FDA safety communication on pioglitazone-containing drugs

As a result of an updated review, the US Food and Drug Administration has concluded that use of the type 2 diabetes medicine pioglitazone may be linked to an increased risk of bladder cancer.

These drugs include Japanese drug major Takeda Pharmaceutical’s (TYO: 4502) Actos, Actoplus Met, Actoplus Met XR, Duetact and Oseni brands. 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.

The FDA 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. The agency 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.