Actos bladder cancer has become a significant concern with type-2 diabetes patients, and the FDA recently issued a warning regarding the correlation.

The FDA made this announcement in 2016, stating 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.”

The FDA issued this Actos bladder cancer warning after early results of a 10-year study indicated Actos patients faced a higher likelihood of bladder cancer compared to other patients. These results were analyzed at the study’s five year mark, with researchers further finding that the likelihood was higher in patients who were either prescribed high doses or those on long term Actos prescriptions.

The FDA first warned against potential Actos bladder cancer in August 2011, requiring Takeda Pharmaceuticals to mention the potential complication on the drug’s warning label. Similar to the provisional study results, the initial warning stated patients may be at risk for developing bladder cancer after one year of Actos treatment.

Overview of Actos and Bladder Cancer Correlation

Actos (pioglitazone) is a popular type-2 diabetes treatment drug, manufactured by Takeda, that helps control blood sugar levels by increasing the body’s sensitivity to insulin. When used in conjunction with diet and exercise, Actos is supposed to help minimize the chronic health complications associated with type-2 diabetes, including nerve damage and limb amputation.

Actos has been on the market since 1999, but its recent association with bladder cancer has left many patients and members of the medical community wary of the medication.

Along with the interim study results, another study also found a potential association between Actos and bladder cancer with 54 out of 10,951 patients developing the disease. Researchers also noted the statistic was higher in patients who had taken Actos for longer periods of time.

“Overall, we conclude that pioglitazone 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,” the FDA stated in their announcement.

The concern of Actos bladder cancer has already caused Takeda Pharmaceuticals to face major litigation backlash, with the company recently agreeing to pay $2.4 billion to resolve approximately 9,000 lawsuits alleging the type-2 diabetes drug had caused plaintiffs to develop permanent injuries. This 2015 settlement was one of the largest settlements for big pharmaceutical companies in the history of the United States.

At the time of the 2015 Actos settlement, the lawsuits alleged Takeda Pharmaceuticals failed to disclose the alleged correlation between their type-2 diabetes medication and deadly cancer. The lawsuits further alleged that Takeda knew about the association, but concealed this information from the public.

The lawsuits cited early Actos studies conducted on animals during the early 2000s, which may have indicated the risk early on. While Takeda agreed to pay the settlement, the company maintains their drug does not cause bladder cancer in patients. However, Takeda continues to face legal action for the alleged correlation between Actos and bladder cancer along with fellow manufacturer Eli Lilly.