As type 2 diabetes has been on the rise in the U.S. so too have the number of medications developed to treat it. Actos is an early example and was first approved by the U.S. Food and Drug Administration (FDA) in 1999. It is the generic drug pioglitazone and it treats type 2 diabetes by lowering blood sugar and is designed to be used along with exercise and healthy diet habits.
Actos side effects have proven to be serious in many instances, and have led to lawsuits against drug maker Takeda Pharmaceuticals. People who took the medication and suffered from liver damage, bladder cancer, heart failure, and other life-threatening conditions felt they were not warned of these side effects. Many lawsuits have found in favor of plaintiffs because of the severity of the side effects and the proven negligence of the drug maker.
Actos and Type 2 Diabetes
Type 2 diabetes occurs when lifestyle habits like poor diet and lack of exercise lead to chronically high blood sugar levels. This happens because the body becomes less sensitive to the hormone insulin, which is excreted by the pancreas to control blood sugar. In some people production of the hormone may also decrease with type 2 diabetes.
Reversing those bad lifestyle habits by eating well, exercising more, and losing weight can reverse the health condition, but people also benefit from supplementing these changes with a medication. Many doctors recommend this because lifestyle changes alone reverse the course of the disease slowly. In the meantime, the complications of high blood sugar can have a serious and negative impact on health.
Actos, or pioglitazone, is a type of medication called a thiazolidinedione. It works by increasing sensitivity to the insulin excreted by the pancreas and thereby lowering blood sugar levels. When the FDA approved pioglitazone in 1999 the agency recommended that it be used along with lifestyle changes. Just taking the medication is not good enough to make lasting positive health changes.
Typical Side Effects
Actos side effects range from common and not worrying to less common and so severe as to be life-threatening. In most patients, Actos is well tolerated and may cause side effects like upper respiratory infections, headaches, sinus infections, and pharyngitis. It may also cause a type of muscle pain called myalgia. Most of these never become serious and may actually diminish or totally disappear over time. There are, however, several other side effects that have the potential to be much more serious.
Liver Failure and Kidney Disease
One of these is liver damage and even liver failure in some cases. People with liver damage, with liver disease, or with any history of liver problems are cautioned against using Actos, which illustrates how serious this potential side effect can be. Even people without previous liver damage are expected to have their liver enzymes monitored regularly while on Actos. Cases of jaundice, hepatitis, and even liver failure, which can be deadly, have been reported in people using the medication.
In addition to damage to the liver, Actos has been shown to also present a threat to the kidneys. In one study eight percent of participants using the drug experienced chronic kidney disease as a side effect. This even occurred in patients who were using lower doses of Actos and were on it for no more than one year. The study included thousands of patients and a representative sample.
The liver and the kidney are not the only organs that may be impacted by Actos. The heart is also vulnerable and side effects related to the heart can quickly become deadly. The risk of heart failure while on Actos led to a black box warning requirement by the FDA, the type of warning reserved for the most severe side effects of medications.
The warning was added in 2007, eight years after Actos was first approved, and states that in patients with any degree of congestive heart failure should be cautious when using the drug. It has been proven to worsen cases of existing heart failure. Patients with edema are also at a greater risk of developing heart failure because Actos may worsen the swelling and fluid retention, which directly contribute to the heart condition. Anyone with any symptoms of heart failure should not take Actos, and any signs of the condition while using the drug should be taken seriously.
One of the most serious of all Actos side effects is bladder cancer. It is a recent discovery that the diabetes drug may cause this type of cancer and it has also led to a number of lawsuits. People who developed cancer felt that this risk should have been known earlier and communicated to patients and doctors. In fact, there is evidence that Takeda knew about the risk of bladder cancer and actively failed to warn the public or to notify the FDA. The result of this negligence was $2.7 billion in a huge settlement for thousands of patients.
Now that the risk is known the labels for Actos contain a warning about bladder cancer. Unfortunately for those who suffered from this side effect the warning came much too late. Ongoing studies are finding more about the risk and seem to indicate that the longer a patient has taken Actos to control diabetes, the more likely he or she is to develop bladder cancer.
If you took Actos and suffered from any of the side effects, you may have experienced uncomfortable symptoms that became life-threatening or that left you with lifelong complications. You may even have lost a loved one to some of these Actos side effects, like heart failure. Side effects like those caused by Actos can not only ruin your health; they may also impact your finances, your job, and your relationships. Like other people who suffered in this way, you may feel that Takeda was to blame and you may want to file a lawsuit. A lawyer can help you decide if your side effects are severe enough to help you make a good case for compensation.