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September 17th, 2010
05:00 PM ET

FDA reviews diabetes drug Actos

Another diabetes drug is under the Food and Drug Administration's microscope amid safety concerns. On Friday, the agency announced preliminary five-year data shows Actos can increase the risk of bladder cancer in patients using the drug long-term.

Pioglitazone, marketed as Actos, is one of two drugs used to control blood sugar in diabetics.  The data are from a 10-year study by the manufacturer Takeda Pharmaceuticals of San Diego.  The early results did not show an overall link between use and the risk of bladder cancer, but taking the drug for a long time or in high doses may increase the risk, according to the study.

In July a FDA advisory committee looked at whether to pull GlaxoSmithKline's diabetes drug  Avandia off the market because of concerns it increased the risk of heart attack and stroke. 

The committee was split on whether to pull the drug– 12 of the 33 members voted to withdraw Avandia from the market, while 20 voted to allow it to remain with enhanced restrictions and rigorous black box warning labels.  The agency says it  has no data linking Avandia to bladder cancer.  Actos and Avandia are in the same class of drugs.

A FDA statement said the review is ongoing, and that it "has not concluded that Actos increases the risk of bladder cancer."   Patients with any concerns about Actos should not stop taking the drug but talk to their doctor, the FDA advised.


soundoff (29 Responses)
  1. Janet

    This has been known by the FDA for many years. They purposely allow the drug makers to endanger the health of the people.

    Actos took in 4 BILLION$$$ last year and the FDA receives kickbacks from the drug companies. A filmmaker has been reversing diabetes in now 10 countries WITHOUT medication and the drug companies do not promote the story
    just google SPIRIT HAPPY DIET

    September 17, 2010 at 18:27 | Report abuse | Reply
  2. Not a Harvard Grad

    If there are so-called problems with Avandia and Actos is in the same class what do you think.......

    September 18, 2010 at 15:02 | Report abuse | Reply
  3. More Cheeseburgers

    Cardiovascular problems were actually linked to this class of medications from day 1 ...does the risk outweigh the benefit?
    Empower us LIzard Crowen..........

    September 18, 2010 at 15:04 | Report abuse | Reply
  4. Lizard Crowin Senior Top Ceo Big Dog Medical Sensational Panic Writer

    Lizard Crowin Senior Top Ceo Big Dog Medical Sensational Panic Writer is on the case and blogging about it!

    September 18, 2010 at 15:08 | Report abuse | Reply
  5. Lizard Crowin Senior Top Ceo Big Dog Medical Sensational Panic Writer

    CNN is copying Faux News with the sky is falling and misinformation...................

    September 18, 2010 at 15:09 | Report abuse | Reply
  6. Lizard Crowin Senior Top Ceo Big Dog Medical Sensational Panic Writer

    cue the music...........dum dum dum...

    September 18, 2010 at 15:10 | Report abuse | Reply
  7. OKALH

    From what I continue to read about their various approaches I have less and less faith in the FDA! Indeed, much less!

    September 19, 2010 at 03:25 | Report abuse | Reply
  8. Malcom Alden Crowe Cohn

    We need FDHA approval now!

    September 19, 2010 at 17:16 | Report abuse | Reply
  9. Edward Goss Sr./First City Capital Corporation CEO

    We need FDA aprroval now.

    Dr. Marvin Berman of Plymouth Meeting Pa. should be funded to treat Dentia!

    September 19, 2010 at 17:18 | Report abuse | Reply
  10. Rabbi Morey Huckleman//Great Neck New York

    We need the involvement of Think Tanks such as Wellington Institute.

    September 19, 2010 at 17:19 | Report abuse | Reply
  11. Nancy Sharon Axilbund

    I agree with Rabbi Huckleman!

    September 19, 2010 at 17:20 | Report abuse | Reply
  12. Nancy Sharon Axilbund

    Liz Cowen should eat a Big Mac and get a Life!

    September 19, 2010 at 17:21 | Report abuse | Reply
  13. Rick Columbus

    I was on Avandia for several years. When the Avandia scare started, my doctor switched me to Actos. Two weeks ago, my bladder, prostate and surrounding tissue was removed due to Bladder Cancer, so if you're going to suggest a connection between Actos and Bladder Cancer, I'd sure like more information.

    September 20, 2010 at 14:07 | Report abuse | Reply
  14. DiabetiesCaretaker

    Well... in this case your kind of crippled either way. Take the meds (generic class) and control your blood sugar and get bladder cancer. Don't take the meds have a diabetic stroke, or slowly die while your body shuts down 1 system at a time.

    September 20, 2010 at 15:43 | Report abuse | Reply
    • StayAwayFromPatients

      First of all you cannot even spell the disease correctly so it makes me wonder.What generic medications are you talking about the biguanides (metformin) or sulfonylureas (glyburide) or insulin which have not been linked to bladder cancer.Actos which has no generic HAS been linked to bladder cancer.I hope you can read the prescription labels especially if the insulin has a sliding scale instructions because your basic reading comprehension is about at the 6th grade.Keep trying but don't kill anyone okay?

      September 22, 2010 at 03:11 | Report abuse |
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  17. Elenita

    This problem has not gone away, as you know from the news now. And yeah, StayAwayFromPatients is right, there is no generic that I know of for Actos. Also, a generic wouldn't solve the problem of the bladder cancer risk: http://bit.ly/iQXOxg

    June 21, 2011 at 13:45 | Report abuse | Reply
  18. Roberto

    Ok so the agency announced preliminary five-year data shows Actos can increase the risk of bladder cancer in patients using the drug long-term. Why wasn't this data detected during clinical trials? They rush these drugs to market too quick making us the guinea big for their profits. Source: http://www.actosinjurylawyers.com

    July 16, 2011 at 22:06 | Report abuse | Reply
  19. Roberto

    Really? Since when does the benefit outweigh any risk of bladder cancer? Let alone cancer alone. In essence the doctor community is saying, we'll prescribe you what you need we think you need it but it could kill you. Someone needs to prescribe these people a regiment of healthier foods and a little exercise. http://www.actosinjurylawyers.com/actos-bladder-cancer-link/

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Get a behind-the-scenes look at the latest stories from CNN Chief Medical Correspondent, Dr. Sanjay Gupta, Senior Medical Correspondent Elizabeth Cohen and the CNN Medical Unit producers. They'll share news and views on health and medical trends - info that will help you take better care of yourself and the people you love.