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The FDA warns of increased bladder cancer risk associated with the use of the diabetes drug Actos (pioglitazone).

This warning comes after a review of data from a five-year interim analysis of an ongoing study of Actos by the manufacturer, Takeda Pharmaceutical Co.

The results show that although there was no increased risk of bladder cancer among Actos users overall, there was an increased risk of bladder cancer amongst those who had used the drug the longest. There was also a greater risk of bladder cancer among Actos users who had been exposed to the highest cumulative dose of the drug.

Prior to the FDA warning – several European Markets, France and Germany, suspended the use of Actos, citing concerns over an increased risk of patients developing bladder cancer.

Takeda’s Type2 Diabetes drug, Actos, grew in popularity after use of Avandia; GlaxoSmith Kline’s controversial drug was severely restricted in the US because of concerns of an increased risk of heart attack and heart failure last fall. Takeda had profits from sales of Actos in the U.S of over $3 billion in 2009 and just under $3 billion in 2010.

Given the publicity over the health risks of the two most popular anti-diabetic drugs, it leaves diabetics in a difficult position. Is there a drug that is worth the risk?

If you are a diabetic, it is imperative that the focus remain on your health – although the bad news can seem overwhelming, we believe that it is important to provide you with full information so that you can make informed health decisions. Unfortunately, that information has historically not been available with respect to Avandia and Actos. At this point, it is advisable that you discuss these risks with your physician to determine the best treatment option for you.

If you already have bladder cancer, and you suspect it may be the result of taking Actos, it may also be time to talk to an attorney as well.


  1. Gravatar for Bill MacQuoid
    Bill MacQuoid

    I am a DM2 from Agent Orange exposure in 1969 and have been diagnosed for 10 years now. I take 1 tablet of 30MG Pioglitazone a day along with Medformin 1000 MG twice a day and 40 units of insulin once in the evening. If Pioglitazone is harmful, why does the VA still authorize its use?

  2. Gravatar for fabio marchese
    fabio marchese

    I ask you why pioglitazone (ACTOS) is also present in Italy, even it's suspended in France and Germany? Is there a business?

  3. Gravatar for Eric Terry
    Eric Terry

    The European Medicines Agency (EMA)as a whole is still evaluating the pioglitazone situation. France and Germany have made individual decisions that the risks of the drugs outweigh the benefits and have pulled the drug. Other countries have not yet taken that step. Yet.

  4. Gravatar for Eric Terry
    Eric Terry

    Bill -

    First of all, thank you for your service and I am sorry to hear that as a result of your service, you now have type 2 diabetes.

    With regards to your question, the VA can still prescribe Pioglitazone because the FDA has not pulled the drug from the market. The FDA sent out a warning about the increased risk of bladder cancer but didn't go as far as France and Germany in pulling the drug.

    For now, the decision of whether to take Actos is one that needs to be made with the assistance of your VA doctor after weighing the risks of bladder cancer.

    I commend you for being proactive with your health.

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