Takeda Pharmaceuticals is facing a new Actos lawsuit, alleging the type-2 diabetes medication caused the claimant to develop bladder cancer. The Actos lawsuit was filed by a couple from Texas, who alleges the medication was prescribed to the husband for typical treatment purposes and that they knew of no reason to believe he was at risk for any serious complications.

This Actos lawsuit was filed by plaintiff John J. and his wife Mary J., who contend the treatment mechanism of the diabetes medication significantly increased John’s risk of bladder cancer.

The couple says that like millions of other type-2 diabetes patients, John was prescribed Actos to help manage his blood sugar levels and helps mitigate serious diabetic symptoms. Actos is part of the thiazolidinedione (TZD) drug class, that work by helping the body process excess sugar.

This medication has been on the market since July 1999, according to the Actos lawsuit, and has been prescribed to numerous patients. However, it has recently been discovered that Actos significantly increases the risk of bladder cancer development in patients who take the medication for over 12 months.

According to the Actos lawsuit, John had ingested the diabetes medication for over 12 months in accordance with his prescription instructions, then developed bladder cancer. John says he continues to suffer and has undergone intense treatment methods.

While contending with the disease, John alleges he discovered that numerous other patients allegedly developed similar health problems.

Overview of Actos Bladder Cancer Correlation

Before Actos was approved, a two year study was conducted to determine if there were any carcinogenic side effects associated with the type-2 diabetes medication. The results were released from the study in 2005, revealing a significant correlation between Actos and bladder cancer.

In September 2010, the Food and Drug Administration (FDA) announced that it would be reviewing the results from a ten year bladder cancer study. The data has already shown that the alleged correlation between Actos and bladder increased based on the dosage amount and treatment time, especially if the treatment time exceeded 24 months.

The FDA first warned the public against Actos bladder cancer in June 2011, stating that patients are more likely to develop the disease after more than one year of use of the diabetes medication.

The FDA also asked Takeda Pharmaceuticals to mention reports of bladder cancer on the drug’s label in August 2011, based on the provisional results of a 10 year study reviewed at the five year mark.

Another study found an increased risk of bladder cancer in conjunction with long term Actos use. These studies eventually spurred the FDA to make another announcement regarding Actos in 2016, stating the drug “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.”

According to the Actos lawsuit, Takeda failed to disclose alleged correlation between Actos and bladder cancer to the public. John states he would not have agreed to take Actos if he had known he faced an increased risk of bladder cancer.

John and Mary are seeking multiple damages in their Actos, including negligence and loss of consortium.

This Actos Lawsuit is Case No. 1:18-cv-00474, in the U.S. District Court of Eastern Texas.