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Diabetes Drug Actos Has Been Linked to Higher Risk of Bladder CancerMany people taking the diabetes medication, Actos, may not realize that studies have linked prolonged use of Actos with bladder cancer. An FDA study released in June examines a suspected link between the prolonged use of Actos and an increased risk of bladder cancer. From the FDA communication:

“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.”

The longer a patient takes Actos, and/or the higher the dosage, the greater the increased risk of cancer. In other words, patients with the highest “cumulative dose” have the highest increased risk. The FDA also acknowledges that, after a French study pointed to an increased risk of bladder cancer, Actos has been removed from the European market pending further investigation.

The results of the French National Health Insurance Plan investigation showed that after adjusting for age, sex, and use of other anti-diabetic medications, there was a statistically significant increase in the risk for bladder cancer in patients exposed to pioglitazone compared to patients exposed to other anti-diabetic agents. According to the French investigation, a cumulative dose of greater than 28,000 milligrams and an exposure of longer than one year led to a significant increase in bladder cancer, particularly in men.

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.

Read More:

[More on Dangerous Drugs]

(c) Copyright 2011 Brett A. Emison


  1. Gravatar for Dr Silman

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  2. Gravatar for Anonymous

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  3. Gravatar for Nick padron

    Typical lawyer ad trying to make money off some obscure finding. Remember the breast implant trial? After the lawyers made off with the money, studies showed no link between the implants and autoimmune disease. So, I am wary of any lawyer claims.

  4. Gravatar for Brett Emison


    Thanks for reading and offering a comment. However, it appears you have a couple of misconceptions. First, this post is not an advertisement. It's an opinion posts / blog commentary.

    Second, you refer to the result of the studies as "obscure findings". They are not. The European market does not remove drugs from the marketplace and the FDA does not revise drug warnings for "obscure findings".

  5. Gravatar for Nick padron

    The fact remains that you have an agenda. So, you will not represent all the facts. Again, remember the breast implant trial? Disproven claim, but after the lawyers got the money. Same thing happened with CP in newborns. You want the facts on Actos? I would only trust Dr Defronzo from San Antonio, Tx. He is the Guru on diabetes. I heard his talk on another drug in diabetes causing pancreatitis, but he presented all the data and showed how how trial data is manipulated, disproving the pancreatitis. So, I don't your Actos claim.

  6. Gravatar for Nick Padron

    "may be associated with bladder cancer.". That means the data is weak. Will need more studies to prove the connection. You would have to compare with a control group to see if there is a true increase in cancer with Actos. Diabetics have an increase risk of cancer anyway. By the way, diabetics have increased incidence of pancreatic cancer, but metformin decreases the incidence of pancreatic cancer. Metformin is a great drug for diabetes, but can cause metabolic acidosis in rare cases. But lawyers have tried to cash in on this. Would be tragic if metformin got taken off the market because of lawsuits involving this rare problem.

  7. Gravatar for Nick Padron

    Correction. Metformin rarely causes LACTIC acidosis. I don' t have anything against lawyers in general. Sometimes we need them to represent us, but every time some new claim comes up on a medication, even if it is a weak claim needing more studies, the lawyers pounce on it to make money without getting all the facts. At this time, a warning label is fine on the Actos, Patients and their doctors can decide whether to use Actos. Screen patients for cancers as recommended.

  8. Gravatar for Brett Emison


    Thanks again for your comments - you are obviously very passionate about this issue. However, it seems you and I have a different focus. Your focus is on lawyers who might be "cashing in" whereas my focus is on patient safety.

    I certainly did not conduct these studies. Lawyers didn't conduct these studies. Doctors and scientists conducted these studies. Doctors and scientists concluded the link between Actos and bladder cancers was substantial enough that doctors and scientists pulled Actos from the market in Europe.

    American doctors and scientists found the link between Actos and bladder cancer was substantial enough to add an enhanced warning of the link so patients could be more fully informed.

    I see many comments like yours suggesting lawyers are promoting these links. Lawyers are not. These links are there because of patient safety research by doctors and scientists.

    Now, certainly, you may disagree with the conclusions of these doctors and scientists. That is what free debate is about. In fact, such challenges are encouraged in science and in the law.

    Thanks for voicing your opinion.

Comments are closed.

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