Actos is the brand name of the prescription drug pioglitazone, which is taken to treat Type 2 diabetes. At least 3,000 lawsuits have been filed in the US by consumers who developed bladder cancer after taking Actos, which is manufactured by Takeda Pharmaceuticals, based in Japan.
FDA Issues Warning
The U.S. Food and Drug Administration (FDA) first approved the drug in 1999. In July 2011, the FDA issued a warning that the use of Actos for more than one year “may be associated with an increased risk of bladder cancer.” This warning came from analyzing the five-year interim results of an ongoing 10-year study. The cancer link was also supported by a study completed in France.
The FDA didn’t issue a recall of the drug, but released a set of warnings. The warnings focused on use of the drug in patients with bladder cancer or a prior history of bladder cancer. The FDA noted that doctors should weigh the benefits of the drug, which offers control of blood sugar, against the risks for cancer. At least three countries have now banned the drug – France, Germany, and India.
In legal action, plaintiffs’ attorneys have argued that prior to the 1999 roll out in the U.S., the manufacturer possessed study results from lab animals showing an increased risk of bladder cancer for animals who took the drug. Allegedly, the manufacturer did not report these findings to the FDA.
In 2013, a California state-level jury found that the manufacturer failed to adequately disclose the risks of bladder cancer. The jury awarded the plaintiff $6.5 million, but the judge set aside the verdict, and the case is now under appeal.
The first federal trial began this week as many lawsuits have been consolidated. One of the leading law firms said of the federal case, “We intend to show that Takeda Pharmaceuticals knew about the risks associated with Actos, yet it failed to inform patients of the increased risk of bladder cancer when taking Actos.”
Consumers who used Actos and developed bladder cancer may be eligible for compensation for medical expenses, lost wages, pain and suffering, and other damages.
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