Still More Actos Bladder Cancer Lawsuits Are Filed

San Francisco, CAEven though it has been more than a year since the US Food and Drug Administration (FDA) issued a warning about the risk of Actos side effects including a potential link between Actos and bladder cancer, Actos lawsuits are still being filed alleging patients were harmed by their use of the medication.

A recently-filed Actos bladder cancer lawsuit, filed by the widow of a man who died of bladder cancer, alleges Actos is to blame for her husband's bladder cancer. According to Injury Lawyer News (10/31/12), the plaintiff's husband began Actos treatment in 2007. He was reportedly diagnosed with bladder cancer in 2010 and died in November 2010. The plaintiff alleges if Takeda Pharmaceuticals, maker of Actos, had included adequate warnings about the risk of bladder cancer associated with Actos, her husband would not have taken it.

On June 15, 2011, the FDA issued a warning about the link between Actos and bladder cancer. At the time, the FDA warned that use of Actos (known generically as pioglitazone) for longer than one year could be linked to an increased risk of bladder cancer. The announcement was made following an interim review of a Takeda study, which showed that patients who used Actos the longest and at the highest doses faced an increased risk of bladder cancer.

The study did not show an overall increased risk of bladder cancer.

"However, the risk of bladder cancer increased with increasing dose and duration of pioglitazone use," the FDA noted. "Compared to never being exposed to pioglitazone, a duration of pioglitazone therapy longer than 12 months was associated with a 40% increase in risk… Based on these data, FDA calculated that duration of therapy longer than 12 months was associated with 27.5 excess cases of bladder cancer per 100,000 person-years follow-up, compared to never use of pioglitazone."

A study conducted in France, however, did suggest an increased risk of bladder cancer, leading France to suspend the use of pioglitazone. The study from France found a statistically significant increased risk of bladder cancer in patients who used Actos when compared with those who were given other diabetes medications.

Actos is used to treat type 2 diabetes. It became a top-selling drug after rival drug Avandia had its uses severely restricted due to concerns about potential heart problems.