Takeda Pharmaceuticals developed and now sells the prescription drug Actos—generic drug pioglitazone—to lower blood sugar in people with type 2 diabetes. Used along with lifestyle changes and sometimes with other medications, Actos helps people with this chronic condition keep blood sugar levels under control.

Actos has been a huge seller for the company, but it has also cost Takeda billions in settlement costs. There are a couple of potentially serious and life-threatening complications that Actos can cause in some patients, including congestive heart failure and bladder cancer. There is also evidence that Takeda knew about some of these risks and marketed the drug anyway. This has led to one of the largest settlements in prescription drug history.

What is Actos?

Pioglitazone is a medication that was first approved for use by the U.S. Food and Drug Administration (FDA) in 199 for the treatment of type 2 diabetes. People with this kind of diabetes have lost sensitivity to insulin or don’t produce enough insulin anymore. Insulin is the hormone that regulates blood sugar levels. Actos is supposed to be used along with changes in diet, exercise, and weight loss,.

Actos belongs to a class of drugs called thiazolidinediones. These types of drugs help make the body more sensitive to insulin and stimulate the excretion of sugar in urine. Some research indicates that Actos may be effective in treating fatty liver, a complication of alcoholism, but it is not yet approved for that use. Actos is also not used in people with type I diabetes.

Side Effects

For many people, taking Actos has been both safe and effective and has helped them to manage their blood sugar when diet and exercise alone were not enough. On the other hand, there are some side effects caused by pioglitazone that some people experience. These include myalgia, or muscle pain, and headaches. It can also cause a number of infections including sinus infections, pharyngitis, and upper respiratory infections.

Less common are some more serious side effects like damage to the liver. It is not yet clear exactly how or why Actos affects the liver in some people, but the evidence is strong enough to warn patients of the possibility. There is also the possibility that using the drug can increase the risk of bone fractures, especially in women and in the hands, upper arms, and feet.

Congestive Heart Failure

This type 2 diabetes drug has also been proven to increase the risk of much more serious complications, which has led to Actos lawsuits for Takeda. These complications include congestive heart failure, which is a life-threatening condition in which the heart is not able to pump blood out to all areas of the body. Evidence shows that Actos can cause fluid retention, which is what may lead to worsening heart failure in patients who already have the condition or the onset of the condition in someone predisposed to it.

Because of the mounting evidence that pioglitazone puts people at risk for congestive heart failure, and possibly death, the FDA added a black box warning to Actos labels in 2007. The warning states that the medication should not be used in anyone with congestive heart failure and that anyone taking it should be monitored for the signs of heart failure.

Bladder Cancer

Another serious complication is bladder cancer. Individual reports and studies have recently discovered that taking Actos increases the risk of a patient developing bladder cancer, especially in those at risk for it and those taking the medication for longer periods of time. The risk is great enough that the label for Actos now contains a warning about bladder cancer and it is now contraindicated for anyone with a history of bladder cancer.

Actos Lawsuits

Takeda has faced Actos lawsuits mostly because of the potential risk for bladder cancer. Thousands of individuals have filed lawsuits against the company because of the damage this type of cancer has caused. A 2005 study found that there is a higher percentage of bladder cancer in patients using Actos as compared to those using other type 2 diabetes drugs. Since then there have been even more studies to back up that evidence. Plaintiffs in the cases against Takeda allege that the company knew about the risk of bladder cancer years earlier and marketed the drug anyway.

Although bladder cancer has been the main reason so far that people have filed lawsuits against Takeda, there are other potential reasons that a suit may be started. Congestive heart failure is a serious condition and if a patient feels they were not adequately warned of the risks of using Actos, they may have a case for seeking compensation, especially when that heart failure proved fatal and loved ones lost a family member. Since it has been on the market, Actos has also been proven to double the risk of bone fractures in certain patients, just another reason the company may be negligent in promoting the drug.

Record Settlement

Takeda settled the thousands of cases against it because of Actos and bladder cancer in 2015. The settlement was one of the largest in the history of prescription drug settlements. The win for the plaintiffs came down to evidence that proved Takeda knew of the risk. Witnesses in the case cited emails from 2005 that show Takeda management knew about the risk and discussed whether or not to include it as a warning on the drug label. The evidence is clear that the company put sales ahead of patient safety and as a result Takeda settled for $2.7 billion.

Compensation from Lawsuits

If you took Actos and suffered serious complications, whether that was bladder cancer, congestive heart failure, or other health problems, you may want to consult a lawyer to find out what your options are. There are many reasons why people file lawsuits against companies like Takeda. One is to seek punitive damages. This means that a company is fined as punishment for misleading the public.

Other reasons to file a lawsuit include getting compensation to help with expenses related to your health problems caused by the medication. Serious side effects from drugs may cause you to lose income when you can’t go to work, pay exorbitant medical bills, and generally suffer and experience pain. All of these are valid reasons to ask for compensation. If you aren’t sure how to get started, contact a lawyer for advice.