Actos and Cancer

Actos (generic: pioglitzazone), a popular blood sugar lowering medication prescribed to people suffering from Type 2 diabetes, puts patients at an increased risk of cancer, the FDA says. When taken for at least one year and at high doses, Actos can lead to bladder cancer.

What You Can Do & How We Can Help

The Schmidt Firm, LLP is currently accepting Actos induced cancer cases in all 50 states. If you or somebody you know has been diagnosed with bladder cancer after using Actos, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Dangerous Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.

Actos and Cancer: An Overview

Along with lifestyle changes in diet and exercise, Actos (generic: pioglitazone) was FDA approved in July 1999 to control blood sugar in adults with Type 2 diabetes. Manufactured by Takeda Pharmaceuticals, the FDA estimates approximately 2.3 million patients filled a prescription for a pioglitazone-containing product from an outpatient retail pharmacy from January 2010 through October 2010.

Unfortunately, on June 15, 2011, the FDA released a Drug Safety Communication to inform patients who use Actos for more than one year — as well as patients with the highest cumulative dose — that they may be at an increased risk of bladder cancer.

Similar information has also been collected in France, causing France to suspend use of Actos all together and Germany to recommend no new prescriptions to new patients.

The FDA is recommending Actos and pioglitazone not be used in patients with active bladder cancer, and to be used with caution in patients with a prior history of bladder cancer.

Due to the severity of the side effects associated with Actos cancer, Actos cancer patients may want to contact an Actos lawyer or attorney with The Schmidt Firm, LLP to discuss the potential for a Actos cancer lawsuit.

Actos Cancer Side Effects

Research by the manufacturer and by the FDA has linked Actos to higher risks of bladder cancer. Signs and symptoms of bladder cancer may include:

Blood in the urine
Red coloring in the urine
Urinary urgency
Urinary frequency
Pain during urination
Urine leakage
Abdominal pain
Bone pain or tenderness
Fatigue
Weight loss

Studies on Actos and Cancer

Currently, Actos manufacturer Takeda is conducting a ten-year study on 193,099 patients with diabetes. After the five-year mark in the study, results suggested the risk of bladder cancer increased with a higher dose and longer duration of pioglitazone use.

As the FDA states:

“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 these 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 use of pioglitazone.”

Another study conducted by the French National Health Insurance Plan followed approximately 1.5 million patients with diabetes over a 4-year span.

The results of the study suggested that there was a significant increase in the risk of bladder cancer in patients exposed to pioglitazone, compared to patients exposed to other anti-diabetic drugs. Like the American study, these results intensified with stronger doses and exposure lengths (longer than one year). Additionally, male patients showed a significant risk increase, while females did not.

Bladder Cancer

The bladder is the organ that holds and releases urine.

In the normal population, bladder cancer is estimated to occur in 20 per 100,000 people in the United States per year. Normally, it starts in the cells lining the bladder and grows into tumors.

Bladder cancer may be dangerous because it can spread to nearby areas including the prostate, rectum, ureters, uterus, vagina, lymph nodes, bones, liver, lungs.

Certain risk factors may make you more likely to develop bladder cancer. These factors include:

Cigarette smoking
Chemical exposure
Chemotherapy
Radiation therapy
Bladder infection

Type 2 Diabetes

Type 2 Diabetes is a chronic disease characterized by high levels of sugar (also known as glucose) in the blood. It is the most common form of diabetes and is non-insulin dependent.

It is caused when the body incorrectly produces insulin, which is needed to move glucose into cells where it can be stored for later energy use. With Type 2 diabetes, the fat, liver and muscle cells resist the insulin. As a result, the sugar builds up in the blood, causing high blood sugar levels.

People who smoke, have inactive lifestyles, or have certain dietary patterns have an increased risk of developing Type 2 diabetes. The rates of Type 2 diabetes are growing dramatically in the United States and are often associated with weight gains and older age.

Symptoms of Type 2 diabetes may include increased thirst, increased urination, increased hunger, weight loss, fatigue, blurred vision, slow-healing sores, frequent infections, and areas of darkened skin.

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