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Actos, the popular diabetes drug manufactured by Japanese company Takeda Pharmaceuticals, has a troubled history and is the subject of many lawsuits. There are so many lawsuits that cases are being consolidated into MDLs (multi-district litigation) in state courts in Illinois and California, with an MDL pending in Louisiana. The first bellwether trial is set for November 2014.

Actos is produced by Takeda and marketed in the U.S. by pharmaceutical company Eli Lily. It was originally approved by the FDA in 1999, and since 2007 has been the most prescribed drug in the country for treating Type 2 diabetes. Actos is marketed under several different names, including ACTOS, ACTOplus met, ACTOplus met XR, and duetact. In 2010 there were some 2.3 million prescriptions written for Actos making it the 10th most prescribed drug in the United States, accounting for sales of $4.8 billion.

Learn More: Actos Litigation: A comprehensive look at the litigation landscape for Takeda's diabetes drug, as studies link its long-term use in some to bladder cancer, as published in Forum magazine

Despite Actos' popularity, Canadian researchers found that Actos doubles the risk of bladder cancer. Their research and report can be found in the British Medical Journal.

In June 2011, France, and then Germany, banned Actos, instructing doctors to stop prescribing the diabetes medication to future patients after a French study confirmed that Actos caused an increased risk of bladder cancer.

While the United States has not yet banned use of Actos, in June, 2011, the U.S. FDA issued a communication warning of a link between prolonged (more than one year) Actos use and bladder cancer. The FDA’s communication read, in part:

“The U.S. Food and Drug Administration (FDA) is informing 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. Information about this risk will be added to the Warnings and Precautions section of the label for pioglitazone-containing medicines. The patient Medication Guide for these medicines will also be revised to include information on the risk of bladder cancer.”

It turns out that Japanese drug giant, Takeda Pharmaceuticals, knew for years before even releasing Actos of its likelihood to increase the risk of bladder cancer in patients. Prior to releasing Actos in 1999, Takeda had a 2-year study that showed an increased risk of bladder cancer in rats that had been given Actos. These studies were not provided to the FDA or other health regulators.

Many people taking Actos may not realize that studies have linked prolonged use of Actos with bladder cancer.

The total (cumulative) dose exposure to Actos is an important factor because the more Actos a patient has taken, the higher the risk of bladder cancer. In other words, the longer a patient takes Actos, and/or the higher the dosage, the greater the increased risk of cancer. Patients with the highest “cumulative dose” have the highest increased risk.

The FDA’s recommendation for patients taking Actos:

  • There may be an increased chance of having bladder cancer when you take pioglitazone.
  • You should not take pioglitazone if you are receiving treatment for bladder cancer.
  • Tell your doctor right away if you have any of the following symptoms of bladder cancer: blood or red color in urine; urgent need to urinate or pain while urinating; pain in back or lower abdomen.
  • Read the Medication Guide you get along with your pioglitazone medicine. It explains the risks associated with the use of pioglitazone.
  • Talk to your healthcare professional if you have questions or concerns about pioglitazone medicines.
  • Report side effects from the use of pioglitazone medicines to the FDA MedWatch program, using the information in the "Contact Us" box at the bottom of the page.

You should not stop taking this, or any, drug without consulting your health care provider. If you are currently taking Actos, you should contact your physician to evaluate and determine your treatment options.

[More on Actos]

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© Copyright 2012 Brett A. Emison

Follow @BrettEmison on Twitter.

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