FDA announces changes to Actos® diabetes medication labeling

The U.S. Food and Drug Administration issued a notice to the public that they have approved updating drug labels of medications including pioglitazone, including Actos®. The added information states that, in patients using pioglitazone for more than one year, there can be an increased risk of bladder cancer.

The new wording for the label can be found in the Warnings and Precautions section of medicines containing pioglitazone. The patient Medication Guide will also be revised to indicate the bladder cancer association.

The FDA made this action after review a five-year interim analysis of a ten-year epidemiological study which found an increased risk of bladder cancer in patients who had taken Actos® the longest and those who had taken it at higher dosages.

It is interesting to note that the FDA did not suspend the sale of Actos® in this country though France has suspended the use of pioglitazone and Germany has recommended that physicians do not prescribe any new patients with the medication.

The FDA recommends:

  • Patients with bladder cancer should not take Actos®
  • Patients with a history of bladder cancer previously should decide whether the benefits of the drug outweigh the risk.

This information is provided by Washington Injury Attorney blog, a service of The Farber Law Group. We represent people who have been injured due to faulty medical devices and dangerous drugs, including Actos.

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