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Duetact Lawsuit

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Duetact is an anti-diabetic medication containing two drugs (pioglitazone / glimepiride), which treat Type-2 Diabetes in adults by stimulating the pancreas to produce more insulin, while simultaneously increasing the body’s sensitivity to insulin. Unfortunately, new research has linked pioglitazone to a 40% increased risk of developing bladder cancer. Serious cardiovascular events have also been linked to Duetact, including congestive heart failure, heart attack, and stroke.

What is Duetact?

Duetact (pioglitazone and glimepiride) is an oral medication used with diet and exercise to control blood sugar levels in adults with Type-2 Diabetes who do not take insulin injections. Duetact is manufactured by Takeda Pharmaceuticals, and was approved by the U.S. Food and Drug Administration (FDA) in 2006.

Duetact comes in two strengths (30-mg pioglitazone, 2-mg/4-mg glimepiride). It is a combination of two anti-diabetic medications:

Pioglitazone is an anti-diabetic medication, also sold under the brand-name Actos, Actoplus Met, and Actoplus Met XR. It belongs to a class of anti-diabetic medications known as thiazolidinediones (TZDs), which works mainly by decreasing the body’s resistance to insulin. It also improves sensitivity to insulin in the body, and inhibits the liver’s production of glucose (sugar). It improves blood-sugar control while reducing the amount of insulin that is circulating in a diabetic’s bloodstream.

Glimepiride is an anti-diabetic medication, in a class of drugs known as sulfonylureas. These medications work by lowers blood sugar by causing the pancreas to produce more insulin and helping the body use the insulin more efficiently. It also increases the activity of intracellular insulin receptors, making cells more sensitive to insulin in the body. Because this medication works by increasing the amount of insulin the body produces naturally, it is not used in people with Type-1 Diabetes, a condition in which the body does not produce insulin.

Type-2 Diabetes is a lifelong metabolic disorder characterized by high blood sugar and insulin resistance. Whenever a person eats food, the liver metabolizes the food and turns it into glucose (sugar), which is dissolved in the bloodstream. At the same time, the pancreas secretes a hormone called insulin into the bloodstream. Insulin tells cells in your muscles, fat, and other tissue to stop using reserved energy sources and start taking up the glucose in the bloodstream. When a person has Type-2 Diabetes, the cells are insulin-resistant. This means that they do not respond very well to insulin, and they do not take up as much blood sugar as they should, causing chronically high blood sugar levels. Type-2 Diabetes is a growing epidemic in the U.S., with around 24 million people suffering from this disorder, and nearly 25% unaware that they have diabetes.

Duetact and Bladder Cancer

When the FDA approves new types of drugs for use in the United States, they usually require that the drug manufacturer conduct post-marketing safety surveillance to monitor for unexpected side effects. To meet this requirement, Takeda Pharmaceuticals is currently in the midst of a ten-year analysis regarding the safety of pioglitazone, an ingredient in Duetact. At the half-way point, the FDA reviewed preliminary results. They found that, compared to the general population, the rates of bladder cancer were 40% higher in people who had taken pioglitazone for at least one year.

In response the FDA published a new Drug Safety Communication in June 2011, and issued the following statement:

“Compared to never being exposed to pioglitazone, a duration of pioglitazone therapy longer than 12 months was associated with a 40% increase in risk . . . Based upon this data, FDA calculated that duration of therapy longer than 12 months was associated with 27.5 excess cases of bladder cancer per 100,000 person-years follow-up, compared to never using pioglitazone.”

Though an extra 30 cases of bladder cancer per 100,000 users does not seem alarming at first, 24 million people suffer from Type-2 diabetes and might consider taking Duetact or other pioglitazone medication. If millions of people take this medication, there could be thousands of extra cases of bladder cancer, a potentially deadly side effect.

Bladder Cancer typically begins in the lining of the bladder, in the “transitional cells” in the endothelium, which are designed to expand when filled with urine, and also protect the body from caustic effects of urine. These cells are highly susceptible to toxins, which is why bladder cancer is frequently caused by exposure to toxins in the workplace, cigarettes, and medications. Cancer begins when the transitional cells begin dividing out of control. The first symptoms are usually pain during urination and blood in the urine, but bladder cancer may go undetected until it is untreatable. If bladder cancer is diagnosed before it grows into tissues and organs surrounding the bladder, treatment and full recovery are still possible. Chemotherapy and surgical removal of cancerous cells are common treatments. Immunotherapy has also been developed, in which a physician injects a special vaccine into the bladder that causes the immune system to attack and destroy cancer cells. Like all cancers, bladder cancer is potentially fatal.

Duetact Banned in France and Germany

France and German medical authorities have suspended all sales of medications containing pioglitazone, including Duetact and Actos, following the results of a massive study that found a link between pioglitazone and bladder cancer. Researchers analyzed bladder cancer rates in 1.3 million people not taking pioglitazone, and compared this to bladder cancer rates in 155,000 pioglitazone-users. The people who used pioglitazone for at least two years had a 1.4-fold increased risk of bladder cancer. For all people who used pioglitazone, there was a 1.2-fold increased risk.

Duetact Side Effects

Heart Failure: Duetact can cause or worsen heart failure. Patients who have a history of heart failure should not use Duetact. A doctor should monitor new patients for signs of heart failure when beginning Duetact or increasing dosage.

Severe Duetact side effects include, but are not limited to:

  • Upper respiratory tract infection
  • Urinary tract infection
  • Bladder cancer
  • Heart attack
  • Bone fractures
  • Stroke
  • Liver problems
  • Fluid retention
  • Weight gain
  • Macular Edema
  • Congestive Heart failure
  • Low red blood cell count (anemia)
  • Low blood sugar (hypoglycemia)

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