A class action investigation has been launched against Takeda Pharmaceuticals after several studies indicated there may be a correlation between bladder cancer and diabetes medication.

The type-2 diabetes drug in question is Actos (pioglitazone), with Takeda releasing the results of a study that indicated a correlation between bladder cancer and diabetes medication.

An alleged link between bladder cancer and diabetes medication options is a troubling correlation for the growing patient population. Type-2 diabetes is one of the most prevalent health concerns in the United States, with millions of people currently contending with the disease.

Type-2 diabetes occurs when the body becomes unable to produce sufficient insulin levels, which is necessary for the body’s metabolic process. Without sufficient insulin levels, the body is forced to metabolize fat instead of sugar and makes the blood dangerously acid.

This can cause potentially fatal reactions like diabetic ketoacidosis or kidney failure, with patients also having to worry about other serious diabetic complications like ulcers and amputation.

Actos is supposed to prevent these symptoms and help patients live a normal life, but its reported correlation with bladder cancer has left many concerned. Actos works by reducing the amount of glucose made in the liver and decreases insulin resistance, helping to lower blood sugar levels.

This ultimately helps the body filter out excess blood sugar and helps prevent diabetic symptoms. However, the FDA warned against a bladder cancer and diabetes medication correlation in 2016, stating the type-2 diabetes drug may increase the chances of the disease.

Overview of Actos Bladder Cancer Correlation

The FDA warning was a followup of an earlier warning from June 2011, in which the FDA stated that taking Actos for over one year may increase the risk of bladder cancer.

Later, in August 2011, the FDA requested that Takeda include a warning of a potential bladder cancer and diabetes medication link after reviewing the results of a 10-year study. While the agency had gotten the results at the five-year mark in the 10 year study, the provisional results were still considered very troubling.

According to the provisional results, Actos patients were experiencing an increased risk of bladder cancer, and the chances further increased in patients taking higher dose prescriptions. These results reflect another study that also found that the risk of bladder cancer became higher as the Actos prescriptions became longer.

These studies spurred the FDA into making the updated warning in 2016, stating 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.”

Even though bladder cancer is a potentially fatal complication, patients allege Takeda allegedly failed to warn the general public in a timely manner. Previously in 2015, Takeda Pharmaceuticals agreed to pay $2.4 billion in a mass Actos settlement to resolve thousands of bladder cancer and diabetes medication claims.

There were approximately 9,000 Actos bladder cancer lawsuits pending at the time, each of which alleged Takeda either knew or should have known about the potential correlation.

Current or past Actos patients who developed bladder cancer may be eligible to file legal action against Takeda Pharmaceuticals.