Patients across the United States are concerned over a reported Actos cancer risk, after early results of a 10 year study indicate an increased risk.

The FDA has warned against a potential Actos cancer risk twice in the past decade — leaving the medical community and patient population concerned over potential drug complications.

The FDA first warned the public against a potential Actos cancer risk in June 2011, with the agency noting that patients with type-2 diabetes may face an increased risk of bladder cancer if prescribed the drug for longer than one year. The FDA asked manufacturer Takeda Pharmaceuticals to include an Actos cancer risk to the drugs warning label in August 2011, with early results indicating a significant risk.

The provisional results were analyzed midway through the five-year study, with the study showing the risk of bladder cancer increased with longer Actos prescriptions.

More specifically, the results of the study showed that patients faced over double the risk for bladder cancer if they used Actos for two years or more. The study consisted of over 115,000 people who were prescribed different diabetes treatment drugs from 1988 until 2009.

Approximately 470 patients were diagnosed with bladder cancer in five years, with research indicating Actos patients had an 83 percent increased risk of bladder cancer.

While researchers stated that developing bladder cancer is unlikely, doctors should still warn type-2 diabetes patients who are considering Actos treatment. After reviewing the provisional results of the study, the FDA issued a more recent Actos cancer risk warning in 2016.

Overview of Actos Cancer Risk Allegations

Actos was approved by the FDA in 1999, and is apart of the thiazolidinediones (TZD) drug family. This medication works by increasing the body’s sensitivity to insulin and helps prevent blood sugar levels from rising too high. With diet and exercise, Actos is supposed to help type-2 diabetes patients maintain a healthy lifestyle.

Type-2 diabetes occurs when the body fails to respond to insulin the way it should. This can result in an excess of sugar that remains in the blood.

Drugs like Actos are used to keep these blood sugar levels from getting too high. Overall, Actos is supposed to help type-2 diabetes patients have a normal life while minimizing the risks associated with the disease.

However, the recent announcements regarding an increased Actos cancer risk has left much of the patient population concerned. It is currently not known why Actos may be causing bladder cancer in some patients, but research results indicate it could be due to prolonged exposure to the drug’s ingredients.

Even though bladder cancer can be potentially fatal for patients, patients claim Takeda allegedly failed to disclose this information to patients. In 2015, Takeda had agreed to pay $2.4 billion as a part of an Actos settlement consisting of patients who allegedly developed bladder cancer from the medication.

There were approximately 9,000 Actos bladder cancer lawsuits pending at the time, each alleging that Takeda allegedly knew or should have known about the alleged correlation.