Actos Study Confirms Bladder Cancer Risk

A new Canadian study shows that taking the diabetes drug Actos for two years could double a patient’s risk for bladder cancer. According to the LA Times, Dr. Laurent Azoulay, an epidemiologist at Jewish General Hospital in Montreal, and his colleagues examined data from over 115,000 patients newly treated with diabetes drugs. They reported in the medical journal BMJ that patients who had ever taken pioglitazone (Actos) were 83% likelier to develop bladder cancer, and those using it for two years experienced a twofold increase in risk. In the United States, there are over 70,000 new cases of bladder cancer each year and over 14,000 deaths.

In June 2011, the FDA warned that taking Actos for more than a year increased the risk of bladder cancer .

It is noted that a possible explanatory mechanism for the bladder cancer risk is chronic irritation of the bladder from crystal formation, but more research is needed to make this conclusion. In an editorial accompanying the study, Dr. Dominique Hillaire-Buys and Dr. Jean-Luc Faillie in France wrote that "prescribers who are ultimately responsible for therapeutic choices can legitimately question whether the benefit-risk ratio of pioglitazone is still acceptable for their patients." Actos is manufactured by Eli Lilly and Company and Takeda Pharmaceuticals.

In June 2011, the FDA warned that taking Actos for more than a year increased the risk of bladder cancer and ordered the drug's manufacturer, Takeda Pharmaceutical North America, to update the drug’s labeling to include this warning. Hundreds of lawsuits have been filed against Eli Lilly and Takeda for allegedly purposely withholding study results and information that may have led it to be rejected by the U.S. Food and Drug Administration. All lawsuits filed in federal court against Actos for possible links to bladder cancer have been consolidated into the Western District of Louisiana.