FDA: taking Actos may increase risk of bladder cancer

The FDA released an Actos safety warning in June following a study linking prolonged exposure to Actos and an increased risk of bladder cancer. Actos’ manufacturer responded to the announcement by submitting a revised warning label to the FDA, adding an increased risk of bladder cancer to the list of Actos side effects. The new warning label was recently approved by the FDA.

Actos Warning Label Updates

On August 4, the FDA approved major changes to the “Warning and Precautions” section of the Actos label to reflect the increased risk of bladder cancer. The approved label advises doctors to refrain from using the drug on patients with bladder cancer and cautions the use of the drug on patients with bladder cancer in their history.

Reportedly, the label will also be used on other products that contain Actos’ active ingredient, pioglitazone, including Actoplus Met (pioglitazone/metformin) and Duetact (pioglitazone/glimepiride). For these medications, changes have been made to the “Precautions” and “Medication Guide” sections of the labeling regarding bladder cancer.