Actos Bladder Cancer Lawsuits Cross the Border to Canada

As attorneys in the United States gear up for court battles with Takeda Pharmaceuticals – the maker of the much-maligned diabetes drug Actos – their Canadian counterparts are facing their own legal battles against the pharmaceutical giant.

A class-action lawsuit was filed in the Ontario Superior Court of Justice after a Toronto woman died following a two-year battle with bladder cancer. The woman was prescribed Actos (pioglitazone) in 2002, the woman’s daughter said. She died in April 2011.

“My mother suffered greatly and was often in excruciating pain from the time of her cancer diagnosis to her death. Given the other widely available alternatives to control type-2 diabetes, my mother never would have taken Actos had she known that it would increase her risks of developing bladder cancer,” the woman’s daughter said.

A History of problems for Actos and Takeda Pharmaceuticals

This latest complaint against Takeda, Japan’s largest drug maker, underscores the far-reaching implications of the problems with the type-2 diabetes drug. Actos was approved for sale in the U.S. in 1999 and Canada in 2000. It was marketed as a safer alternative to Avandia (rosiglitazone), which was found to increase the risk of heart attacks.  Both Actos and Avandia come from the same drug family, thiazolidinedione (TDZ), and work in a similar manner.

In mid-2011, a study by the French National Health Insurance found a statistically significant increase in patients taking pioglitazone, when compared to patients taking other diabetes medicines. French authorities banned the drug in June 2011. About the same time, German drug regulators recommended that pioglitazones should not be started on new patients.

New Warnings, New Lawsuits

Although the U.S. Food and Drug Administration did not issue an Actos recall, it released a safety communication and a black-box warning, stating that the “use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer.”

This came after information from the first five years of a 10-year study that showed that patients taking Actos for more than a year had a 40 percent higher risk of bladder cancer. The FDA is reviewing the Actos case and is expected to come out with further results in the coming months.

In the hundreds of court cases that have been filed in the U.S., as with the Canadian case, Actos bladder cancer patients and their families allege Takeda knew about the risks and did not do enough to protect patients.