Pioglitazone (brand name Actos) is a type of diabetes drug used to control blood sugar in those with type-2 diabetes, and is manufactured by Takeda Pharmaceuticals. However, while the type-2 diabetes drug pioglitazone is a popular option, studies have unfortunately shown an increased risk of bladder cancer with pioglitazone users.

What is Pioglitazone?

Pioglitazone is part of a class of drugs known as thiazolidinediones that is used to treat type-2 diabetes. Type-2 diabetes is characterized by insulin resistance, or when the body does not use insulin effectively. This causes the elevation of a person’s blood sugar.

It was approved by the U.S. Food and Drug Administration (FDA) back in 1999, and works to regulate high blood pressure by adjusting the body’s response to insulin and control blood sugar. Lowering blood sugar by using pioglitazone in conjunction with proper diet and exercise can help a patient avoid some of the dangerous symptom of diabetes. Diabetes drugs like pioglitazone help protect diabetes patients from problems like kidney damage, blindness, nerve damage, sexual function problems, loss of limbs, heart attack, and stroke. 

Since its introduction to the market, Actos has become an increasingly popular option for treating type-2 diabetes. In 2010 alone, sales of Actos brought in more than $2.6 billion.

Pioglitazone is taken daily, and is used either by itself or in combination with other diabetes drugs, explains WebMD.

What Are the Side Effects of Pioglitazone?

Any medication comes with certain side effects, and pioglitazone is no exception. Side effects of pioglitazone can include sore throat, muscle pain, weight gain, and tooth problems. More severe problems include vision problems, bone fracture, reddish-colored urine, or pain wile urinating.

In rare cases, pioglitazone use has been linked to liver disease. Some early symptoms of liver disease include dark urine, yellowing of eyes and skin, pain in the stomach and abdomen, and persistent nausea or vomiting. Happily, severe allergic reactions to the drug are rare. 

Is There a Risk of Bladder Cancer with Pioglitazone?

Takeda Pharmaceuticals, the manufacturer of pioglitazone, was conducting a ten-year prospective study on the drug’s possible association with bladder cancer. At the five-year mark for the study, researchers found an increased bladder cancer risk linked with use of pioglitazone.

Since that study’s results were published, additional research into pioglitazone have shown conflicting data on two counts: first, on whether or not pioglitazone is associated with an increased risk of bladder cancer at all, and second, whether either the duration or dosage of the drug can influence that risk. The results of Takeda’s full ten-year study, for instance, showed weaker connections between pioglitazone and bladder cancer than the results of the results they pulled at the halfway point.

In another study, researchers found both statistically significant numbers of patients who developed bladder cancer as well as an increased risk based on duration and dosage of the drug’s use.

Indeed, the results of these studies led the FDA to include warning labels about the potential risk for bladder cancer with pioglitazone use in August 2011. That same year, Europe removed pioglitazone from the market.

In 2016, the FDA reaffirmed this bladder cancer risk in an updated safety announcement.

Other countries’ regulatory agencies have responded more drastically to the possible connection between pioglitazone and bladder cancer. France has already discontinued the use of pioglitazone over concerns art the drug could be linked to bladder cancer. This decision was made based on information from a study done nay the French National Health Insurance. For its part, Germany’s Federal Institute for Drugs and Medical Devices advised doctors against prescribing the drug until more research had been conducted that can shed more light on the drug’s link to bladder cancer.

Can I File a Pioglitazone Lawsuit?

If you or someone you love have suffered from pioglitazone complications like bladder cancer, you may be able to file a lawsuit and pursue compensation. Of course, filing a lawsuit cannot take away the pain and suffering caused by side effects like bladder cancer, nor can it bring a loved one back to life, but it can at least help to alleviate the financial burden incurred by medical expenses, lost wages, and more.

Filing a lawsuit can be a daunting prospect, so Top Class Actions has laid the groundwork for you by connecting you with an experienced attorney. Consulting an attorney can help you determine if you have a claim, navigate the complexities of litigation, and maximize your potential compensation.