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Actos Bladder Cancer FDA Warning

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The United States Food & Drug Administration (FDA) and the European Medicines Agency (EMA) have issued urgent safety alerts regarding the Type-2 Diabetes drug Actos® (pioglitazone). Analysis of clinical studies in the United States and Europe has revealed an increased risk of bladder cancer among patients prescribed Actos®.

FDA Warns: Actos® May Increase Risk of Bladder Cancer by 40%

On June 15, 2011, the FDA issued an urgent health warning to doctors patients that Actos® may increase the risk of bladder cancer by up to 40%. Long-term users of Actos® and those exposed to higher cumulative doses are among the groups at the greatest risk.

The FDA now requires that these recent findings and risks be included in the Warnings and Precautions section of the label for Actos® and other pioglitazone-containing medicines.

In the meantime, the FDA has chosen not to issue an Actos® recall and the drug remains available to consumers in the United States despite these alarming statistics. In June of 2011, Regulatory Agencies in France banned the use of Actos®, and doctors in Germany have been prohibited from prescribing the drug to new patients while the European Medical Association carries out further reviews.

Symptoms of Actos®-related bladder cancer may include:

  • Blood in urine, sometimes creating a change in urine color
  • Frequent urination
  • Painful urination
  • Urinary tract infection

Actos® and Bladder Cancer: History

Actos® originally received FDA clearance in 1999. At the FDA’s request, Takeda Pharmaceuticals agreed to undertake a 10-year epidemiological post-market study in 2002, investigating the questions raised about Actos® and bladder cancer.

An interim analysis of the data produced from the study showed an increased likelihood of bladder cancer developing in patients who took Actos® for the longest periods of time and at the highest cumulative doses. The FDA has informed the public that “…use of the diabetes medication ACTOS (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer.”

According to the FDA’s warning, “Compared to never being exposed to pioglitazone, a duration of pioglitazone therapy longer than 12 months was associated with a 40% increase in risk.”

No Actos® Recall in the United States Despite Health Risks

The FDA now requires that information about this increased risk be added to the Warnings and Precautions section of the label for Actos® and other pioglitazone-containing medicines. At this time, the Agency has stopped short of issuing an Actos® recall. The FDA “stresses that there is no definitive proof that Actos® causes bladder cancer and that patients who are currently taking it should continue to do so, unless otherwise advised by their healthcare provider.”

Read the FDA warning on Actos®.

France Bans Actos®

In June 2011, authorities in France decided to suspend the use of pioglitazone-containing medicines like Actos®, after a four-year study of 1.5 million diabetics found a 22% increased risk of bladder cancer among patients who had ever been exposed to Actos®. Patients who were prescribed the drug for more than 12 months had a 34% increased risk of developing bladder cancer, and those exposed to the highest cumulative doses had a 75% increase in risk.

The finding of the French study has prompted the European Medical Association to implement an immediate review of the safety of Actos® across the entire European Union. At the time of this writing, new restrictions on the use of Actos® have been introduced in Germany.

Actos® and Type-2 Diabetes

Actos® is an oral medication used to treat Type-2 diabetes in patients whose condition is not adequately controlled by diet and exercise alone.

More than 2.3 million people were prescribed Actos® in 2010.

Actos® belongs to a family of drugs known as Thiazolidinedione (TDZ), which are drugs used to lower blood sugar levels and increases the body’s sensitivity to insulin.

The active ingredient in Actos® (pioglitazone) is also used in combination with other Type-2 diabetes therapies in other medicines such as Actoplus met®, Actoplus met® XR and Duetact®.

Actos® became the world’s most popular Type-2 diabetes medicine in 2007, after medical studies linked Avandia®, a similar drug produced by GlaxoSmithKline, with a 40% increased risk of heart attack.

Approximately 20 Million Americans suffer from Type-2 Diabetes.

According to the National Cancer Institute, there were more than 70,00 cases of bladder cancer in the U.S. in 2010, resulting in 14,680 deaths.

Why Simpson Kepler Edwards?

National Leaders in Pharmaceutical Litigation
$1 Billion in successful verdicts and settlements

At Simpson Kepler Edwards, we have represented thousands of individuals who have been injured or who have suffered serious side effects after taking prescription medicines. For more than 15 years, our 100-strong team of lawyers, paralegals and nurses has been selected to lead high profile litigation involving the some of world’s largest pharmaceutical companies — and won.

With more than $1 Billion in successful verdicts and settlements, we believe that our knowledge, expertise and resources are unmatched. We are proud of the work we do; holding negligent pharmaceutical companies accountable, obtaining justice for our clients, keeping bad drugs off the market and, at the same time, saving lives. We are here to help.

Actos® Lawsuit: Claim Money Damages Now

If you or someone you know has developed bladder cancer after taking Actos®, you may be able to claim money damages and compensation for your current and future medical expenses.

We work on a percentage fee basis. It costs our clients nothing out-of-pocket to move forward with their claim, as our fees are based on any settlement recovered.

Contact us today with your Actos® Bladder Cancer questions. For a free consultation with one of our award-winning lawyers, call us at 307-527-7891 or email us. Don’t wait.


This website is sponsored by Burg Simpson Eldredge Hersh & Jardine, PC.
Burg Simpson Eldredge Hersh & Jardine, P.C. is a law firm serving the Rocky Mountain Region. The firm has offices in Denver, Colorado, Cody, Wyoming, Cincinnati, Ohio, and Phoenix, Arizona.
The firm is responsible for the content on the website. This information is not to be interpreted as providing legal services nor as proposing any form of legal advice.
This website is not affiliated in any way with Actos®.
Actos®, Actoplus met®, Actoplus met® XR and Duetact® are registered trademark of Takeda Pharmaceuticals. Avandia® is a registered trademark by GlaxoSmithKline.
You should always consult your doctor or healthcare provider before starting or stopping any medication.

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