September 23rd, 2010
11:34 AM ET

Diabetes drug Avandia restricted by FDA

The controversial diabetes drug Avandia will stay on the market, but the U.S. Food and Drug Administration restricted its use to patients with type 2 diabetes who cannot control their illness with other medications.

The restrictions are based on studies showing an increased risk of serious heart problems, including heart attacks and strokes, in patients taking Avandia, the FDA said Thursday.

Just minutes after the FDA posted its decision on its website, its European counterpart, the European Medicines Agency, announced that it’s going further and suspending approval for the marketing of Avandia in Europe. If the decision is finalized by the European Commission, the drug will be removed from the European market, along with two medications Avandamet and Avandaryl that combine Avandia’s active ingredient with other drugs. Dr. Hans-Georg Eichler, the agency’s senior medical officer, said he expects a final decision within “a few weeks.”

The FDA’s move runs counter to the recommendation of a senior scientist, Dr. Gerald Dal Pan, who advised the agency to pull Avandia from the market altogether. Dal Pan heads the FDA’s Office of Surveillance and Epidemiology, which oversees the safety of drugs that have previously been approved.

In explaining her decision, FDA Commissioner Margaret Hamburg said the agency “is taking this action today to protect patients, after a careful effort to weigh benefits and risks. We are seeking to strike the right balance to support clinical care.” Approximately 600,000 Americans take Avandia, and those patients may continue taking the drug, Hamburg said, “if they are benefitting and they acknowledge that they understand the risks. Doctors will have to attest to patients’ eligibility.”

Avandia is used to control blood sugar in type 2 diabetics. It was approved by the FDA in 1999 and by 2006 was widely prescribed, with sales of more than $3 billion in 2006. But the drug came under close scrutiny in 2007, when Dr. Steven Nissen, a cardiologist at the Cleveland Clinic, published an analysis which showed a 43 percent increase in heart attacks for patients on Avandia. The finding led the FDA to order GlaxoSmithKline (GSK), the drug’s maker, to conduct a thorough study of its safety. The full results of that study – known as RECORD – were made public last year. While GSK said the safety data was reassuring, the study came in for blistering criticism at a July meeting of an FDA advisory committee, where Dr. Thomas Marciniak, an FDA scientist who reviewed the data, said GSK ignored several cases of patients who suffered severe adverse effects.

In June, another FDA scientist, Dr. David Graham, published an analysis which came to similar conclusions as Nissen had. The accumulation of negative findings led the advisory panel to recommend a clampdown on use of Avandia, although the panel’s vote was split, with 17 in favor of restrictions, while 12 members voted to pull it from the market entirely and three said no action was needed.

On Thursday, the FDA ordered GSK to develop a program to ensure that access to Avandia is tightly controlled. It also ordered the company to pay for an independent review of the RECORD study, and ordered a stop to another study comparing Avandia with Actos, a competitor’s drug.

Nissen, the Cleveland cardiologist who became the drug’s most well-known critic, sounded a mixed note after hearing of the decisions. “It’s taken too long to stop the use of a drug that clearly was harming people. We’ve got to fix this system.” At the same time, he said he’s satisfied with the FDA and European moves. “The use of Avandia and related products will essentially cease in the U.S. and Europe. I will anticipate that 99 percent of the use of this drug will cease worldwide.”

Others who have studied Avandia were more critical. Dr. John Santa of Consumer Reports Health called the FDA’s failure to withdraw the drug, disappointing. “It’s frustrating for us to see there are still several hundred thousand patients on this,” Santa said. “We have concerns that many of those people don’t realize there are other alternatives that are more effective and less risky.”

Paul Thacker, who as an investigator for Senator Charles Grassley (R-Iowa) and the Senate Finance Committee accused GSK of burying negative information about Avandia, said the FDA is being too timid. “When you look at all the evidence provided by Congress to the FDA about misconduct by GSK, and when you look at the numerous independent studies saying that the drug is harming patients, what evidence does the FDA want to have to make a decision that a drug needs to be yanked? What evidence do you need?” Thacker left Grassley’s staff this month for a position with the Project on Government Oversight.

FDA Commissioner Hamburg and Dr. Eichler of the European Medicines Agency each downplayed their split, saying the two agencies agreed on Avandia’s risks but chose different strategies to manage it. “We discussed the decisions with each other. These decisions were not made in isolation,” Hamburg said.

A slight note of discord came from Dr. Janet Woodcock, who heads the FDA division that evaluates medicines, who said “There is still considerable uncertainty of the magnitude and existence of this cardiovascular risk.” In a memo, Woodcock said that patients might still benefit from Avandia if they did not respond to other medications.

Medical groups warned that patients should not stop taking Avandia without first talking to their doctors. A joint statement from the Diabetes Society, the American Association of Clinical Endocrinologists and the Endocrine Society said stopping medication “can result in higher levels of blood glucose that may cause serious short term health problems and could increase the risk of long term diabetes-related complications.”

In a statement, GSK said it still has faith in its product. Wrote Chief Medical Officer Dr. Ellen Strahlman, “The company continues to believe that Avandia is an important treatment for patients with type 2 diabetes and is now working with the FDA and EMA to implement the required actions.

Type 2 diabetes is a condition that affects the way the human body metabolizes sugar. Symptoms include weight loss, fatigue, blurred vision, frequent urination, and increased hunger and thirst. There is no cure, but patients can manage their conditions with proper diet and exercise; medications or insulin therapy may also be needed, says the Mayo Clinic.

About 8 percent of the U.S. population - or nearly 24 million people - is living with diabetes, and 90 percent of those cases are type 2, according to the National Diabetes Information Clearinghouse.

Here are alternatives for people with diabetes if you are concerned about Avandia.

soundoff (339 Responses)
  1. huhj

    Drugs are bad...mmmkay

    September 23, 2010 at 11:48 | Report abuse | Reply
    • slorgg

      Yeah especially if the drugs are coming from agreements with giant mega corporations and corrupted government. I can be pretty sure that after Codex Alamentarius went into action on Jan, 1, 2010.

      I don't trust a single thing the big pharma is pushing out including vaccines. When you realize that the richest shareholders in the world are of the opinion that there are too many people on this planet. YOU DO THE MATH!

      September 23, 2010 at 12:50 | Report abuse |
    • Andrew Messenger

      This is one of these where they have the commercial, and it talks about how this drug does all this GREAT STUFF for you. Then they have to legally state all the BAD things that could happen if you take it, and they go on and on and on and on. Of course, that in itself is a product of the malpractice gone nuts in the health industry. Anytime someone sneezes, they sue and then all of a sudden we hear, "using Advandia might cause you to sneeze every once in a while" tacked to the end of the commercial.

      September 23, 2010 at 13:41 | Report abuse |
    • jalynne

      If that stuff causes people to make contracting sentences...i'll pas on the stuff. "Yes, Drugs are bad. All of drugs ave side effects.. Have you hear Moxxor? Moxxor is the powerful OMEGA 3 . Have no side effects. "

      September 23, 2010 at 14:13 | Report abuse |
  2. OMG

    Sooo they are gonna give it to only the people MOST at risk of serious complications????? Wow, $tuck on s2pid!

    September 23, 2010 at 11:54 | Report abuse | Reply
    • UCCF

      They're restricting it to people who have tried other things and failed. It's not the same as saying they're at the highest risk for complications. Essentially, Avandia is being positioned as a "drug of last resort" for people who are simply unable to control their diabetes using other medications – which is exactly the right thing to do if you think that Avandia has the most severe potential side effect profile of any of the diabetes medications.

      September 23, 2010 at 12:07 | Report abuse |
    • RG

      Not one doctor will prescribe this medicine, unless they don't carry malpractice insurance.

      September 23, 2010 at 12:48 | Report abuse |
    • MML

      To UCCF- I just want to say thank goodness there is a voice of reason on this board that is actually well informed on how medications and the FDA work. People would benefit from scrolling down the board and reading all of your posts. Suddenly pulling Avandia off of the market would be a huge detrement to the millions of people who are benefiting from it when other meds have failed and may potentially lead to shortages of similar meds for patients on other insulin sensetizing agents.

      September 24, 2010 at 11:42 | Report abuse |

    FDA in the business of murdering people.Id like to meet the retards who put these medications out in the first place.

    September 23, 2010 at 11:56 | Report abuse | Reply
    • ADiff

      Actually the FDA 'kills' far, far more people by over-regulating than by being too lenient. Lives would be saved by stream-lining the approval process and reducing FDA regulation. Making the process more costly and time consuming or more restrictive will actually end up killing a lot of people. Of course no one will blame the FDA for avoidable deaths from illness and injury that could have been prevented by treatments the FDA effectively denied them....so there's no political 'downside' to just letting them die, and killing still more. Advocates of increased regulation are engaged in an effort to the same ends....they're happy to end up with more deaths, as long as there's no 'smoking gun' to get all hysterical about....but at least for most individual regulatory advocates, unlike the FDA itself and the established large companies they protect from competition, do so simply out of ignorance, rather than malfeasance.

      September 23, 2010 at 16:53 | Report abuse |
  4. froggyalley

    That's kind of a dumb restriction. If someone's diabetes is uncontrolled they might need to try Avandia to see if that might work. duh. Ditch the drugs, get on insulin. It's much, much easier and gives the best control... and it is cheaper.

    September 23, 2010 at 11:57 | Report abuse | Reply
    • UCCF

      Not everyone's diabetes responds to insulin alone. That's in part why we have other drugs.

      September 23, 2010 at 12:05 | Report abuse |
    • SurRy

      Insulin alone is not the answer everyone. Google insulin resistance. Some people produce insulin but their body (for various reasons) is not able to utilize the insulin. Drugs like Avandia work by making certain receptors on the body's cells more responsive to insulin.

      September 23, 2010 at 12:44 | Report abuse |
    • ADD5

      You're absolutely correct, but then let's be consistent here. All FDA restrictions are dumb for the exact same reason.

      September 23, 2010 at 12:56 | Report abuse |
    • Name*Taylor

      Insulin is a drug and sometimes peole forget that. It's also a drug so dangerous that 2 nurses have to sign off when it's given to a patient in the hospital. Insulin is great for many people but it's not ok for everyone. Besides no drug is ever a substitute for eating right and exercising and even that's not always good enough

      September 23, 2010 at 16:43 | Report abuse |
  5. amlh

    That's just like the U.S.A, isn't it? Leave a dangerous drug on the market regardless of how dangerous it is....after all, selling it makes a crap load of money right??

    September 23, 2010 at 11:59 | Report abuse | Reply
    • Rich

      Don't demonize the country. Most of it is comprised of people who do not support this kind of behavior and only suffer from it, rather than deriving some kind of benefit.

      September 23, 2010 at 15:14 | Report abuse |
  6. Wot

    Why restrict now? Why not sooner? If not really urgent, try to avoid drugs as much as you can. There have been numerous proofs/events when FDA recalls drugs that have been in the market for some time and people have been taking the drugs, believing it's safe. Human are prone to errors, and therefore man-made drugs are imperfect and may cause terrible consequences. Take drugs with accepting the potential risks.

    September 23, 2010 at 12:00 | Report abuse | Reply
    • SDY225

      Do you have any alternatives to drugs made by humans?

      The herbal supplements have either been scientifically proven as worthless or have such random levels of active ingredients that even if you had the right diagnosis and indication you'd never be able to come up with a meaningful dose.

      September 23, 2010 at 12:50 | Report abuse |
    • Wot

      Responding SDY225: I said "if not really urgent", meaning that if you aren't really sick, I would suggest don't take drugs. I've seen Americans always taking medications without thinking twice even though unnecessary. Such a life style could be dangerous. I do take drugs, but I always make myself aware that this drug could have risks, and I should accept that.

      September 23, 2010 at 13:55 | Report abuse |
  7. KRS

    Having Type II diabetes – I wish it was that easy.

    September 23, 2010 at 12:03 | Report abuse | Reply
  8. Drazul

    no wonder Europeans live longer than Americans now...they dont have to die at the hands of the FDA fiddle-f@rting around with "gee is this bad or not...maybe we shouldnt allow it anymore...but were making a fortune from the pharmaceutical companies...ok it stays in production"

    September 23, 2010 at 12:03 | Report abuse | Reply
  9. EB

    That's clearly not true for EVERY diabetic...

    September 23, 2010 at 12:03 | Report abuse | Reply
  10. Fixer2010

    Are you serious?

    September 23, 2010 at 12:03 | Report abuse | Reply
  11. MaryAnn

    This pill was never in danger of being pullled ...WHAT A SCAM.

    The FDA is a dangerous agency that sellout the people for kickbacks and are in the pockets of the billion dollar drug makers.

    This drug has caused thousands of heart attacks but gives the drug maker 4.4 billion a year!! so it stays

    A filmmaker has been reversing diabetes WITHOUT MEDICATIONS in now 10 countries but the FDA does not promote this
    just google SPIRIT HAPPY DIET or see here http://spirithappy.wordpress.com

    September 23, 2010 at 12:04 | Report abuse | Reply
    • ADD5

      Has the drug provided no benefit at all for any of its million of voluntary customers? Or you just don't know or don't care? Rather, you'll engage in half-truth statements in order to manipulate others to follow you personal preferences and ideas.

      September 23, 2010 at 12:53 | Report abuse |
  12. Brian

    Too little too late for my grandmother who died while taking Avandia.

    September 23, 2010 at 12:04 | Report abuse | Reply
    • lab

      Please accept my sincere condolences for yourself and your family.

      September 23, 2010 at 12:10 | Report abuse |
    • linda

      I totally agree; my dad died in Feb of 2009 after taking Avandia for two years. He had a massive heart attack despite having no history of heart disease in his family; he was only 60. Restricting or even pulling this medicine comes to little to late for those of us who lost someone dear to us. Like all other medicines, everyone wants a quick fix for an illness, but no one wants to wait for true testing to be done before giving approval. I know my dad's physician was quick to prescribe this medicine even though my dad's was a minimal diabetic whose sugar was rarely above 130 even without the medicine. Those of you who care to comment and haven't been impacted by the results of this medicine have no idea how difficult it has been for those of have to know that people are still being given a medicine that can in turn cause their families to suffer the same kind of pain we suffer now.

      September 23, 2010 at 12:47 | Report abuse |
    • RG

      I survived, but not without a quadruple bypass. I was only on Avandia for 2 months, had 2 heart attacks.

      September 23, 2010 at 12:52 | Report abuse |
  13. Dorian Colaneri

    How can so many drugs be prescribed for so many years and to so many people, without manufactures knowing the real effects and harm that's caused to un-suspecting patients. What are clinical trials for unless the trials are also, bogus and the number of deaths and side effects withheld and hidden in secrecy as cigarette makers did years ago.

    What's next on the list and for God sake, what took the FDA so long to respond, they've known about Avandia for so time now. Drug manufactures are poising American's by the millions legally.

    September 23, 2010 at 12:08 | Report abuse | Reply
    • UCCF

      It's a balancing act – you've got 50% of people complaining that the FDA takes too long to approve drugs (much longer than in Europe) that might be potentially life-saving, and the other 50% complaining that the FDA lets drugs through to market which are later revealed to have side effects. Blinded clinical trials are the gold standard for determining safety, but not all safety issues show up in a short period of time. It may take years for the cardiovascular effects to take effect – do you wait to approve the drug until the safety profile is clearer (knowing that thousands of lives might be lost to diabetes who might otherwise have been helped if the drug were available), or do you approve now to help the diabetics but risk people dying from as-yet undiscovered side effects?

      And the real problem is – 20 deaths from heart attacks in people taking Avandia makes a much bigger media frenzy than 1000 deaths from diabetes in people who may not have died if Avandia were available.

      September 23, 2010 at 12:14 | Report abuse |
  14. lab

    After they sold zillions of these tablets to people who got the "drug du jour," they are now finding that Avandia is this dangerous? The drug companies KNEW BEFORE THEY GOT FDA RELEASE that it was dangerous. Some types of Type II are not easily controlled, but if you are LUCKY enough to have Type II (as opposed to Type I which is not a result of bad habits), you should be watching your diet, testing yourself more frequently than once/day (or forgetting to test at all), and getting off your fat butt and exercising. Remember, Omar the Tentmaker won't be in business too long if you don't let him. It's the responsibility of the patient to control Type II diabetes. Use of insulin is a cop-out for Type IIs. Those are the people who really just won't change their habits.

    September 23, 2010 at 12:09 | Report abuse | Reply
    • HardTruth

      Doctors and healthcare providers knew the risk of TZD class when they first came out...Your points on diet, exercise and lifestyle change should be highlighted....ACTOS is in the same TZD group DIABETICS .......DO YOU UNDERSTAND THIS? Get off your fat ass, watch your diet and make the changes in your life.........There are no magic pills that can help you if you eat a box of KRISPY KREMES..............

      September 23, 2010 at 12:19 | Report abuse |
    • HardTruth

      Diabetics we know when you have been cheating on your diet by your A1C....Keep pounding those doughnuts,cheeseburgers and other "healthy" "organic" foods...If I was your pancreas I would QUIT too! Blame everything and everyone for your 50 inch waistline! You are just big-boned right? You will start your diet tomorrow right? You will just 1 piece of chocolate chunk double fudge cake right?

      September 23, 2010 at 12:26 | Report abuse |
    • linda

      You might want to research a little more to find that there are many people diagnosed with Type II who are not overweight and do get out and exercise and still must control the disease. Type II is not limited to overweight people.

      September 23, 2010 at 12:50 | Report abuse |
    • The Chemist

      You might try and go back to your lab. Type II diabetes, has nothing to do with whether an individual is over the so called healthy weight. The individuals with type II diabetes that I know could run circles around most jocks, if they could properly use their bodies insulin. It's time to get off the weight issue and go back to real science rather than what is pleasing to the eye science. Not all that many years ago scientist were concerned about the Barnie doll image that was being placed before our children. why because it was unhealthy, well there are many of us that use science and find the ideal weights imagined by make beleive scientists are actually unhealthy, you see its a two edged sword. However not all illnesses are caused by execessve weight.

      September 23, 2010 at 19:56 | Report abuse |
  15. JBO

    You're an idiot.

    September 23, 2010 at 12:11 | Report abuse | Reply
  16. Dan

    EMA says the medicine should be discontinued but the FDA is happy killing Americans for financial gain. NICE! The pharmacist may as well give you a gun with your prescription.

    September 23, 2010 at 12:13 | Report abuse | Reply
  17. leslie morris


    September 23, 2010 at 12:19 | Report abuse | Reply
    • Snoop

      Well, now if a patient takes it and dies, they do so with full foreknowledge of the risks, and therefore, no lawsuit. Of course, their family will try, and tomorrow the ambulance chasers will be out with their "Did you take Avandia and suffer a heart attack?" trolling commercials. Fits right in with our sue-happy, something for nothing national psyche.

      September 23, 2010 at 12:51 | Report abuse |
    • linda

      Just a news flash for you; a large number of people taking this drug have died from massive heart attacks and it is still on the market. It has only been in the past 9 months that studies of these deaths have found the common factor in all of them was the use of Avandia.

      September 23, 2010 at 12:52 | Report abuse |
    • RG

      MY lawsuit was started in 2002, still waiting, the more news like this, the more the lawyers will get.

      September 23, 2010 at 12:55 | Report abuse |
    • rdc

      can you prove that?

      September 23, 2010 at 14:50 | Report abuse |
  18. smiley

    it's all a scam!!! i dont think they give these new drugs enough trial time...they're always in a hurry to push them out on the market so they can start making money...disregarding the human lives they are playing with!

    September 23, 2010 at 12:19 | Report abuse | Reply
  19. End EndTheFed

    Can a CNN moderator please remove EndTheFed's post? It's not only bad science, it's DANGEROUSLY bad science that could hurt a diabetic who is foolish enough to attempt to follow it.

    September 23, 2010 at 12:21 | Report abuse | Reply
    • ADD5

      Heard you the first time. What are you, hired by the Fed or something. Get lost!

      September 23, 2010 at 12:58 | Report abuse |
  20. Dorian Colaneri

    UCCF are you serious? If a drug is known to manufactures before it is released to market to cause more harm then benefit to a patient, are you really saying that it should still be prescribed? One would be better off dying from the disease, you'll live longer rather then be prescribed a drug that's sure to check you out early.

    There are alot of great drugs that produce wonderful benefits, but let's not forget, it's a business and the bottom line is profit and lot's of it in the drug business legal and illegal.

    September 23, 2010 at 12:21 | Report abuse | Reply
    • UCCF

      For one thing, we don't "know" that a drug will cause more harm than benefit to any particular patient, and it's not "sure to" check you out early. The risk of serious CV side effects for a drug like Avandia is probably <1% – in other words, give it to 1000 patients, and fewer than 10 should be expected to develop CV problems. So is it worth it making the drug available to those 1000 patients, knowing that a random group of 8 or 9 will likely have CV consequences? That's a benefit/risk decision that the company and the FDA have to make, based largely on:

      – the severity of the side effect (e.g., no one would care if 8-9 people developed a little skin rash);
      – the severity of the underlying condition (e.g., cancer drugs get a lot more side effect leeway than drugs intended to treat the sniffles); and
      – the effectiveness of the medication (e.g., if Avandia promised a 100% diabetes cure, we would tolerate more severe side effects than if it just slightly improved someone's diabetes).

      Put it this way – if we had a drug that would cure 100% of otherwise incurable and fatal cancers, but 5% of patients who took the drug would develop fatal heart attacks, should the drug be available on the market? You're saving 95 out of every 100 patients from dying from cancer, but killing 5 of them prematurely. If you had cancer, would you want to take that risk – it's basically rolling a 20-sided die, and if any number comes up except 20, you're cured and live a normal lifespan? If you were the FDA, would you want people to have the option to take that risk – eliminating a terrible disease at the known cost of 5% of people who are being treated?

      For the most part the FDA (particularly recently) is coming down on the side of pulling drugs or restricting their use if safety issues arise. But these are not cut-and-dried questions.

      September 23, 2010 at 12:43 | Report abuse |
  21. MND2

    Not all insulin helps with controlling T2D ... Some of us have to use drugs AND insulin to control it... but there are some out there that are just diabetic type 2 because they are overweight. Simply put... lose the weight and get control of your life back... there is also Gastric Surgery which guarantees 70% weightloss by end of year 1.. IF you stick with the plan... but then again...........IF -

    September 23, 2010 at 12:24 | Report abuse | Reply
    • Dorian Colaneri

      Weight is a big misconception concerning type II diabetics and has more to do with genetics. I'm not disclaiming the need to lose weight and exercise, but before learning I was diabetic, I played racquetball twice a week, boxed and ran several miles. I gained more weight after I became a type II diabetic.

      The hardest part about being diabetic, is that one has to remember that every single thing you eat turns into sugar and is stored in the body. So, if your 35, 40, 50 years old, all those years of good or bad habits most now change. So, weight, not just the only under lining cause, find your great, great grandfather and send he a cupcake, tell him thanks for the disease.

      September 23, 2010 at 12:44 | Report abuse |
  22. Wondering

    My 89 year old mother who had a severe heart attack quite some time ago is on Avandamet. Which is, I think, Avandia and metformin together. Is that safe or not.

    September 23, 2010 at 12:25 | Report abuse | Reply
    • Snoop

      Or, the fact that she's 89 could just mean that she's old and it was natural.

      September 23, 2010 at 12:47 | Report abuse |
  23. Howard

    Avandia is a perfectly good drug. The studies that killed Avandia was a really shitty meta analysis by a guy who (in my opinion) is trying to get a job as the head of the FDA.

    Actos is in the same class as Avandia, so basically all this does is it gives more money to one drug company over another. I would prescribe both, but I guess the FDA is giving in to public fear rather than looking at the actual evidence in good, large, and randomized trials.

    September 23, 2010 at 12:28 | Report abuse | Reply
    • TESS


      September 24, 2010 at 06:49 | Report abuse |
  24. LawSuitOnDaway

    We are settling our lawsuits with free twinkies, ho-hos, Big Jerry's double chocolate liquid fudge Ice-cream. Who wants some?

    September 23, 2010 at 12:30 | Report abuse | Reply
  25. Dorian Colaneri

    Metformin, reduces the amount of sugar made by the liver, limits the amount of sugar absorbed into the body and makes insulin receptors more sensitive (helping the body respond better to its own insulin). With the exception of a few emergency runs to the rest room, I've taken it for 7 years without death so far, but who knows someone may find me tits up one day with a Metformin pill bottle next to me, in the rest room.

    September 23, 2010 at 12:30 | Report abuse | Reply
  26. MaDcoW

    Y'all Bunch of sick people cos of bad "HABBITS!" Stop the sweets, Booze, smoking and Fats!
    Work out everyday! Have lots of SEX!!

    September 23, 2010 at 12:36 | Report abuse | Reply
  27. smiley

    you'd probably spend less money going to the gym or hiring a personal trainer, then you would on these drugs...so why keep spending your money on something that might kill you eventually....just a thought:)

    September 23, 2010 at 12:37 | Report abuse | Reply
  28. timd

    Snakeoil is snakeoil. The only difference is now instead of schilling it from the back of wagon, they are doing it on TV during primetime. Good food and excercise would go a long, long way to fixing the problems that plague the US. Keep in mind that big pharma has a fiduciary responsibility to their stockholders and therefore has a vested in interest in making sure that you stack sick to keep their quarterly profits rolling in. Why is capitalism so great again?

    September 23, 2010 at 12:37 | Report abuse | Reply
  29. John

    Why call it DIabetes???
    It should be called LIVbetes..

    September 23, 2010 at 12:40 | Report abuse | Reply
  30. The_Mick

    It's interesting that the FDA first claimed, a month ago, that Avandia did nothing other drugs couldn't do, but now are allowing Avandia in cases where other drugs don't work! As I mentioned in these comments on that previous claim, I quit taking Avandia 3 years ago -mainly because of the weight gain it causes- and I've struggled with a combination of meds to get an under-7 A1C test where Avandia gave me sub 6.5 tests. My extremely able PCP, who my research-nurse sister claims is "sent from God," takes Avandia. I've lost 30 lbs while taking other-than-Avandia (beyond the water weight) without improving my A1C tests, so I'm not sure my continued weight loss will solve the problem. So I'm glad Avandia's available in case my current meds stop being working.

    September 23, 2010 at 12:42 | Report abuse | Reply
    • Dave Eaker

      Please try Moxxor http://WWW.mymoxxor.com/pahman

      September 23, 2010 at 13:13 | Report abuse |
  31. Karen

    Diabetes Mellitus Type 2 (DMT2) is the result of a long term and worsening insulin resistance. Insulin resistance is caused by consuming too much carbs too often. So if you reduce or even avoid starch and sugar, you might be able to control diabetes without taking drugs. Read more about carbs and diabetes here http://bit.ly/9NUC69.

    September 23, 2010 at 12:43 | Report abuse | Reply
  32. 4sanity

    Avandia (Rosiglitazone) has side effects just like EVERY OTHER drug (you know those annoying little disclaimers at the end of each TV commercial). So by most people's reasoning on this board ALL DRUGS should be pulled off the market.

    Other thiazolidinedione drugs (class that Rosiglitazone belongs to) have been pulled in the past because of their side effects. Rosiglitazone however was the best tolerated and so stayed on the market, and increased heart/stroke effects take years to properly (i.e. scientifically) assess. But often you don't see these effects until there is a large enough pool of users (recruited into long term studies). The FDA tries to objectively balance these risk and benefits. Even in this case, the relabelling acknowledges that for some patients it can still be prescribed because benefits outweigh the risk. If other medications don't effectively work, the complications from uncontrolled diabetes (including death) are worse than the increased risk of heart attack/stroke.

    Bottom line – there are no magic pills that cure you. Most medications (including Avandia) are for chronic management of symptoms and that means there will always be a downside to prolonged exposure for some individuals.

    September 23, 2010 at 12:45 | Report abuse | Reply
  33. Gia

    This is the FDA practicing what they'll have to do after the approve the lab-created 'salmon'...

    September 23, 2010 at 12:46 | Report abuse | Reply
  34. ADD5

    People, It's all about trade-offs. You don't have to agree to take any drug that you deem unsafe or that its potential benefits outweigh its costs (and risks). This is why there are suppose to be doctors, so you they can help you make an informed descision regarding your own body.
    But apparently, most people [here] don't agree. They have apparently acknowledged and agreed that their bodies belong to the FDA and the government. The FDA should weigh all costs and benefits for you and everybody else regardless of what they think about it. Apparently, the FDA will decide what risks and how of it to take. Why not have the FDA or some other agency dictate all the other aspects of your life. Certainly, there are risks their too.

    September 23, 2010 at 12:49 | Report abuse | Reply
  35. PancreasOnStrike

    Dear Beloved Owner,

    I QUIT!!!!! Take this job and shove it! I cannot produce enough INSULIN for you any longer and I don't think a thailand sweatshop either.After your intake of a box of Krispy Kremes and Mountain Dew I thought I was done for the day.Then at around noon 3 Big Macs and French Fries washed down with pepsi I thought I was going to pass out.Then when I get the blood sugar down to a respectable number the candy comes dowm at 2:30P.M....Don't get me started on the pizza at dinner with the chocolate cake...Then all the snacks at night...

    I QUIT!!!!!!!


    your PANCREAS!!!!

    September 23, 2010 at 12:50 | Report abuse | Reply
  36. MaDcoW

    Just stop sending comments and exercise and eat well!!! Why are sick people so hard headed?????

    September 23, 2010 at 12:51 | Report abuse | Reply
  37. Tiffany H

    While you guys are blaming the FDA not I bet you are the same people that are screaming people are dying while the FDA take its sweet time to approve a drug. The American public is just a bunch of flip floppers. It's uber frustrating and the FDA is honestly in a no win situation. Please people think. And lawsuits hurt everyone.

    September 23, 2010 at 12:53 | Report abuse | Reply
  38. JMD

    lab & HardTruth – could the two of you please go play somewhere else, your ignorance is distracting the rest of us.

    If either of you would do a second's worth of research, you'd know that the whole thought process behind Type 2 Diabetes is changing. It isn't LUCKY to have it. It isn't about choosing a lazy lifestyle and eating crap. There is new research and new thoughts by everyone from pharmacists to endocrinologists that risk factors such as being born premature (which I was) or having a mixture of Type 1 and Type 2's in your family (I have both) can nail you with Type 2 whether you're a pound overweight or choose to be a vegan! I've been part of a study at my hospital for the past two years about this. I take my meds, I exercise and have lost weight, I've changed my diet, and guess what? I was told I'm probably always going to have to be on some kind of medication because of genetics & that it'll probably come back worse as I get older. So, kindly put a cork in your really rather disturbing ranting. Seems you both have issues that have nothing to do with this topic.

    As for the misinformed that keep pushing insulin as the cure all for Type 2's? Insulin is the last resort for Type 2 diabetics that can't be controlled with oral medications! No doctor takes a Type 2 diabetic and shoves insulin at them as the first step or even the second or third! The goal is to get off medication – not stuck on insulin.

    September 23, 2010 at 12:55 | Report abuse | Reply
  39. dtg

    I too am disappointed by the FDA...Too little too late for my father who die from massive heart attack 3 years ago after taking this nasty drug. I'm disgusted!

    September 23, 2010 at 12:56 | Report abuse | Reply
  40. 4sanity

    And for those that disparage the FDA, your sense of indignation and anger is misplaced. FDA does a fantastic job of reviewing and vetting what comes to market. Typically less than 1 % of drug candidates ever make it because they fail FDA mandated clinical trials for effectiveness and safety. And contrary to what some here claim, it takes YEARS of EXPENSIVE testing before drugs make it to the market.

    Do some unsafe drugs make it to the market as prescription medications ? Sure. Not even the FDA is perfect. But I'd like to know what all the critics suggest as a better alternative to independent peer review ? And if you're for extra, prolonged testing, don't complain when your medications costs skyrocket even more. You can't have it both ways.

    September 23, 2010 at 12:57 | Report abuse | Reply
  41. michael

    Good example of companys pushing there way into the market. It's all about the money . It will be company's that do you in !

    September 23, 2010 at 13:00 | Report abuse | Reply
    • Dave Eaker

      In 1981, following lobbying from US drug companies who were threatened by the popularity of the health supplement, US lawmakers banned the importation of green lipped mussel extract, destroying the export market virtually overnight.

      The ban was lifted in the 1990′s – green mussel extract can now be imported and sold in the USA again provided claims are made as to it’s effectiveness in treating arthritis, osteoarthritis, joint pain,diabetes and any of the other known inflammatory conditions.

      Moxxor is wonderful OMEGA 3 Please click my website http://WWW.mymoxxor.com/pahman

      September 23, 2010 at 13:30 | Report abuse |
  42. Tom

    Does anyone know a good attorney I have suffered a heart attack in 2006 while taking avandia. Please help.
    I live in North Dakota.
    Thank you.

    September 23, 2010 at 13:04 | Report abuse | Reply
  43. Dorian Colaneri

    UCCF, very good point and received respectfully. Bottom line here is that there are no real cures, only medications to help control or reduce as much of an illnesses effects as possible. As a type II diabetic, I personally recommend to all diabetics who truly understand how difficult it really is to control, is to seek out more natural foods, good dieting and exercise. (And no I didn't exercise this morning)

    Those that are writing comments about a disease they don't understand should not deter you in any way. Since, I am not over weight and every comment that is derogatory seems to focus on weight, I can tell you that weight is not the only factor and the disease has more to do with genetics then, people thinking every diabetic is sitting around eating biscuits and gravy everyday. (Ahh' anyone got a Pepsi out there?)

    September 23, 2010 at 13:05 | Report abuse | Reply
  44. Dave Eaker

    Yes, Drug companies want to make billion money. EVEN They paid money US lawmakers to prevent other businesses to make better medicines or better health supplements FDA is real joke.
    You might not hear about Moxxor...Green lipped mussel...p[powerful OMEGA 3 in the world

    Please read the message below...........
    In 1981, following lobbying from US drug companies who were threatened by the popularity of the health supplement, US lawmakers banned the importation of green lipped mussel extract, destroying the export market virtually overnight.

    The ban was lifted in the 1990′s – green mussel extract can now be imported and sold in the USA again provided claims are made as to it’s effectiveness in treating arthritis, osteoarthritis, joint pain and any of the other known inflammatory conditions. Also will help treating diabetes.

    Moxxor has no side effects... Please check my website http://WWW.mymoxxor.com/pahman

    September 23, 2010 at 13:09 | Report abuse | Reply
  45. RFALLER316

    WONDERFUL! Anything that can get this "medication" off the market would be great!. i started taking this medication and one week later i was hospitalized. i was hospitalized 4 times in 6 months last one for 16 days. i still dont feel back to where i was before. i am currently in the Avandia class-action case. i would rather have it taken off the market then get a settlement.

    September 23, 2010 at 13:09 | Report abuse | Reply
  46. amy

    For those of you telling everyone to get off their butts let me share this with you. I am 5'4" and 132 pounds. I got severe gestational diabetes in my first pregnancy that became type 2 after the birth. I only gained 15lbs in my pregnancy (and only 5lbs in my second). I have always been active and eaten well but even with living a healthy lifestyle my sugars need to be controlled with medication. Yeah some people are fat and lazy, but not everyone. Sometimes you just have bad genes. I took avandia for a little while but switched to insulin for better control. I feel for those kiled and/or injured by this drug.

    September 23, 2010 at 13:09 | Report abuse | Reply
    • Meryl

      I agree...I walk 3 times a week.I am 5'3" and weigh 145 pounds. I am pre-diabetic and was prescribed metformin 500 mg. My dad was diagnosed with diabetes when he was 77 so it can be bad genes...

      September 23, 2010 at 15:09 | Report abuse |
  47. Bob

    How many people died, while the FDA fiddled with this knowledge..

    September 23, 2010 at 13:11 | Report abuse | Reply
  48. Mitchell


    September 23, 2010 at 13:25 | Report abuse | Reply
  49. SF

    Get off the drugs, go exercise and stop eating crap. The only side effects are fatigue, weight loss, and results. If you ask me, that's a MUCH cheaper and safer alternative than the mass amount of advertised drugs our country is being prescribed. But i guess that is just too easy of a solution and doesn't create much of a profit for big pharm.

    September 23, 2010 at 13:27 | Report abuse | Reply
    • Beanie

      Some people gain weight for reasons that have NOTHING to do with poor lifestyle choices: if one can't stay active because of chronic knee and hip problems (that often persist even after surgery), one can easily gain 25+ pounds even on a strict diet from the relative inactivity. Certain medications, such as tamoxifen (breast cancer) and other cancer-related drugs, depression/anxiety/bipolar meds, nerve/neuropathy meds, steroids, and a host of others – some of which are taken in combination since one illness can often beget another – can also cause one to gain weight. It's hard to exercise when one is ill and/or in severe pain. Some people have serious glanduar or thyroid issues that are not well controlled by prescription drugs, assuming the person in question can afford it. Furthermore, 1 in 7 Americans live in poverty and can't afford healthy food. Finally, there are a number of highly-regarded academic and medical studies that indicate obesity has a strong genetic component (i.e., two people can eat the same amount and exercise similarly (or not at all) and one person will be thin and the other heavy). So, before you assume that everyone who's overweight is in this situation due to poor lifestyle choices, think again. Frankly, I feel compassion and sympathy for those who took Avandia because they trusted their doctor, the manufacturer and FDA, and became very ill or died as a result of doing so, especially if the manufacturer knew about the risks in advance. Metformin, an older, cheaper and apparently less harmful drug (it has been on the market 30+ years) may be a much better option for people with Type II diabetes who need to lower their blood sugar.

      September 23, 2010 at 17:19 | Report abuse |
    • Beanie

      Some people gain weight for reasons that have NOTHING to do with their so-called lifestyle choices: if one can't stay active because of chronic knee and hip problems that often persist even after surgery, one can easily gain 25+ pounds, even on a strict diet, from the relative inactivity. Certain medications, such as tamoxifen and other cancer-related drugs, as well as depression/anxiety/bipolar meds, nerve/neuropathy meds, steroids, and a host of others – some of which are taken in combination since one illness oftens beget another – can also cause one to gain weight. It's hard to exercise when one is sick and/or in severe pain. Other people have serious glanduar or thyroid issues that are not well controlled by prescription drugs, assuming they can afford them. Moreover, 1 in 7 Americans live in poverty and can't afford nourishing, healthy food. Finally, a number of highly-regarded academic and medical studies indicate obesity has a strong genetic component (i.e., two people can eat the same amount and exercise similarly (or not at all) and one will be thin and the other heavy). Before you assume everyone who's overweight is in that situation because they lack discipline, think again. Frankly, I feel compassion and sympathy for people who took Avandia because they trusted their doctor, the manufacturer and the FDA and became very ill or died as a result of doing so, particularly if the manufacturer knew about the risks in advance. Metformin, an older, cheaper and apparently less harmful drug (it has been on the market 30+ years) may be a good option for people with Type II diabetes who need to lower their blood sugar. Talk to your doctor.

      September 23, 2010 at 17:27 | Report abuse |
  50. matt

    People need to focus on losing weight. The drug doesn't cause a heart attack, but being overweight and never exercising increase. s

    September 23, 2010 at 14:01 | Report abuse | Reply
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