In Recognition of National Bladder Cancer Month, Public Health Watchdog Warns that Long-Term Use of Actos May Increase the Risk of Developing Bladder Cancer

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The U.S. Food & Drug Administration (FDA) Warned in June 2011 that Taking Actos for More than One Year May Increase Bladder Cancer Risks by as Much as 40%. Since then, Studies Published in the British Medical Journal and the Canadian Medical Association Journal Have Confirmed that Patients who Take Actos Over a Long Period of Time are More Likely to Develop Bladder Cancer.

Public Health Watchdog, a media outlet created to inform the public about and protect them from defective drugs and medical devices, is recognizing Bladder Cancer Awareness Month by warning that long-term use of the type 2 diabetes drug, Actos, may increase the risk of developing bladder cancer. Actos has already been named in numerous lawsuit alleging long-term use of the drug caused patients to develop bladder cancer, most of which are pending in a federal multidistrict litigation underway in U.S. District Court, Western District of Louisiana (MDL No. 6:11-md-2299). According to a report from Bloomberg News, legal experts expect that Takeda Pharmaceuticals, the maker of Actos, could eventually be named in as many as 10,000 Actos bladder cancer lawsuits.

According to the American Bladder Cancer Society, bladder cancer is the 5th most common cancer overall. It is the 4th most common in men and the 8th most common in woman. Every year, 70,000 people will be diagnosed with new cases of bladder cancer, while over 14,000 deaths from bladder cancer will be reported. Common Symptoms of Bladder Cancer include:

  •     Pain during urination
  •     Frequent Urinary Tract Infections
  •     Painful Urination
  •     Frequent Urination
  •     Having to Urinate, but without results
  •     Pain in the lower back around the kidneys

Actos, approved in 1999 to treat patients with type 2 diabetes, is part of a class of drugs known as thiazolidinediones. Last summer, the U.S. Food and Drug Administration (FDA) announced that using Actos for more than a year increased the likelihood of bladder cancer by 40 percent compared to patients who have never been exposed to the drug. The FDA's announcement came just days after drug regulators in Germany and France suspended sales of Actos in those countries because of concerns that long-term use could raise bladder cancer risks.

Since the FDA issued its Actos bladder cancer warning, several studies have confirmed that use of the drug was associated with an increased likelihood of bladder cancer. On July 3rd, a meta-analysis published in the Canadian Medical Association Journal revealed findings that indicated a 22 percent increased risk of bladder cancer when using Actos. The study, which looked at the relationship between thiazolidinediones and bladder cancer, analyzed data from 10 different studies and 2,657,365 patients. A 15 percent increased risk of bladder cancer was observed with thiazolidinediones as a whole, and a 22 percent increase risk for Actos alone.

In May, a study published in the British Medical Journal found that taking Actos for two years doubles the likelihood that a patient will get bladder cancer. The study examined data on nearly 116,000 people treated for diabetes from 1988 to 2009 who were listed in the U.K.'s General Practice Research Database. The 376 people in the study who developed bladder cancer were compared to nearly 6,700 people who didn’t get the disease. Patients who had taken Actos had an 83 percent increase in the relative risk for bladder cancer. The risk increased for patients who took Actos longer, and who were exposed to the highest cumulative dose.

About Public Health Watchdog
Public Health Watchdog is a media outlet created to provide consumers with up-to-date information about defective drugs and medical devices that could endanger their health. For more information on other dangerous drugs and medical devices, please visit Public Health Watchdog today.

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Gary Falkowitz

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