Actos Side Effects FAQs

Q: What is type 2 diabetes?

Diabetes is a common disease characterized by the human body's struggle to produce and absorb insulin (commonly referred to as "blood sugar"). By far the most common form is type 2 diabetes, affecting 90% of the 26 million Americans with diabetes. Its chief characteristic is an elevated blood sugar level.

While diabetes has no cure and can lead to serious health problems, it is treatable. Regularly monitoring blood sugar levels is essential to managing the disease. Most patients can rely on diet and exercise to control their blood sugar levels and live normal, happy lives. Diabetes medications may also be able to lower blood sugar levels. This is the promise of Actos and similar medications.

Q: What is Actos?

Actos (Pioglitazone Hydrochloride) is a prescription medication for treating diabetes. Manufactured by Takeda Pharmaceuticals, it's part of a class of similar diabetes medications called thiazolidinediones. Actos is designed to help tissue absorb insulin circulating through the blood supply. The failure of tissue to absorb insulin is called "insulin resistance," and is one of the main causes of diabetes. After debuting on the American market in 1999, Actos brought in billions of dollars a year for Takeda Pharmaceuticals. Recently, concerns about Actos side effects have depressed sales and prompted government warnings and lawsuits.

Q: What should I know about Actos?

You should be aware of a number of Actos side effects. Studies have linked Actos to an increased risk of bladder cancer and an increased risk of heart failure (more on these two concerns below). Patients may also suffer from other serious Actos side effects including:

• Chest pain
• Decreased urine output
• Dilated neck veins
• Extreme fatigue
• Irregular breathing
• Irregular heartbeat
• Teeth problems
• Shortness of breath
• Swelling of the face, fingers, feet, or legs
• Tightness in the chest
• Trouble breathing
• Weight gain
• Wheezing
• Unexplained pain or swelling in the arms or legs
• Pale skin
• Unusual bleeding or bruising
• Unusual tiredness or weakness

Q: Does Actos increase the risk of bladder cancer?

Numerous medical studies have found an association between taking Actos for long periods of time and an increased risk of bladder cancer. This association has prompted several countries to take action. The U.S. Food and Drug Administration (FDA) warned the public about this risk in August 2011 and ordered Takeda Pharmaceuticals to update the warnings and precautions on Actos's label accordingly. Other countries have gone further. France and Germany banned the use of Actos in September 2011. Lawsuits against Takeda Pharmaceuticals have been decided against the company as well. In April 2014, a Louisiana jury returned a verdict finding that Takeda knew about and concealed the risk of cancer from consumers taking Actos.

Q: Does Actos increase the risk of heart failure?

The FDA has ordered Takeda Pharmaceuticals to place a so-called "black box warning" about the risk of heart failure on the label of Actos. This is the strongest form of warning that can appear on a drug label in the United States. It came after several clinical trials and medical studies found an association between thiazolidinediones and heart failure. Some diabetes patients experienced rapid weight gain, shortness of breath, and edema after starting drug therapy. These are all warning signs of heart failure. Some patients have reportedly died after taking thiazolidinediones such as Actos.

Q: Has Actos been recalled in the United States?

The increased risks of bladder cancer and heart failure have prompted the FDA to issue warnings and conduct further reviews of Actos's safety. However, the drug remains available to American patients. Many continue to take Actos under the careful supervision of their doctor. FDA warnings typically inform doctors and patients about the risks of a particular drug and leave further decisions up to them. This is the case with Actos.

Q: Where can I get a legal evaluation of my Actos claim?

If you have concerns or think you may be suffering from Actos side effects, speak with your doctor. If you or a loved one suffered an injury after taking Actos, you can have the facts of your situation reviewed by an attorney. Then, you can go back to focusing on your health and recovery.