Welcome to FDA Drug Safety Podcasts for health care professionals. This is Lesley Navin, Advanced Practice Nurse from the Division of Drug Information.

 

On December 12, 2016, FDA announced as a result of an updated review, that it has concluded that use of the type 2 diabetes medicine pioglitazone (brand names 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 and works by increasing the body’s sensitivity to insulin. 

 

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.

 

We reviewed additional published studies evaluating the risk of bladder cancer in patients treated with pioglitazone. Results varied among the reviewed studies. For instance, the 10-year epidemiologic study did not find an increased risk of bladder cancer with pioglitazone use, whereas another study did. In addition, a randomized controlled trial found an increased risk during the trial period; however, the risk did not persist when patients were followed after the trial was completed. Furthermore, findings of these and other reviewed studies were conflicted about whether the duration of use and/or total dose over time of pioglitazone influenced the risk of bladder cancer. Overall, the data suggest that pioglitazone use may be linked to an increased risk of bladder cancer and drug labels have been updated to include information about these additional studies.

 

Side effects involving pioglitazone and other medications can be reported to FDA’s MedWatch program at www.fda.gov/medwatch.

 

A link to the full communication detailing specific information for health care professionals and the complete Data Summary can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at [email protected].