The People's Perspective on Medicine

Actos Maker Settles Lawsuits Worth Billions but Keeps Selling Drug Linked to Cancer

Why is Actos, a drug that's banned in Europe, still on US shelves?

The drug Actos (pioglitazone) has been one of the most financially successful drugs in the history of diabetes treatment. It first went on sale in the U.S. in 1999. Since then it has been estimated that sales of Actos have exceeded $24 billion. That is a LOT of money.

But this week the manufacturer of Actos, Takeda Pharmaceutical, announced that it would settle thousands of lawsuits against this medication. Although the company isn’t admitting any liability in these lawsuits, it will pay out roughly $2.4 billion to people who took the drug or to their surviving families. The reason: Actos is linked to bladder cancer.

What makes this case unusual is that Actos remains on the market. In a new release we were told that, “Takeda’s decision to settle does not change the company’s continued commitment to Actos.” Say what? The company is prepared to pay billions to settle lawsuits with people who developed cancer but they are continuing to market Actos to people with diabetes. Does this make sense to you?

What Happened and Where Is the FDA?

On September 17, 2010 the FDA announced that it was:

“…reviewing data from an ongoing, ten-year epidemiological study designed to evaluate whether Actos (pioglitazone), is associated with an increased risk of bladder cancer. Findings from studies in animals and humans suggest this is a potential safety risk that needs further study.”

On June 15, 2011 (roughly 12 years after Actos started appearing on pharmacy shelves) the FDA announced that people who had taken Actos for more than a year might be at greater risk of bladder cancer. The agency warned that anyone with bladder cancer should avoid the drug, and it should be used “with caution” by those who had bladder cancer in the past.

On August 9, 2012, the Journal of the National Cancer Institute released a report suggesting that there was indeed a worrisome link to bladder cancer. Investigators reviewed records from more than 60,000 people with type 2 diabetes in the United Kingdom. Those who took Actos were two to three times more likely to be diagnosed with bladder cancer compared to those taking other antidiabetes drugs.

Actos Banned in France, Germany and India but Not in the U.S.

By 2011, regulators in France and Germany were convinced that Actos posed enough of a risk that they banned the drug. India followed with its own ban in 2013. But the U.S. Food and Drug Administration was content with a warning. It is written in classical FDA bureaucratic language:

“…There are insufficient data to determine whether pioglitazone is a tumor promoter for urinary bladder tumors. Consequently, ACTOS should not be used in patients with active bladder cancer and the benefits of glycemic control versus unknown risks for cancer recurrence with ACTOS should be considered in patients with a prior history of bladder cancer.”

There is also this in the official prescribing information:

Urinary Bladder Tumors

Tumors were observed in the urinary bladder of male rats in the two-year carcinogenicity study [see NONCLINICAL TOXICOLOGY (13.1)]. In two 3-year trials in which ACTOS was compared to placebo or glyburide, there were 16/3656 (0.44%) reports of bladder cancer in patients taking ACTOS compared to 5/3679 (0.14%) in patients not taking ACTOS. After excluding patients in whom exposure to study drug was less than one year at the time of diagnosis of bladder cancer, there were six (0.16%) cases on ACTOS and two (0.05%) cases on placebo. There are too few events of bladder cancer to establish causality.”

Have your eyes glazed over? It’s hardly any wonder that patients and prescribers might not have paid much attention to this information. Six vs. two cases of bladder cancer seems like a trivial risk. And the FDA seems almost reassuring in its conclusion that “There are too few events of bladder cancer to establish causality.”

The agency did not put a bladder cancer concern in the black box warning that already exists for Actos about the drug causing or exacerbating congestive heart failure. Bottom line: the FDA seems to have minimized the risk of bladder cancer. It’s hardly any wonder that doctors continued to prescribe the drug.

Billion Dollar Settlement

It must come as a tremendous shock to FDA officials to learn that there are roughly 9,000 bladder cancer claims against the manufacturer of Actos and that the company is willing to pay $2.4 billion to make them go away. This is one of the largest product-liability settlements in the history of the drug industry. Perhaps even more astonishing, Actos remains on the market with FDA approval.

So, here’s our question: Who is the FDA protecting? The American public or the drug company?

If regulators in France, Germany and India have all deduced that Actos is so dangerous that it should not be sold in their countries, why is the FDA continuing to allow its sale in the U.S., even after a billion dollar settlement?

We would value your thoughts on this controversial topic. Have you taken Actos? What was your experience? You can contribute a comment below in the “ADD MY THOUGHTS” section. And please vote on this article at the top of this page.

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    About the Author
    Joe Graedon is a pharmacologist who has dedicated his career to making drug information understandable to consumers. His best-selling book, The People’s Pharmacy, was published in 1976 and led to a syndicated newspaper column, syndicated public radio show and web site. In 2006, Long Island University awarded him an honorary doctorate as “one of the country's leading drug experts for the consumer.” .
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    I just lost my husband from heart failure. He was on actos for at least 17 years. He also had a lot of urinary issues which made us concerned. . we asked the doctor about actors. Was is it safe, could we change to something else. We were told not to worry. My husband became so weak,fatigued and stomach problems that he could barely do anything. We kept inquiring but got no where. I am angry I believe this drug attributed yo my husbands death. He was 62.they need to remove drug!


    Yeah, this is a dangerous drug gained weight 15lbs. I’m 4.8 1/2 I weighed between 115 117 gained 10 lbs for my little body that 10 lbs was to much. And I developed heart arrhythmia, ended in the ER. And I have to go a cardiologist. Can’t hardly move around without getting out of breath.

    Actos, even though the most preferred drug for diabetes. It is a well known fact that the drug has got severe side effects.

    I started taking Actos in early 2007 for my type II diabetes. At the time I was 43, a non-smoker and only about 15 pounds overweight. About a year and a half later I started urinating blood which led to tests, antibiotics, and eventually a diagnosis of bladder cancer. I underwent two surgeries to remove tumors, spent 2 weeks in the hospital due to complications from the surgeries and went through several months of liquid chemo treatments. At the time of diagnosis my urologist was unsure what caused the cancer. He said I was younger than most people diagnosed, and had no known risk factors.

    My cardiologist told me to stop Actos several years ago as I am Stage III renal failure and have had two open heart surgeries, history of kidney stones, lithotripsy for blockage of left ureter. She said Actos was notorious for causing swollen ankles, not only ankles but my legs also. I also had taken Avandia, and several other meds for Type II diabetes. After all these years from the time I was diagnosed, the doctors had told me to take one of the older statins, Gemfibrozil, that didn’t work out, then it was four others ones that gave me so many side effects.

    I would not take statins. My cardiologist said everyone over 60 should take statins, but everyone does not have a triglyceride problem. Since going off the statin, my Type II diabetes has been under control with my diet and I no longer need any pills or meds for the last almost 3 years. There has been reported literature stating that statins can cause Type II diabetes.

    When I look back over the years when I started the first of five different statins, that is about the time I was told I was a Type II diabetic. So don’t believe everything even the drs. tell you. Ask questions. Get answers. If your dr. doesn’t want to help you with info, get a different dr. I do not know how much damage taking those meds years ago to the present has done to me, but I have had rheumatic fever in my adult life three times, the doctors did not want to believe it was possible until finally he said I must have a high sensitivity to the strep germ. And at least two of our five children are also. So we watch sore throats very closely. Rheumatic fever can affect your kidneys, heart and other organs. And also antibiotics cause side effects, I am down to about only two I can now take except for going to IV if something is needed. I don’t drink or smoke, so it is not from not trying to take care of my health. If someone does not understand what the dr. tells them have a friend or relative go to the appt. with the person so they can have notes taken or things explained to them until they understand what they are dealing with.

    Remember, doctors practice! They don’t have all the answers and they should be open minded enough to help you with your problem and if they aren’t time to go somewhere else.

    we all know that the fda is a complete joke, in the pockets of the drug companies.

    Am I not correct that thalidomide was available in Europe….and a Doctor refused to let it in to the U. S.? That’s the reversal of the post saying that it was not allowed in Europe but was allowed here in the U. S.

    Serious side effects are routinely ignored. I’ve learned to refuse drugs dangerous to me, and guess what? They always have a safer substitute that is not marketed so aggressively.

    I’m glad I took myself off of this. I was prescribed this in Jan., and two weeks later I had the worse UTI that I have ever experienced. It may have been a coincidence, but I still feel the drug was partially responsible. Even-though I am concerned about the bladder cancer (my father just passed away from it), I’m more concerned about the congested heart failure since I have had recent quadruple bypass surgery. Neither my physician or pharmacist (and there was no warning pertaining to this) told me.

    Took Actos for 4 years. Developed cancer in right kidney. Related? Don’t know but I sure discontinued Actos after they surgically removed my kidney. I wonder if any other cancers than blatter have been associated with Avtos or it’s cousin Avandia, which I also took.

    Money, money, money is the reason the FDA doesn’t protect the people when the drug companies don’t want the people protected. There are as many ways of getting money and influence to the decision makers of the FDA as there are of getting it to the politicians. No wonder people have lost faith in US intuitions and government.

    Please keep up your good work in reporting on such happenings. I have been a subscriber for several years and following the advice of you and other subscribers on many things. I’m happy to report good results on most that I’ve tried.


    I have taken Actos for 28 years without any known problems to date. I am 74 years old and I’m a type 2 Diabetic.
    I tried insulin for 2 years but like taking oral Diabetes meds instead… I take 3 other Diabetes meds as well.

    Actos was your buddy Steve Nissen’s baby during the “clotting studies” – what does he think? I used Actos some, but it was more expensive than Avandia – I never saw bladder cancer in a TZD patient although bladder cancer numbers are increasing with or without TZD’s. I never saw clotting but all my patients with diabetes were on some kind of platelet agent or anticoagulant as part of a plaque prevention program. ‘Heart failure” happens with any effective diabetes drug which stops osmotic diuresis in uncontrolled patients – ACE’s and ARB’s prevented fluid accumulation in most people if treated early and also lower inflammation which is helpful.

    As long as Congress continues to permit FDA to obtain any of their funding from industries they are supposed to regulate, we can expect to see more instances like this. The blatant conflicts of interest make me sick.

    If something is banned in Europe, that’s enough to cross it off MY list.

    And the “protection” of the FDA? Oh, puh-LEEZE! If you believe in that, I have some very nice swampland for sale, ready for development.

    I took this medicine for about a year and did not like the way I felt on it. I also developed persistent swollen ankles. I mentioned the way I felt to a kidney specialist who was treating me for a temporary problem at the time, and who happens to be Indian, and he immediately took me off the drug and stated that he didn’t like this particular medicine.

    I took Actos for ten years, until ten years ago. I asked three doctors and a hospital medical staff doctor to let me stop that drug. I had gained a huge amount of weight and my legs had swelled. They just said that’s what happens to diabetics. I would lose my legs. I wasn’t buying it. I knew it was the drug Actos causing my problems. My legs had huge blisters on them that seeped. Even gangrene set in. At that point, a friend recommended a naturopathic doctor. He investigated the drug, called me and said it’s a horrible drug. He took me off of it, gave me an antibiotic, and three weeks later my legs were normal and my weight had started coming down. I lost 140 pounds. The FDA is in the hands of the drug companies. They don’t care. Listen to your body. Sometimes you do know what’s best. I still go to that ND and still have my legs. Actos should be removed the market. The FDA doesn’t have the guts to do it.

    yessiree, trust yer doctor?
    my ex boss went for his Actos refill, the pharmacist refused, so a call to his doc was made… said good doc demanded the prescription be filled… yup, boss has bladder cancer.

    You can’t blame the pHarma & FDA sharks…it’s Bu$$iness. Until we, the Sheeple, wake up, the genocide will continue.

    This is not the first time and I expect that it will not be the last, that European countries have been proactive in caring for the health of their citizens. If people remember Thalidomide, in the 50’s and 60’s was promoted here as the wonder birth control drug. European nations, where the drug was developed were the first to recognize its danger and ban it. It took the U.S. much longer to do so. I believe this is because the European nations are small enough that the Governments react more quickly and have more respected medical researchers. The countries also do not have the massive concentrations of production facilities in one country which affect the economy as much as in the U.S. This concentration gives the corporations greater control over government policies.

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