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Actos Bladder Cancer Lawsuits Piling Up

Aug 23, 2011 | Parker Waichman LLP

Another alleged victim of Actos bladder cancer has filed suit against Takeda Pharmaceuticals, claiming warnings for the type 2 diabetes medication were inadequate.  The lawsuit, filed in San Francisco, is just the latest of what is expected to be thousands of Actos bladder cancer claims.

Actos users who developed bladder cancer while taking the drug began filing lawsuits earlier this summer, after the U.S. Food & Drug Administration (FDA) released interim data from a review of 193,099 diabetics which showed that those taking the drug for more than a year had a 40 percent increased risk for bladder cancer.  The findings prompted the FDA to order that additional information regarding bladder cancer be added to the Actos label.

The same month the FDA acted, a second study commissioned by the French government that involved 1 million patients found that those taking Actos faced nearly a 22 percent higher risk of bladder cancer compared to those on other drugs. The bladder cancer risk was highest in those receiving a cumulative Actos dosage of 28,000 mg or more during the study period. 

The French study results caused an Actos recall in France and Germany.  The European Medicines Agency has also called for new bladder cancer warnings for Actos, including a six month review for every patient taking the drug.

The FDA is continuing its ongoing review of Actos and bladder cancer, and is taking a look at the French study.  For now, the agency advises that health care professionals avoid using Actos in patients with active bladder cancer and recommends caution in patients with a prior history of bladder cancer. Actos patients are encouraged to contact their health care provider if they notice any sign of blood in the urine, any new or worsening urinary urgency or pain during urination.

It is expected that victims of Actos bladder cancer will litigation will be massive.  Earlier this moth, several lawyers told the Associated Press that they have 100 or more Actos bladder cancer cases pending at their firms.

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