Actos® (pigolitazone) Linked to Bladder Cancer

Stueve Siegel Hanson is investigating the prescription drug Actos related to an increased risk of bladder cancer.  Actos (pigolitazone) is a type 2 diabetes drug manufactured by Takeda Pharmaceuticals. It is taken orally and helps control blood sugar levels. Actos is sold in several variations, including Duetact, Actoplus Met, and Actoplus Met XR. Actos is a pill available in fifteen, thirty, or forty-five milligram versions.

Actos is prescribed to patients who have trouble regulating their blood sugar with diet and exercise alone. It may be used alone or with other medicines, including insulin and metformin.

Patients with type 2 diabetes cannot make enough insulin, and the cells of their body respond less to the insulin that is produced. Since insulin is the hormone that stimulates cells to remove glucose from the blood, the reduced amount of insulin and its reduced effect cause cells to take up less glucose from the blood and the level of glucose in the blood to rise. Actos often is referred to as an "insulin sensitizer" because it attaches to the insulin receptors on cells throughout the body and causes the cells to become more sensitive (more responsive) to insulin. As a result, more glucose is removed from the blood, and the level of glucose in the blood falls. At least some insulin must be produced by the pancreas in order for the drug to work. Actos is also designed to lower the level of glucose in the blood by reducing the production and secretion of glucose into the blood by the liver. In addition, the drug may alter the blood concentrations of lipids (fats) in the blood. Specifically, it decreases triglycerides and increases the "good" (HDL) cholesterol.  Unfortunately, there is no cure for diabetes so Actos must be taken regularly.

In August 2011, the U.S. Food and Drug Administration (FDA) informed the public that "the agency has approved updated drug labels for Actos (pigolitazone) to include information that the use of this medication for more than 12 months may be associated with an increased risk of bladder cancer." 

While the FDA has yet to issue an Actos recall, all eyes are on the drug's manufacturer, Takeda Pharmaceuticals. Even before the drug was released to the market, Takeda noted a link between Actos and bladder tumors in male rats. Since that connection was made, the FDA required Takeda to launch a 10-year investigation study using humans. The first five years of the study, using nearly 200,000 patients both taking Actos and a placebo, found that those taking Actos for longer than a year have a 40% higher risk for developing bladder cancer. About the same time, French researchers conducted a similar study and found similar results.

Because of these results, drug regulators in France, Germany and Canada pulled the drugs from the shelves and restricted its use. In the U.S. and England, drug regulators issued harsh warnings and insisted on further studies. The final results of the U.S. study are expected in 2013.

Given the potential risk of those taking Actos of contracting bladder cancer, becoming familiar with the symptoms of bladder cancer can be an important step toward safeguarding your health.  The most common symptoms of bladder cancer develop quietly in a majority of people with the disease.  Bloody urine is one of the most frequent first signs of the disease. This symptom, however, is usually painless and most patients are either unaware of it or ignore it. Bladder cancer can also cause frequent urination, urinary tract infections and unexplained weight loss. It's known as a recurrent cancer, which means if you get it once, there's a likelihood it will return.

Bladder cancer is a serious condition, which attacks the lining of the bladder.  It affects nearly 70,000 and kills almost 15,000 people each year in the United States. However, the survival rate is very high if discovered early. 
Treatment of bladder cancer often involves chemotherapy, surgery, vaccine therapy, immunotherapy or radiation therapy, which can take years and require lifetime check-ups. 

Due to the failure of Takeda Pharmaceuticals to properly warn patients of the danger of their drug, or to voluntarily issue an Actos recall, they may be liable for the damages caused.

If you or someone you know has experienced serious side effects, including bladder cancer, caused by Actos and wish to receive additional information about your legal options, please call 1-888-756-6494 or fill out the form on this page.


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