Takeda Seeks Approval of New Actos Combination Drug, Even as it Faces Actos Bladder Cancer Lawsuits

The pharmaceutical manufacturer, Takeda, is set to receive a decision from the Food and Drug Administration on January 25, 2011 regarding a new drug for diabetes therapy which combines alogliptin and Actos into a single tablet. In July 2011, Takeda re-filed an application to have the drug approved by the FDA and eventually have the drug made available to the public. The new data submitted to the FDA includes information about a cardiovascular outcomes trial. The new drug would be the first in the United States to have both a thiazolidinedione and a DPP-4 inhibitor in a single pill. Currently, Aloglitin is sold in other countries and has been approved by some regulators overseas.

However, the possible increased risk of bladder cancer from taking Actos for a year or more cannot be overlooked. In August 2011, the Food and Drug Administration approved updated labeling for Actos, a type 2 diabetes drug intended to regulate insulin and blood sugar levels in patients. The updated labeling indicates that the use of pioglitazone (Actos) for more than one year may be associated with an increased risk of bladder cancer. Lawsuits from patients across the United States have been filed against Takeda Pharmaceuticals, alleging that their use of Actos caused them to develop bladder cancer.
As a number of lawsuits are pending and more are being filed, Takeda is continuing to press ahead and seek approval of another drug containing Pioglitazone. In 2010, more than 2 million patients were taking Actos. In one study done on the drug that evaluated 193,000 patients who were taking Actos for an average of 2 years, it was determined that their risk of bladder cancer increased 40% compared to if they had never been exposed to the drug. Studies concerning the bladder cancer risk are still ongoing

The law firm of Rudolph F.X. Migliore, P.C. is currently accepting cases involving Actos and bladder cancer. If you or a loved one has developed bladder cancer after taking Actos, you may be entitled to compensation for the harm Actos has caused.

With over three decades of experience, the Law Firm of Rudolph F.X. Migliore, P.C. is well positioned to help those who have suffered because of the dangerous diabetes drug Actos. The firm works with nationally-recognized co-counsel to reach major verdicts while providing individual, personalized attention. Call us for a free consultation at 631-543-3663 or visit our website: actos-bladdercancer.com for more information.

Diabetes Drug Actos- Frequently Asked Questions

Diabetes Drug Actos Questions

What is Actos?

Actos is a prescription drug that is primarily prescribed to patients who have type- 2 diabetes. It is used to regulate the amount of insulin in the body. Usually, Actos is prescribed to lower the amount of glucose present in the blood.

What forms of Actos are there?

There are several forms of Actos prescribed, including Actos, Actosplus met, and Actosplus met xr.

What are some of the problems with Actos?

Actos has a black box warning, the FDA’s highest warning for a drug that is still allowed on the market, for its increased risk of heart attack. However, new studies are linking it to an increased risk of developing Bladder Cancer.

Has Actos been pulled from the market?

Actos is still available for purchase in the United States but in France and Germany it has been taken off the market. A French study looked at over one million patients and concluded that patients taking Actos were put at a 22% higher risk for developing bladder cancer over those who had not taken the drug. Another study that was reviewed by the FDA, indicated up to a 40% increased risk of developing bladder cancer as a result of taking Actos.

Who is most at risk for developing bladder cancer while taking Actos?

The chance of developing bladder cancer with Actos use increases the longer a patient has been taking it. Those who have the higher cumulative doses are more at risk. The more Actos that a person has ingested, the greater the risk of developing bladder cancer.

What steps has the FDA taken?

In September 2010, the Food and Drug Administration announced that they were reviewing preliminary safety information on Actos. The FDA has continued to monitor studies performed by the manufacturer of Actos and ones performed in Europe. Then, in June 2011, the FDA issued an “urgent health warning” relating to the bladder cancer risk of Actos. The FDA approved new labeling on Actos to include the Bladder Cancer risk. They will continue to monitor studies and new information. Actos remains on the market in the U.S. although it has already been pulled in some European countries.

What legal options do I have if I developed Bladder Cancer after taking Actos?

After you have begun treatment for bladder cancer, it is important to contact an Actos lawyer to protect your legal rights. An Actos lawyer can evaluate your case against the manufacturers of Actos and determine the best way to proceed forward in the legal system. By contacting a lawyer, your rights will be protected. If a firm accepts your case, they will review your medical records and begin a lawsuit on your behalf.

Actos-Bladder Cancer cases are becoming prevalent, New York Attorney reports

The diabetes drug Actos may be linked to Bladder Cancer. While the FDA’s highest warning appears on Actos for its heart attack risk, no such warning appears for Bladder Cancer. Research has shown that taking Actos for more than 1 year may increase a patient’s chance for developing Bladder Cancer by up to 40%. With over 2 million people prescribed Actos, the law firm of Rudolph F.X. Migliore, P.C. has seen a number of inquiries related to Actos litigation. Actos is used to regulate the level of glucose in the bloodstream in patients with type 2 diabetes.

Diabetes is a prevalent disease in the United States and Actos use has steadily increased, especially after a similar prescription drug, Avandia, was pulled off the market because it was linked to an increased risk for heart attacks. The relationship of Actos to bladder cancer has only recently been examined and consequences are being monitored by the FDA. In August 2011, the FDA approved updated labeling for Actos stating that taking the drug “for more than one year may be associated with an increased risk of bladder cancer”. The FDA has been conducting an ongoing review of the connection between Actos (pioglitazone) and Bladder Cancer based on studies conducted over the last 10 years by the drugs’ manufacturers, as well as studies done in Europe which suggested an increased risk from using Actos (pioglitazone) and developing Bladder Cancer.

As this potential link has become more prevalent, the law firm of Rudolph F.X. Migliore, P.C. has been hearing from patients that have been taking Actos for an extended period of time and have developed bladder cancer. The firm initially started investigating case related to Actos and Bladder Cancer from throughout the United States in July 2011 and is continuing to accept cases.

With over three decades of experience, the law firm of Rudolph F.X. Migliore, P.C. is well positioned to help victims of Actos related Bladder Cancer. The firm works with nationally recognized co-council to provide powerful representation for their clients, while providing them with personalized service. If you or a loved one has been harmed while taking Actos, call Rudolph F.X. Migliore, P.C. at 631-543-3663 or visit Migliorelaw.com .

Diabetes Drug Actos and Bladder Cancer

Actos is a prescription medication used to treat type 2 diabetes. In recent years it has become more popular because its competitor, Avandia, was taken off the market due to an increased risk of heart failure. Now, serious questions are being raised about the side effects of Actos as well.

Several studies have found that Actos also causes an increased risk of both bone fractures and heart attacks. What is also very concerning is that the Journal of American Medicine and the FDA are both warning that taking Actos for more than one year can carry a much higher risk of developing Bladder Cancer. This has prompted Germany and France to pull the drug from the market while further testing is performed. On June 15, 2011, the FDA issued an “urgent health warning” after a review of studies showing up to a 40% increased risk of developing Bladder Cancer after a patient had been on Actos for more than a year. The FDA has not yet taken the additional step of pulling the product from the market and it is still available for purchase. However, the medication is subject to further review and is being closely monitored by the FDA.

Actos, especially when prescribed long term, has the potential to do much greater harm than good. Bladder Cancer is a debilitating, life-threatening disease, yet Actos is still readily available. Potential lawsuits are being investigated across the country to help victims of Actos. It is important that the manufactures of these dangerous drugs are held liable and victims are compensated for their incredible pain and suffering.

The Law firm of Rudolph F.X. Migliore, P.C. is now accepting Actos Bladder Cancer cases. With over three decades of experience, the firm is well positioned to help victims of Actos. The firm works with nationally-recognized co-council to reach major verdicts while providing local, personalized service. If you or a loved one has taken Actos and has developed Bladder Cancer, or if you need further information, contact our office at 631-543-3663 or visit our website at migliorelaw.com .

Bladder Cancer Information

Bladder cancer is a form of cancer that usually begins when cells that line the bladder develop tumorous growths. It is a common cancer, although there is little awareness of it, with close to 70,000 diagnoses and 15,000 deaths expected from it this year alone (1). Men are much more likely to develop the disease than women are. The cancerous cells begin to grow rapidly and spread to other parts of the bladder, forming a region of abnormal tumorous cells. These abnormal cells do not expand normally but instead expand rapidly and at much greater speed than normal cells. These tumors can overtake healthy cells because they block oxygen and inhibit their ability to receive the nutrients and material they need.
Bladder cancer cells can undergo Metastatis, meaning that the cancer spreads to other parts of the body than where it originated. In this case, bladder cancer often transfers from the bladder to the lymph nodes and kidneys before spreading to the blood stream where other vital organs, like the heart and lungs, are likely to be affected.

Like with most cancers, bladder cancer is diagnosed as being in one of five main stages. Stage 0 (pre-stage) is when the cancer is in the center of the bladder but has not yet reached the connective tissue or the muscle wall. Spreading has not yet begun. Stage 1 indicates that the cancer has reached the connective tissue but has not penetrated the muscle of the bladder wall. In Stage 2, the cancer has grown into the muscle layer of the bladder wall and the fatty tissue around the bladder. Stage 3 is characterized by cancer that has completely penetrated the fatty tissue of the bladder and possibly the surrounding organs, but has not yet made contact with the lymph nodes or areas that are farther away. In Stage 4, the cancer has either gone through the pelvic or abdominal wall, spread to the lymph nodes or reached a distant site such as the bones, liver or lungs.

Treatment options vary by stage. Surgery may be done to remove the cancer or tumor. This sometimes involves directly removing the cancer or removing the entire or part of the bladder and any affected lymph nodes and organs. Radiation is another common treatment method that involves using high energy x-rays to kill or contain the cancer cells. Chemotherapy uses powerful drugs to combat cancer, sometimes given throughout the body or directly applied to the bladder. Other approaches include strengthening the body’s natural immune system to help it fight the cancer off itself. A number of clinical trials are also being performed to develop new methods to combat this vicious disease.

Bladder Cancer Risk Factors

There is no one complete determination of what causes bladder cancer or what increases ones risk factors. It is, however, well established that cigarette smoking makes a person more likely to contract the disease. Smoking is a major risk factor for bladder cancer. Workplace exposure is another risk factor that includes exposure to dangerous chemicals. Some chemicals have been linked to bladder cancer. Different ethnicities are also more pre-disposed to developing bladder cancer and age can be a major factor, with 90% of bladder cancer patients over the age of 55. Men are also at a much higher risk for bladder cancer than women.

Some new reports have indicated that the diabetes drug ACTOS may also increase the chances of developing bladder cancer, with some sample sizing showing as much as a 40% increase. The drug has already been pulled from the market in several European countries. The Law firm of Rudolph F.X. Migliore, P.C. is investigating ACTOS cases in the United States. For more information see our ACTOS page or Contact us at 631-543-3663.

If you are taking ACTOS, talk to your doctor about proper dosing and the potential dangers. If you or a loved one has been harmed due to ACTOS do not hesitate to contact our firm today at 631-543-3663 for a free consultation. You may be entitled to compensation. With over three decades of experience, the law firm of Rudolph F.X. Migliore, P.C. is well positioned to help those harmed by Actos. The firm works with nationally recognized co-counsel to reach major verdicts.

(1) http://www.cancer.gov/cancertopics/types/bladder

The Dangers of the Diabetes Drug Actos

New studies are finding that the diabetes drug Actos increases the risk of bladder cancer, specifically in those who have used it for more than a year. A similar drug, Avandia, has already been removed from the market after being linked to an increased risk of heart attacks. In fact, Actos and Avandia are the only two drugs in the class called thiazolidinediones, and work in very similar ways. Actos has already been removed from the market in Germany and France for these same concerns.

Actos is a drug used for patients who have type 2 diabetes. It is used to control the level of glucose in the blood stream when used with a healthy diet and exercise. It now carries a warning label for an increased cancer risk, but it remains on the market with the full support of the manufacturer. In 2010, more than 2 million patients were taking Actos. In one study done on the drug, out of 193,000 patients who were taking Actos for an average of 2 years, their risk of bladder cancer increased 40% compared to if they had never been exposed to the drug.

One of the reasons Actos is yet to be pulled from the U.S. market is because the drug companies insist they have nothing to replace it with. However, that does not justify the significant risk this drug puts its users at. Bladder cancer is a horrific disease that often results in a long and painful journey. It does not have a very high survival rate, and it has a very high recurrence rate among survivors. For every 50,000 people that develop bladder cancer, 12,000 will ultimately die from it. Attorney Rudolph Migliore states “with the decrease in Avandia usage, there has been a rise in Actos but ultimately its effects can be just as harmful.”

It is not advisable to stop taking Actos without talking to your doctor, but if you are on it, proceed with extreme caution in regards to dosage and any warning signs of bladder cancer. If you or a loved one developed bladder cancer after taking Actos, do not hesitate to call our law firm today for a free consultation at 631-543-3663. You may be entitled to compensation for the harm Actos has caused.

With over three decades of experience, the Migliore law firm is well positioned to help those who have suffered because of the dangerous diabetes drug Actos. The firm works with nationally-recognized co-council to reach major verdicts while providing individual, personalized attention. Call for a free consultation at 631-543-3663 or visit migliorelaw.com for more information.