An estimated 25.8 million children and adults in the United States—8.3% of the population—have diabetes.
The U.S. Food and Drug Administration (FDA) warned patients that use of the diabetes drug Actos (pioglitazone) may be linked to an increased risk of bladder cancer if taken for a year or more. Information about this risk was added to the Warnings and Precautions section of the Actos label in June.
Takeda Pharmaceutical Co., the manufacturer of Actos, faces up to as many as 10,000 Actos bladder cancer lawsuits, according to Bloomberg News.
Pioglitazone is the second drug in the thiazolidinedione (TZD) class of drugs to be associated with serious side effects in the past year. Avandia, another popular diabetes drug was linked to serious heart problems. Actos and Avandia have both dominated the market since the 1990s.
According to the agency, five-year data shows that while there is not an overall increase of bladder cancer, patients with the longest exposure to and the highest cumulative dose of the drug was at greater risk.
The European Medicines Agency (EMA) recently banned the use of Actos in European countries. But not all clinicians agree. Dr. Joel Zonszein of Albert Einstein College of Medicine in New York City called the European decision "precipitous and premature" because it was based on a retrospective study and found only a minor increase in cancer risk.
Patients with active bladder cancer should not take Actos.
Use Actos with caution in patients that have a history of bladder cancer. The benefits of using this drug should be weighed against the risk of bladder cancer with extended use.
If you are taking this drug and have any of the following symptoms, tell your doctor immediately – blood or red color in urine; urgent need to urinate or pain when doing so; pain in back or lower abdomen.
Talk to your doctor about your options before making the decision to stop taking this drug.
The agency is continuing to evaluate data from the ongoing ten-year study. The FDA will also conduct a comprehensive review of study results.