Patients taking the diabetes drug Actos (pioglitazone) for more than a year may have an increased risk of bladder cancer, according to the FDA. The warning came few days after German and France banned the use of the drug, citing similar concerns.
In a study involving more than 193,000 diabetics, compared to never being exposed to pioglitazone, the pioglitazone therapy for longer than 12 months was associated with a 40 percent increase in risk for bladder cancer, the FDA said. The five-year data of an ongoing ten-year study show that patients with the longest exposure to and the highest cumulative dose of the drug were at greater risk.
The new cancer warning will be required to appear on the labeling. The FDA is advising doctors not to use Actos in patients with bladder cancer and said diabetes patients should tell their doctor if they are having symptoms of bladder cancer such as blood or red color in urine, an urgent need to urinate or pain while urinating and pain in back or lower abdomen.
Actos is now the second medication in a class of drugs called thiazolidinedione (TZD) to be associated with serious side effects within the past year. Last year, the use of Avandia (rosiglitazone) was severely restricted in several countries including the U.S. because of an increased risk of heart attacks.
Actos is used to control blood sugar and is sold alone or in combination with metformin and glimepiride. Actos, Takeda Pharmaceuticals’ best-selling drug approved in 1999, was prescribed to more than 2 million patients with sales of $3.4 billion in 2010.
Since information about the potential bladder cancer risk associated with Actos first surfaced last year, a number of former users diagnosed with bladder cancer are considering pursuing an Actos lawsuit against Takeda Pharmaceuticals for failing to fully research the side effects of the medication or adequately warn about the potential risk of bladder cancer.