Information about Actos and bladder cancer.

FDA delays review for drug with Actos ingredient

January 4th, 2011

The Food and Drug Administration has delayed plans to review a new diabetes medication that contains the primary ingredient found in Actos. Takeda Pharmaceuticals submitted the new drug for review in July after it was originally rejected by the FDA for insufficient data.

The proposed drug is a fixed-dose combination of alogliptin and pioglitazone—the primary ingredient of Actos. The diabetes drug has recently been linked to an increased risk of developing bladder cancer. The FDA recently updated the warning on Actos to include the risk of bladder cancer.

Independent studies linking Actos to bladder cancer caused European health officials to pull the drug from the market. One study found patients who took Actos for at least one year were 40% more likely to develop bladder cancer, while another found patients were more likely to develop bladder cancer regardless of how long he or she took the drug.

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