FDA Updates Actos Warning Label Due to Cancer Risk


The FDA has recently updated the warning label for the popular diabetes drug Actos in order to warn consumers about an increased risk of bladder cancer associated with long term usage of the drug. The new warning recommends that patients with active cases of bladder cancer and those with a history of bladder cancer do not use the drug at all, while other diabetes patients should explore other options before taking Actos. These findings are based on preliminary analysis of an ongoing long term study of the drug, financed by Takeda Pharmaceuticals, the maker of Actos.

The data analyzed by the FDA indicated that Actos patients experienced a 40% greater risk of bladder cancer after taking the drug for at least one year.

Recently, Actos was pulled from the market in Germany and France. However, it is still available in the United States and the majority of countries in Europe. Actos is taken to control blood sugar levels in diabetes patients. It works by increasing the body’s sensitivity to insulin.

Actos is the second major diabetes drug to be associated with serious pharmaceutical injuries in recent years. In 2007, studies determined that Avandia was associated with an increased risk of heart attacks. Since then, Avandia has been banned in Europe, and sales across the United States have declined sharply.

This month, the first pharmaceutical injury lawsuits were filed against Actos. It is expected that Takeda Pharmaceuticals may potentially face thousands of similar lawsuits over the next few years.