The FDA is informing the public that using the diabetic medication pioglitazone (Actos) for more than 1 year may be associated with an increased risk of bladder cancer.
Information about this risk will be added to the "Warnings and Precautions" section of the label for pioglitazone-containing medicines. The patient medication guide for these medicines will also be revised to include information on the risk of bladder cancer.
According to the FDA, this safety information is based on the FDA’s review of data from a planned 5-year interim analysis of an ongoing, 10-year epidemiologic study. The 5-year results showed that although there was no overall increased risk of bladder cancer with pioglitazone use, an increased risk of bladder cancer was noted among patients with the longest exposure to pioglitazone and in those exposed to the highest cumulative dose of the drug.
The FDA recommends that health care professionals should not use pioglitazone in patients with active bladder cancer and use it with caution in patients with a history of bladder cancer. The benefits of blood sugar control with pioglitazone should be weighed against the unknown risks for cancer recurrence.
The FDA is also aware of a recent epidemiologic study conducted in France, which suggests an increased risk of bladder cancer with pioglitazone. Based on the results of this study, France has suspended the use of pioglitazone, and Germany has recommended not to start pioglitazone in new patients. The FDA said it will continue to evaluate data from the ongoing 10-year epidemiologic study and will also conduct a comprehensive review of the results from the French study.
In a statement, Takeda Pharmaceuticals North America, Inc., the maker of pioglitazone, said it "is confident in the therapeutic benefits of Actos and its importance as a treatment for type 2 diabetes. The company remains committed to Actos and Actos-containing medications, and to the millions of people living with the disease."