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Actos Lawsuit Tidal Wave Expected After Bladder Cancer Warnings

Aug 29, 2011 | Parker Waichman LLP

Plaintiffs' lawyers across the country are poised to file hundreds of Actos bladder cancer lawsuits, according to a report from the Associated Press. Over the past year, evidence linking Actos to bladder cancer has grown, and this summer, regulators in both Europe and the U.S. mandated stronger warnings for the drugs regarding its possible association with bladder cancer.

Actos, a once- day pill that increases the body's sensitivity to insulin, was approved by U.S. Food & Drug Administration (FDA) to treat Type 2 Diabetes in July, 1999. It became the best-selling diabetes drug in the world after studies linked rival Avandia to an increased risk of heart attacks and death. Last year, Actos generated $4.3 billion in sales for Takeda Pharmaceuticals.

In June, the FDA mandated that new information regarding bladder cancer be added to the "Warnings and Precautions" section of the Actos label, after interim data from an on-going 10 year study found that users may face an increased risk the longer they take the drug. Data from the Takeda-conducted study indicated after 24 months, the rate of exposure and the increased risk of bladder cancer reached statistical significance.

Just days later, France, and then Germany, suspended sales of Actos in those countries, after a separate study commissioned by the French government found an increased people taking Actos at doses greater than 28,000 milligrams for longer than one year faced an increased risk of bladder cancer.

According to a recent Associated Press report, plaintiffs lawyers have reported receiving up to 40 new inquiries per week from potential Actos bladder cancer claimants. The first lawsuits were filed over the summer, after the FDA issued its warning, and attorneys believed hundreds will be filed eventually.

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