FDA Adds Bladder Cancer Warnings to Takeda's Actos

Source: FDA.gov

Dec 14, 2016

The U.S. FDA has concluded that use of Takeda's Actos (pioglitazone), a type 2 diabetes medicine, may be linked to an increased risk of bladder cancer and has approved label updates.

Pioglitazone is sold as a generic in addition to Actos and several other drugs, as well as in fixed-dose combination drugs, often containing metformin.

The agency first added a warning about the increased risk for bladder cancer to the pioglitazone's label in 2011. After analyzing new studies, the agency has again concluded that pioglitazone may be linked to an increased risk for bladder cancer and will update the drug's label to describe the additional studies that were reviewed.

Read the FDA announcement