Actos is the brand name for a generic medication called pioglitazone that is used to treat type 2 diabetes. Actos is designed to be used along with exercise and dietary changes to control high blood sugar. It helps to lower blood sugar by increasing the body’s sensitivity to insulin. Actos is sometimes used in combination with other diabetes drugs.

Created and developed by pharmaceutical maker Takeda, Actos was hugely popular—in 2008 sales for Actos reached nearly $3 billion—until some serious consequences of its long-term use were discovered. Possible risks include congestive heart failure and liver failure. Extended use of Actos may also cause bladder cancer, which has been the cause of several lawsuits against Takeda.

Uses for Actos

The U.S. Food and Drug Administration (FDA) first approved Actos for treating type 2 diabetes in 1999. This type of diabetes occurs when the body becomes insensitive to insulin or stops producing enough insulin. Insulin is the hormone that regulates blood sugar. When the body stops responding to it or does not make enough, blood sugar levels get too high. This leads to serious complications.

Actos belongs to a class of medications called thiazolidinediones, which increase the body’s sensitivity to insulin. It only works for patients with type 2 diabetes, not other forms of the condition. Actos is intended to complement lifestyle changes. Losing weight, eating a better diet, and exercising more can reverse type 2 diabetes.

Actos is taken in tablet form, usually once daily. Doses are typically 15 or 30 milligrams, but may be increased over time. Treatment of type 2 diabetes is the only approved use for Actos, but it has been used in patients with fatty liver, a condition caused by alcoholism. The effectiveness for treating fatty liver with Actos is experimental.

Side Effects

The most common side effects of taking Actos are headaches, sinus infections, upper respiratory infections, pharyngitis, and myalgia, a type of muscle pain. These may be mild, moderate, or severe. If you take this medication and experience a severe form of any of these, or you get side effects that persist, you should tell your doctor. Serious side effects that require immediate medical attention include difficult, painful, or frequent urination, cloudy or bloody urine, changes in vision including loss of vision, and back or abdominal pain.

There are a couple of other concerns that have led to warnings on Actos labels. Studies with Actos have also found that the drug may be to blame for damage to the liver in some patients. The connection is not perfectly clear, but research could not rule out Actos as a cause. Another possible adverse reaction is bone fractures in female patients taking Actos. Women in studies taking the medication experienced more fractures in their hands, feet, and upper arms as compared to a control group and men taking Actos.

Congestive Heart Failure

In addition to the above side effects, there are a few other adverse reactions that some people have experienced when taking Actos. These can be serious and cause lasting complications. One of these that has caused the most concern, and eventually led the FDA to require it be placed on Actos labels as a black box warning, is the potential risk of congestive heart failure.

Actos was on the market for several years before this possibility was recognized. The black box warning was added in 2007. It states that Actos may cause or worsen congestive heart failure in patients taking the medication. It also says that the drug is not indicated for anyone with symptoms of heart failure. Anyone taking Actos should be aware of warning signs of heart failure, including edema, or swelling, quick weight gain, and labored breathing. It is thought that Actos causes fluid retention, which is what triggers or makes heart failure worse in certain people.

Bladder Cancer

The most recently discovered adverse effect of taking Actos is an increased risk of developing bladder cancer. This has been a cause of multiple lawsuits against manufacturer Takeda. Patients who have developed cancer after using Actos claim that the company knew about the risk. During lawsuits, witnesses testified to this lack of communication about a major risk. Emails were found from 2005 that indicated Takeda knew bladder cancer could be a potential problem with Actos. The emails came from various levels of management within the company.

The label for Actos now includes a warning about bladder cancer. It states that evidence from preclinical and clinical trials, and other studies, demonstrate there is an increased risk of developing cancer for patients taking the medication. Later studies, after clinical trials, found that the risk increases the longer someone is taking the drug. Actos is now contraindicated for use in patients with a history of bladder cancer or an increased risk for it.  

Actos Lawsuits

Lawsuits have been filed against Takeda because of the risk to patients for developing bladder cancer and the evidence that the company knew about, but did not communicate the risk. There is also a potential for lawsuits for patients who suffered from heart failure or liver damage. Evidence may be forthcoming that Takeda knew more about these adverse effects as well. Individuals have already received settlements for lawsuits about bladder cancer.

Takeda agreed in 2015 to release funds to cover all current product liability lawsuits, to the tune of $2.7 billion. The company is still refusing to admit liability in the case, but are willing to settle the lawsuits anyway. The settlement is one of the largest in U.S. history for prescription drugs. It will cover about 9,000 separate cases.

If you have taken Actos to treat type 2 diabetes and suffered adverse reactions that you believe were related to the drug, you may have a case for a lawsuit. Especially important to report are cases of bladder cancer, liver damage, and heart failure. These conditions are serious and can be life-altering or even life-threatening. If you have suffered from any of these because of your medication, you could be eligible for settlement funds. Contact a lawyer today to make your case.