Takeda Troubled by Actos Lawsuits

By Sarah Mirando | April 11, 2013

Category: Pharmaceuticals

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By Anne Bucher

Actos (pioglitazone) is a class of medications known as thiazolidinediones. Actos was approved by the U.S. Food & Drug Administration (FDA) to improve glycemic control in adults diagnosed with type 2 diabetes. In 2007, the FDA issued a ìblack boxî warning for Actos, a popular diabetes drug, to indicate the increased risk of congestive heart failure associated with use. When the FDA issues a black box warning, the drug company is required to indicate certain health warnings in a prominent black box within the prescribing information. These warnings are reserved for medications that have a significant risk for causing severe side effects or death. Black box warnings serve an important function because they force the drug manufacturer to be transparent and warn users of the risk of severe side effects associated with the drug.

In August 2011, the FDA issued another warning about the increased risk of bladder cancer that is associated with Actos. A 10-year study indicated that patients who take the drug for more than a year experience a heightened risk of developing Actos bladder cancer. A study published in the British Medical Journal in 2012 estimated the increased risk of developing bladder cancer was 83 percent. This substantial risk is even higher in patients who took higher doses of the drug or used Actos for more than two years. Health officials in other countries have halted the use of Actos due to this severe health risk.

The generic version of Actos was approved by the FDA in August 2012. Consumer Reports has warned patients with type 2 diabetes to steer clear of both Actos and its generic version except as a last resort.

Number of Actos Lawsuits on the Rise

Many people have been injured by severe Actos side effects. As awareness of the drugís health risks grows, more plaintiffs are filing Actos lawsuits. In most of these Actos lawsuits, the plaintiffs allege that the drugís manufacturer, Takeda, knew of the health risks but did not adequately warn doctors and patients about the potential danger. Further, they allege that Takeda did not conduct adequate safety studies before putting their product on the market. As a result, Takeda has put thousands of patients at risk. In December 2011, the U.S. Judicial Panel on Multidistrict Litigation consolidated all of the federal Actos lawsuits into the U.S. District Court for the Western District of Louisiana.

In February 2012, one former medical reviewer for Takeda alleges that she was fired after she raised concerns that the company had taken action to downplay the health risks posed by Actos. She filed a False Claim Act lawsuit, claiming that Takeda failed to report health risks to regulators. Her case is currently pending in a Massachusetts federal court.

Patients who developed bladder cancer after taking Actos to treat type 2 diabetes may be entitled to compensation. For more information, visit the Actos Bladder Cancer Class Action Lawsuit Investigation page. You can submit information about the Actos side effects that you experienced and an attorney will conduct a free case evaluation to determine whether you qualify to file a drug injury lawsuit or class action lawsuit against Takeda.

Updated April 11th, 2013

All medical device, dangerous drug and medical class action and lawsuit news updates are listed in the Drug and Medical Device section of Top Class Actions.

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