The maker of Actos, Takeda Pharmaceuticals, Inc., began a 10 year study of Actos in 1997 to determine to what extent it increased bladder cancer risks. The FDA's interim review of the Actos safety study prompted the agency to issue an FDA warning for Actos bladder cancer in September of 2010. The FDA Actos Cancer Warning stated, "Findings from studies in animals and humans suggest this is a potential safety risk that needs further study." The FDA Actos Bladder Cancer Warning went on to mention that bladder cancer occurred most prevalently in those who had used Actos the longest as well those that took the highest doses. The FDA Actos Bladder Cancer Warning included the following statement, "the risk of bladder cancer increased with increasing doses and duration of Actos use."

Second FDA Actos Bladder Cancer Warning Issued June 15, 2011

Less than one year after its first Actos bladder cancer warning, the FDA issued an update changing the duration of Actos use required to increase the risk of bladder cancer from two years to just one, stating "use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer." The FDA also cited the actions take in France and Germany where Actos was removed from the market. Takeda Pharmaceuticals, Inc. conducted a voluntary recall of Actos in France, but only after the French Agency for the Safety of Health Products suspended sales of the drug. The German agency requested doctors not prescribe Actos to patients not already using the medication.

Actos Label Changed to Include Bladder Cancer Warning

When the FDA issued the update to its initial Actos Bladder Cancer Warning, the Actos label was also changed. The Actos packaging insert now includes bladder cancer information in the Warnings and Precautions section.

Was the FDA Actos Bladder Cancer Warning Issued Too Late?

Although Actos was approved by the FDA in 1999, it wasn't until the past two years that the FDA began advising doctors and patients about the increased risks of bladder cancer from using Actos. Because of the known cardiovascular risks associated with the similar diabetes drug Avandia (riglitazone), early studies on Actos (pioglitazone) focused on whether it might also cause cardiovascular disease such as heart attack and stroke, despite the fact that its earliest tests provided a warning that Actos could cause bladder cancer. In August of 2007 the FDA issued its first Actos warning that Actos "may cause or exacerbate heart failure."

Although Actos was shown to increase the risk of bladder cancer in some of the drug's first tests, those performed on laboratory animals, clinical testing on Actos focused on cardiovascular disease rather than bladder cancer. With millions of persons already using Actos, was the FDA slow to issue the Actos bladder cancer warning? With billions of dollars at stake, was Takeda Pharmaceuticals, Inc. slow to inform the public about Actos bladder cancer risks and care for the drug's users?