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Actos Lawsuit Alleges Inadequate Warnings

Actos LawsuitOn February 19, 2013, plaintiffs Stephen Tantillo and Margaret Tantillo filed an Actos lawsuit against Takeda Pharmaceuticals. The case is currently proceeding in the U.S. District Court in the Western District of Louisiana under Judge Doherty. The plaintiffs, who are New Jersey residents, allege that Stephen Tantillo developed bladder cancer after taking the drug, Actos, which was developed and marketed by Takeda. This lawsuit joins a growing number against the pharmaceuticals company, which cites links between the drug and bladder cancer.

Actos (pioglitazone) is a medication intended for the treatment of type 2 diabetes. It is a type of drug called a thiazolidindione drug (TZD). It works by managing a patient’s blood sugar levels, and it may sometimes be prescribed in conjunction with insulin. However, in clinical studies, Actos has been linked to an increased risk of bladder cancer and heart failure.

Actos lawsuit alleges adverse side effects

Plaintiff Stephen Tantillo was prescribed Actos in 2009, and he used the drug from 2009 to 2011. In March 2011, the plaintiff was diagnosed with bladder cancer. Even patients who have successfully managed to go into remission from bladder cancer are likely to experience a recurrence of the disease at a later date. This results in the need for follow-up diagnostic tests on an ongoing basis for years after the initial diagnosis. Typically, bladder cancer can result in complications such as:

  • Bloody urine
  • Frequent and painful urination
  • Back pain
  • Pelvic pain
  • Death

According to the complaint, as a result of his diagnosis of bladder cancer, the plaintiff has sustained and will continue to sustain permanent injuries. The complaint alleges significant pain and emotional trauma, along with the need for ongoing medical care.

Studies reveal Actos bladder cancer risk

Several clinical studies have given weight to the Actos bladder cancer risk. This Actos lawsuit describes a two-year study on rats prior to the drug’s FDA approval. The study results noted drug-induced tumors in the male rats that received Actos. And in 2005, a three-year study was published that further substantiated the link. The research was designed to assess cardiovascular side effects; however, the results noted that patients who received Actos were also much more likely to develop bladder cancer. The same results were seen in a separate three-year study that was designed to assess side effects on the liver.

The FDA took a closer look at the risk of bladder cancer amongst Actos users. The agency evaluated the information from the first five years of a ten-year study on Actos, which was conducted by Takeda. By this point in the study, the results indicated that patients taking Actos were at a 40 percent increased risk of developing bladder cancer.

This information led to the Actos FDA warning, which was issued on June 15, 2011. This safety communication cautioned that patients who used Actos for more than a year, which includes the plaintiff, Stephen Tantillo, were at a much greater risk for bladder cancer. The FDA also ordered that the safety information for the drug be updated to reflect this risk.

Other countries have also taken note of the potentially life-threatening complications of Actos. On June 9, 2011, France announced that it was suspending all sales of medications containing pioglitazone. The announcement was based on a “statistically significant increase” in bladder cancer risk. Germany followed suit the very next day.

Actos lawyer alleges inadequate warnings

According to the Tantillo complaint, the Actos lawyer alleges that Takeda failed to adequately warn patients and doctors about the risks associated with Actos use. The lawsuit also claims that Takeda concealed and has continued to conceal their knowledge of the “unreasonably dangerous risks.” These allegations echo those of previous lawsuits filed against the company.

As a result, the plaintiff seeks compensatory damages for pain and suffering, as well as reimbursements for attorneys’ fees and costs, ascertainable economic losses from lost wages, the cost of the drug itself, and all past and future medical expenses related to the drug.

2011 FDA Safety Communication on Pioglitazone and Bladder Cancer