Lawsuit Alleges Bladder Cancer from Actos After Only Four Months Use

A Louisiana man has filed a lawsuit alleging that the side effects of Actos, Takeda Pharmaceutical’s popular diabetes drug, caused him to develop bladder cancer after using the medication for just a few short months. 

The complaint (PDF) was filed last month by Darin Andrews, in U.S. District Court for the Middle District of Louisiana, where all federal lawsuits over bladder cancer from Actos have been consolidated as part of an MDL, or multidistrict litigation.

Although most lawsuits filed against Takeda Pharmaceuticals involve individuals who developed bladder cancer after using Actos for long periods of time, Andrews indicates that he was diagnosed in October 2011, after using the diabetes drug from April through July 2011.

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Actos (pioglitazone) was developed by Takeda Pharmaceuticals and approved in the United States for treatment of type 2 diabetes in July 1999.  It is a once-daily pill that increases the body’s sensitivity to insulin.  Related medications that also contain the same active pharmaceutical ingredient include ActoPlus Met and Duetact.

Over the past 18 months, concerns have emerged about the risk of bladder cancer from Actos, after interim data released in September 2010 indicated that long-term use of the diabetes drug was linked to an increased rate of bladder cancer.

In June 2011, the FDA issued a drug safety communication to indicate that new information would be added to the warning label for Actos, which indicates that use of the medication for more than one year may increase the risk of developing bladder cancer. Although regulators in France removed the diabetes drug from the market due to the risk, the FDA has not indicated that a recall for Actos will be issued in the United States.

Andrews alleges that Takeda Pharmaceuticals concealed their knowledge that Actos can cause bladder cancer, and indicates that the medication was the direct and proximate cause of his diagnosis.

“[Takeda Pharmaceuticals] actually knew of the defective nature of their product… yet continued to design, manufacture, market, distribute and sell [Actos] so as to maximize sales and profits at the expense of the general public’s health and safety in conscious disregard of the foreseeable harm caused by this product,” Andrews alleges in the complaint.

Andrews’ lawsuit joins a growing number of cases brought against the drug maker in federal and state courts throughout the United States. The federal Actos litigation has been consolidated for pretrial proceedings before Judge Rebecca F. Doherty, in the U.S. District Court for the Western District of Louisiana.

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