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Updated FDA Review Suggests Link Between Actos and Bladder Cancer

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Santa Clara, CAFindings from an updated review by the US Food and Drug Administration (FDA) on the use of type 2 diabetes medicine pioglitazone (Actos, Actoplus Met, Actoplus Met XR, Duetact, Oseni) suggests there may be an increased risk for bladder cancer associated with drug.

The FDA has issued an alert based on their findings. Additionally, the agency has approved changes to describe their findings on labeling for pioglitazone-containing medicines, which already contain warnings about the possible risk for bladder cancer.

In September 2010 and June 2011 the agency issued public alerts about the possible risk of bladder cancer based on interim results from a 10-year epidemiologic study.” We changed the labels of pioglitazone-containing medicines in August 2011 to include warnings about this risk, and required the manufacturer to modify and continue the 10-year study,” the FDA notes in its latest statement.

The latest FDA communication states that “health care professionals should not use pioglitazone in patients with active bladder cancer, and should carefully consider the benefits and risks before using pioglitazone in patients with a history of bladder cancer.”

Pioglitazone is approved to improve blood sugar control, along with diet and exercise, in adults with type 2 diabetes. Pioglitazone works by increasing the body’s sensitivity to insulin, a natural hormone that helps control blood sugar levels. Untreated, type 2 diabetes can lead to serious problems, including blindness, nerve and kidney damage, and heart disease.


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