appropriate updates to the prescribing information."

The drug maker also confirmed that it is supporting a 10-year epidemiological study that investigates the questions raised about the association of Actos and bladder cancer. The study, which commenced in 2002, is being conducted by the University of Pennsylvania and Kaiser Permanente Diabetes Registry of Northern California. Takeda noted it will support the study through its conclusion at the end of 2012 and will report on the study results upon completion.

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