FDA Drug Safety Communication on pioglitazone- Drug Information Update

The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.

As a result of an updated review, the U.S. Food and Drug Administration (FDA) has concluded that use of the type 2 diabetes medicine pioglitazone (Actos, Actoplus Met, Actoplus Met XR, Duetact, Oseni) may be linked to an increased risk of bladder cancer. The labels of pioglitazone-containing medicines already contain warnings about this risk, and we have now approved label updates to describe the additional studies we reviewed.

We alerted the public about the possible risk of bladder cancer in September 2010 and June 2011 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.

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.

For more information, please visit: pioglitazone.