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Despite Bladder Cancer Lawsuits, FDA Approves Generic Actos

August 21, 2012 – Amid growing concerns over Actos’s potential to cause bladder cancer in certain users, last week the U.S. Food & Drug Administration (FDA) approved the first version of Takeda’s widely-prescribed type 2 diabetes drug. The administration granted Mylan Pharmaceuticals permission to manufacture and market generic Actos (pioglitazone) in 15, 20 and 45 mg. strengths. The new generic version will carry the same warnings placed on name brand labels, including a boxed warning that the drug may cause or worsen heart failure and bladder cancer.

Actos Bladder Cancer Lawsuit Update April 8, 2014: In the first U.S. trial of its kind, Takeda Pharmaceuticals and Eli Lilly were ordered to pay a total of $9 billion in punitive damages after a jury agreed that the companies failed to warn the public and medical communities about the bladder cancer risk associated with their controversial type 2 diabetes drug Actos (pioglitazone). The lawsuit claimed that Takeda and Lilly downplayed or ignored concerns about Actos’ link to bladder cancer, and mislead health authorities in order to protect profits. Click here to learn more.

Free Actos Lawsuit Evaluation: If you or a loved one has been injured by Actos, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of Actos and we can help.

What’s the problem?

Actos (pioglitazone), a drug developed by Takeda Pharmaceuticals, is a once daily pill for the treatment of type II diabetes. The drug, approved by the FDA in July 1999, increases the body’s sensitivity to insulin. Medications with similar active ingredients to Actos include ActoPlus Met and Duetact.

In September 2010, concerns began to surface linking Actos to bladder cancer after the FDA began investigating interim results from long-term clinical trials. These results revealed that Actos users had an increased incidence in bladder tumors. The FDA investigation spawned further studies, and later that year a French Insurer linked active ingredients in Actos to bladder cancer. Results from the French study led to Actos being recalled in France and Germany, and Black Box warnings in other countries.

Currently, Takeda is facing product liability lawsuits from American Actos users who have been diagnosed with bladder cancer after using the drug. These consumers claim that for over ten years, Takeda failed to provide risk warnings regarding the long-term use of Actos, and that the current warnings remain insufficient, particularly for a drug that has been recalled throughout Europe.

Earlier this summer, another study was released regarding the effect of the duration of Actos usage on bladder cancer risk. The study concluded that individuals who had taken pioglitazone for one to five years had twice the risk of developing bladder cancer when compared to non-users. Long-term users, those with a usage greater than five years, had triple the risk.

All federal Actos lawsuits have been centralized as part of a multidistrict litigation (MDL), which is currently consolidated in the Western District of Louisiana before District Judge Rebecca Doherty. The first Actos trials are not slated to begin until November 2014 and January 2015.

Do I Have an Actos Lawsuit?

The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Actos lawsuits. We are handling individual litigation nationwide and currently accepting new injury cases in all 50 states.

Free Actos Lawsuit Evaluation: If you or a loved one has been injured by Actos, you should contact our law firm immediately. You may be entitled to compensation by filing an Actos side effects suit and we can help.

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