Actos Increases Bladder Cancer Risk by 40%, FDA Says
Jury Hits Actos With $10.5 Billion Verdict
APRIL 7, 2014: A federal jury found that Takeda Pharmaceuticals and Eli Lilly & Co. marketed Actos despite knowing about the risk of cancer it carries. They ordered the companies to pay a combined $10.475 billion in punitive and compensatory damages to an Actos victim, making it among the largest civil trial verdicts in history.
In 2011, the Food and Drug Administration issued an alert to warn that:
- People who take Actos for 1 year are 40% more likely to be diagnosed with bladder cancer.
- Another study also tied Actos to an increased bladder cancer risk.
The safety label on Actos was changed to reflect the link to cancer in August 2011. But, by then, Actos had already been on the market for over a decade, and millions of prescriptions had been filled for diabetics. Their health and safety were put at risk without their knowledge. If taking Actos has caused bladder cancer in you or a loved one, you should contact our attorney today. We want to tell you how we can fight to get you the justice and compensation you deserve for your hardship.
15,000 Bladder Cancer Deaths Every Year
More than 72,000 people will be diagnosed with bladder cancer in 2013, and it will claim the lives of roughly 15,200 Americans this year, according to the National Cancer Institute. The cancer is far more common in men than women. Symptoms include:
- Abdominal pain
- Blood in urine
- Painful and/or frequent urination
- Urine leakage
- Weight loss
Early detection is vital to successfully fighting bladder cancer.
Cancer Risk Well-Studied
Actos sales have been halted in France and Germany due to the risk of bladder cancer. Canadian officials have also expressed concern about Actos. But it remains on the U.S. market even though:
- Actos users have a 40% increased risk of bladder cancer after a year of taking the drug, according to the FDA.
- A February 2014 study in the British Journal of Clinical Pharmacology found a “clinically significant” increased occurrence of bladder cancer in patients taking Actos.
- Diabetics who take Actos increase their risk of bladder cancer by 22% over those taking other diabetes medications, according to a 2011 French study.
- A 2012 study in the Canadian Medical Association Journal also found that Actos carried a 22% increased risk of bladder cancer after examining records of more than 2.6 million people.
- A 2014 study in the British Journal of Clinical Pharmacology found a “clinically significant” increased occurrence of bladder cancer in patients taking Actos. Researchers wrote that the drug should be prescribed for shorter intervals to protect patients.
The watchdog publication Consumer Reports has urged Americans to avoid Actos due to its dangers. Those who have already been harmed are turning to legal action to seek justice.
Actos and Bladder Cancer
Studies have revealed that the Type 2 diabetes medication Actos (pioglitazone) may be linked to an increase in the risk for developing bladder cancer. During a 5-year interim review of a 10-year study by Kaiser Permanente Northern California, researchers found that patients who took Actos for more than 12 months had a 40 percent higher risk for developing bladder cancer.
The 12-month study is still underway; however, the results from the interim review should have raised more of a red flag in the U.S. Instead of banning the drug from the market after learning the results from the study, the U.S. Food and Drug Administration (FDA) required that new warnings about the risk of bladder cancer be added to the drug's labeling.
Actos Banned in France and Germany for Bladder Cancer
Around the same time, a three-year international study was conducted by the French Medicines Agency. The study, which took place from 2006 to 2009 examined 1.5 million patients. Results showed that patients taking pioglitazone clearly had a greater risk for bladder cancer than those not taking the drug.
In response to the results, use of Actos in France was suspended in June 2011. Germany was quick to follow suit and banned use of Actos in any new patients. Actos remains available for use in the U.S. despite evidence of a risk of bladder cancer.
About Bladder Cancer
Bladder cancer is one of the most common forms of cancer in the U.S. According to the National Cancer Institute, it has been estimated that 72,570 new patients will be diagnosed with bladder cancer in 2013; of these, it is estimated that 15, 210 cases will result in death.
Risk factors for bladder cancer include smoking, certain chemicals found in the workplace, arsenic, certain medications and certain cancer treatments. Individuals with a family history of bladder cancer usually have a higher risk of getting it as well.
Symptoms of Bladder Cancer
The most common symptoms of bladder cancer include:
- Blood in the urine
- Feeling an urgent need to empty the bladder
- Frequent urination
- Pain during urination
Individuals taking Actos should seek medical attention immediately if they experience these symptoms.
Bladder Cancer Treatment
The type of treatment used will depend on where the tumor is located in the bladder, whether the tumor has spread to other parts of the body, whether the tumor has invaded the muscle layer or tissues outside of the bladder, the grade of the tumor and the person's age.
If you are diagnosed with bladder cancer, your doctor will likely refer you to a specialist who will explain your treatment options in detail. Treatment options include:
- Biological therapy
- Radiation therapy
Before you start treatment, talk to your doctor about the possible side effects of treatment and how it will affect your everyday life. You and your health team can decide what option is best for you.
Get Help by Filing a Bladder Cancer Lawsuit
If you are diagnosed with bladder cancer and have been using Actos as a treatment for diabetes, you should contact an Actos cancer lawyer as soon as possible to discuss your chances of winning a bladder cancer lawsuit. A cancer lawsuit can help you recover the much needed compensation to pay for your expensive medical bills and to help you meet your financial obligations while you are focusing on your health.
Our attorneys are experienced in Actos litigation and can help ensure that you recover the highest settlement or award so you can receive the best medical attention possible. We will also help you get the compensation you need to meet your other financial responsibilities while you are sick, including your mortgage and other bills and will make sure you get the compensation you need to continue to support your family.
Contact Us To Get Help
Drug manufacturers are responsible for selling safe products and warning users of all risks. When their products harm innocent people, they need to be held accountable. Bladder cancer is no minor side effect. It’s a serious disease that kills thousands of Americans every year. If you or a loved one has been diagnosed with bladder cancer after taking Actos, contact us for a free, no-obligation consultation. Our attorneys want to protect your rights and seek compensation for you and your family. Get the justice you deserve. Time to file a claim is limited, so don’t delay.