Takeda Pharmaceuticals is facing a new Actos bladder cancer lawsuit, which alleges the type-2 diabetes treatment medication caused the claimant to develop this deadly condition.

The Actos bladder cancer lawsuit was filed by a couple from Indiana, who alleges the pharmaceutical giant did not disclose the alleged correlation at any point before or after the claimant’s prescription.

Plaintiff Andrea E. and husband Phillip E. filed this Actos bladder cancer lawsuit alleging loss of consortium, stating the medication’s side effects permanently impacted their marriage.

The complaint says that like many other type-2 diabetes patients, Andrea was prescribed Actos in 2008 to help maintain healthy blood sugar levels and help offset some of the more severe diabetes symptoms.

According to the Actos bladder cancer lawsuit, Andrea had used the medication according to prescription instructions for years but had developed potentially fatal injuries. Andrea says she was diagnosed with bladder cancer in December 2016 and has been contending with the long term effects of the disease ever since.

Andrea and Phillip opted to file this Actos bladder cancer lawsuit soon after discovering other patients had developed similar injuries, and there were early results of a 10 year safety study indicating a correlation.

Overview of Actos Bladder Cancer Correlation

Actos was approved by the FDA in July 1999, and is part of the insulin sensitizing medication group known as thiazolidinediones (“TZDs”). Actos is typically prescribed to type-2 diabetes patients that have particular trouble with maintaining healthy blood sugar levels, which also helps the body with insulin sensitivity.

Type-2 diabetes is one of the most prominent health problems in America affecting millions of people, who have trouble with their body’s natural insulin production. Actos is supposed to help mitigate this, which prevents serious diabetic complications like neuropathy and diabetic shock.

However, Actos has been recently correlated with bladder cancer in the preliminary results of a 10 year study which prompted the first FDA warning in June 2011. This initial warning stated that patients who are prescribed Actos for over one year may face an increased risk of bladder cancer.

The FDA required Takeda to include a warning about potential bladder cancer to the medication’s warning label in August 2011, after reviewing the five-year mark results of a 10 year Actos study. The early results of the study found that patients who were on long term Actos prescriptions faced a higher risk of cancer.

The FDA recently issued a public warning in 2016, reiterating that Actos could increase the risk of bladder cancer. In this warning, the FDA stated that Actos “may be associated with an increased risk in urinary bladder cancer, and we have updated the drug labels to include information about these additional studies.”

At all times relevant, Andrea and Phillip say that Andrea only used the medication according to prescription instructions and had relied on the information provided by Takeda. Andrea states she would not have taken Actos if she had known about its alleged correlation with bladder cancer.

Andrea and Phillip are seeking damages in their Actos bladder cancer lawsuit, including counts of negligence and failure to warn.

This Actos Bladder Cancer Lawsuit is Case No. N18C-11-216 JRJ, in the Superior Court of Delaware.