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Actos Bladder Cancer Lawsuit Expected to be First of Hundreds

Aug 8, 2011 | Parker Waichman LLP

Actos maker Takeda Pharmaceuticals can expect to be named in hundreds of bladder cancer lawsuits.  Several plaintiffs lawyers recently told the Associated Press that their firms are preparing to file more than a hundred cases each, and they continue hear from more alleged Actos bladder cancer victims every day.

What is believed to be the first Actos bladder cancer lawsuit in the U.S. was filed by a 54-year-old Pennsylvania woman who took the type 2 diabetes drug  for a decade and developed recurrent bladder cancer.  According to the Associated Press, the plaintiff was diagnosed with bladder cancer in 2009. In June, she had her second surgery to remove tumors, and is awaiting word as to whether she will need further treatment.

The lawsuit comes about two months after a French study found that Actos patients who had been taking it the longest and at the highest cumulative doses face about a 22 percent higher risk of developing bladder cancer compared to patients taking other diabetes drugs.  The French and German governments suspended sales of Actos, and Takeda has since announced that it would withdraw the drug in both countries.  Both the U.S. Food & Drug Administration (FDA) and regulators in the European Union have beefed up Actos label warnings in response to the study.

All of this is expected to hit Actos sales extremely hard.  For now it's the best selling diabetes drug in the world, but according to the Associated Press, doctors and patients are already looking at other options.

"The consensus already is that (Actos) should only be considered ... after patients have exhausted all other options," Dr. Harlan Krumholz, a Yale School of Medicine professor who directs its Center for Outcomes Research and Evaluation, told the Associated Press.



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