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A Woman Files Suit Against Actos After Being Diagnosed With Bladder Cancer

One of the many new lawsuits against manufacturer Takeda Pharmaceuticals, Inc. was filed by Pennsylvania resident Mona Marie Rolls. The case alleges she developed bladder cancer resulting from Actos. Plaintiff Rolls seeks to hold the defendant liable for her injuries and filed the case on July 27, 2012, in the Circuit Court of Cook County, Illinois. Rolls brings counts of strict liability and negligence against the defendants. She states that the manufacturer failed to ensure the product was accompanied by proper and accurate warnings about the possible adverse side effects.

Unaware of the connection, the plaintiff continued taking Actos even after her bladder cancer diagnosis

In her complaint, Rolls states that she started taking Actos around July 2008 and that year, the drug had become the tenth best-selling drug in the United States. Actos was prescribed by her physician for long-term maintenance of her Type II diabetes. At the time, there were no warnings on the drug’s label about any risk of bladder cancer, and Rolls states that she and her doctor were unaware of such risks, nor could they have reasonably known about them.

According to her Actos attorneys, Rolls was diagnosed with bladder cancer in around May, 2009—about a year after she started taking the medication. Still unaware of the connection between the medication and bladder cancer, she continued taking the medication until March of 2010.

As a result of ingesting the drug for many years, Rolls claims, she has been permanently and severely injured, and will require ongoing medical care and treatment. She states that the defendants were aware of the cancer risk from the drug, yet failed to warn physicians or patients. She points out a two-year animal study performed prior to the FDA’s approval of Actos indicated drug-induced tumors.

France suspends the use of Actos and the FDA issues a second warning

In 2005, the results of the PROactive clinical trial found a higher percentage of bladder cancer cases in patients using Actos versus competitors.

In September 2010, shortly after Rolls stopped taking Actos, the FDA issued a Safety Announcement stating it was reviewing data from an ongoing study to evaluate the association between Actos and cancer.

Meanwhile, in early 2011, the American Diabetes Association published a study concluding that that there was an association between Actos and the disease. Then, on June 9, 2011, the European Medicines Agency announced that it had been informed by the French Medicines Agency of its decision to suspend the use of Actos and other pioglitazone-containing medicines in France. About a month later, France implemented a recall of Actos, totally withdrawing the drug from the market because of studies linking it to bladder cancer.

The FDA issued a second safety announcement warning to doctors and patients on June 15, 2011. It warned of an increased risk of bladder cancer in those taking Actos for more than a year. For the first time, this warning was added to the label of Actos.

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