FDA Approves Generic Actos Despite Mounting Lawsuits Over Bladder Cancer

By Sarah Mirando | August 24, 2012

Category: Pharmaceuticals

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By Sarah Pierce

Despite mounting lawsuits against Takeda Pharmaceuticals over its brand name diabetes drug Actos, the FDA approved a generic version of the medication, pioglitazone, last week. Actos is a popular medication used to treat type 2 diabetes, but has been linked to numerous cases of bladder cancer and other side effects, including heart problems. Hundreds of lawsuits have been filed against Takeda for failing to warn the public of these risks, and the drug was taken off the market in France and Germany. Actos attorneys say they are troubled by the FDA’s decision to approve a generic form of Actos given its well-documented dangerous side effects. They predict as many as 10,000 Actos lawsuits may be filed once patients learn the link between Actos and their injuries.

Hundreds of Actos lawsuits and mounting concern over the link between Actos and bladder cancer didn’t stop the FDA from approving the first generic version of the drug, manufactured by Mylan Pharmaceuticals, on August 17, 2012. Both the brand and generic drug will carry the same warnings that Actos (pioglitazone) may worsen heart failure, and that using it for more than one year may increase the risk of bladder cancer.

Several studies have been published in the past two years linking long-term Actos use to bladder cancer. On August 9, 2012 — just one week before the FDA approved the generic form of Actos — the Journal of the National Cancer Institute published a study concluding that Actos users are two to three times more likely to develop bladder cancer compared to patients taking other classes of diabetes medication.

The study supports findings in another Actos bladder cancer study published May 2012 in the British Medical Journal, which found that taking Actos for more than two years may increase the risk of bladder cancer by as much as 83 percent. Even the FDA has warned consumers that taking the drug for more than 12 months may increase their risk of bladder cancer by 40 percent.

So why did the FDA approve a generic form of such a dangerous medication?

No one knows for sure, but what is for certain is that Takeda will continue to face mounting litigation over Actos side effects. The first federal Actos bladder cancer lawsuits are set to go to trial on November 3, 2014, with a second trial set for July 8, 2015. They will serve as bellwether cases for the federal multidistrict litigation known as In re: Actos (pioglitazone) Products Liability Litigation (MDL No. 2299), where the majority of Actos lawsuits have been consolidated. These bellwether trials will be closely watched by both sides as they will determine the outcome of the remaining Actos lawsuits in the MDL. Plaintiffs and their attorneys are hoping Takeda will settle either before trial or that the trial jury will award damages, because that means Takeda will likely reach Actos lawsuit settlements in the remaining cases.

Victims of Actos bladder cancer are encouraged to speak with an Actos injury lawyer right away to see if they can join the Actos lawsuit MDL or have a case to file an Actos class action lawsuit. If your loved one died from Actos bladder cancer, you may be able to seek compensation through a wrongful death lawsuit. An experienced Actos compensation specialist can help you determine the best course of action for you and your family.

For more information, visit the Actos Bladder Cancer Class Action Lawsuit Investigation. Submit your information for a free consultation about your case. Actos attorneys are standing by to review your claims, and will fight to get the compensation you deserve.

Updated August 24th, 2012

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