Diabetes Self-Management Blog

It all began three years ago, when a study published in The New England Journal of Medicine found that rosiglitazone (brand name Avandia), the popular drug for Type 2 diabetes, increased the risk of heart attack among those analyzed by 43%. The US Food and Drug Administration (FDA) responded by adding a new warning to the label of the drug — as well as to that of competitor drug pioglitazone (Actos) — and calling for further investigation, but it recommended that Avandia stay on the market. Later that year, more studies suggested that Actos did not carry the same heart attack risk as Avandia. Another study showing that Avandia increased the risk of overall death — a finding not supported by the other studies — caused Avandia’s reputation, and sales, to fall even further.

Now, Avandia is in the news again thanks to a New York Times article detailing internal, confidential FDA reports in which some reviewers recommended that Avandia be removed from the market. The reports were prepared for an advisory committee on Avandia, which has not yet issued its recommendations for how the agency should proceed based on the latest research. Meanwhile, a report just issued by the Senate Finance Committee finds that Avandia’s manufacturer, GlaxoSmithKline, “attempted to intimidate independent physicians” who sought to publicize Avandia’s risks and “focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk.” The Senate committee’s top Democrat and Republican, Max Baucus of Montana and Charles Grassley of Iowa, respectively, sent a letter to the FDA suggesting that participants in an ongoing trial involving Avandia might be exposed to an unreasonable risk. Grassley also asserted that safety officials at the FDA did not have enough power, since those originally responsible for approving a drug are likely to defend that decision rather than come to new conclusions regarding safety.

Meanwhile, GlaxoSmithKline issued a statement and then a longer “White Paper” dismissing the findings of the Senate Finance Committee, saying that the report cherry-picked evidence and made conclusions best left to an agency with expertise like the FDA. Some outside groups now appear conflicted on Avandia; as reported on MedPage Today, the American Heart Association and the American College of Cardiology issued a joint advisory supporting the ongoing prescribing of Avandia as deemed appropriate by doctors — but the American Heart Association also separately published a dissenting piece by a cardiologist, recommending that prescribing Avandia be discouraged.

What do you think — was it right of The New York Times to reveal the contents of an unofficial, internal FDA report? Should the FDA be restructured to give safety investigators more power over drugs already on the market? How high — and how clear — should the risk of a serious side effect, like heart attack, be to remove a drug from the market? Was it appropriate for the Senate Finance Committee to investigate GlaxoSmithKline’s handling of Avandia? Is it appropriate for drug companies to try to convince prominent doctors and researchers not to criticize a drug?

Do you take Avandia — or would you if your doctor recommended it? If you take it, are you satisfied with it? Leave a comment below!

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Comments
  1. I talked to my doctor the first time the report came out about heart problems. He wanted me to stay on it but I said I wanted to try something else. I tried 2 different meds and nothing seemed to work very well. I went back on it and so far I have had no problems that I can tell, but who knows what is happening inside us.

    Posted by James Fellows |
  2. I discontinued Avandia when the first adverse puilicity came out. I am now taking Actos and wondering if it is safe..

    Posted by Marge Chandler |
  3. I have been on Avandia now for 5 years, and have had no heart related problems what so ever from this drug. I do see a cardioligist for high cholestrol and have had a completed heart check up by the means of a stess/echo test and there are no problems with my heart. Metformin didn’t work for me and my doctor switched me to the Avandia which was a life saver for me. I have been considered a non diabetic because the Avandia,along with diet have helped keep my levels at a very tight control. My numbers weren’t being controlled at all on the Metformin and I had very nasty side effects from it no matter what dosage I was put on. I totally disagree of ever taking Avandia off the market. I have talked with several doctors who also agree with me. I believe it should be left up to each and every patient who is on it to make their own decision to stay on it or not. For me the benefits out weight the risks. And when the study was done how many of those people in the study had undiagnosed heart problems to start with, no one really knows. So to pull a very good drug in my opinion from the market is totally nuts. Why should we trust the government in our medical drug issues when they are the same people who are trying to destroy our health care coverage in this country. People are told what side effect their are to any and all drugs that we put into our bodies, and that decision to take them should be left up to the patient and their doctor in making the best and right medical decision for their treatment for any kind of disease including diabetes. I’ll continue to take Avandia until something should change which would then be better for me to stop and or switch medications. I am very satisfied with Avandia.

    Posted by E Bruce |
  4. I quit taking Avandia after this latest news release. I’m not taking any chances, we have enough problems with diabetes without adding more with a drug in question.

    Posted by Julia Graham |
  5. I have been taking Avandia for 10 years based on my doctors recommendation.
    I am satified with the results but unsure of the risks.

    Posted by Terence Kirkpatrick |
  6. Four years ago, my husband who has had very high cholesterol all of his life. and has been on drugs to combat it, was diagnosed with diabetes.

    His doctor put him on Avandia. As he has a very high risk for heart disease, he contacted his doctor after reading about the associated risks of heart failure and she was shocked. She had never heard of any negative reports about the drug. However, she removed him from it and put him on Metformin instead.

    Metformin has worked well. And, wow, it is a generic to boot! My guess is there are a lot of pharmaceutical reps pushing these drugs. They know the risks and know many of the generic drugs have far less risks.

    But they don’t make the big money after the patents run out!

    Posted by Sue Bennet |
  7. I have been on Avandia fo at least 10 years, I have not had any heart trouble,When I heard the bad things that they said about it I went off but my sugar went way up I went back on and I am back to nornal

    Posted by Thomas Ward |
  8. I took avandia for years and my cardiologist agreed I should stop taking it. (I happened to have an appointment with him the very same day the first report came out) Several months later, I averted total disaster by calling for an ambulance for some very unsubstantial symptoms of heart attack. I had not had one, but did have a 90% blockage of my right coronary artery. On the spot, I was given an angioplasty and 2 stents. I was told that had I ignored these symptoms, I could have had a severe heart attack, possibly that very night.
    Caused by avandia? Opinions vary. There are several class action suits. Fortunately, because I avoided the heart attack, I am not eligible to join any of these lawsuits.
    I do believe it should be removed from the market until further research proves it to be safe, such as what happened with metformin years ago. It was removed from the American market for a long time because of possibly related incidents of death. Only when it was proven to be safe was it allowed to be sold in the US again.

    Posted by Tami Breimann |
  9. Advandia trends to increase weight gain. I took it once and gained an enormous amount of weight in a very short period of time.

    I will never take Avandia or Actos again.

    Posted by Francine Kramer |
  10. When the original report on Avandia came out my MD told me it was up to me. Their Group had reviewed the drug and if it was working well for the patient it would be left to the patient to decide. Since I had about 105 days supply, I said I would look into it and let her know.

    I read the report in the New England Medical report and the information from the single individual that did the study. He used other reports and had no testing himself. If I received such a report in my business, I would have sent it back and had it completed or throw it into the circular file.

    What I did see is an individual that had an ax to grind or just needed to publish something.

    I have stayed on Avandia for 6 plus years and twice have reduced my Diabetic Medicine.

    By the way if you look into the reports on other Diabetes Medicines, there are no winners for safety!

    I am current off Avandia, only because I had to reduce dosage and the Joslin Clinic recommended Metformin.

    Posted by Harry Risso |
  11. A few years ago I was in a study between Avandia and Actos. They did not tell me wnat I was taking, said they will let me know when the study is over. Stll have not heard from anyone. I did pick up heart problem, but am not blaming it on them.
    Just would like to know what I was taking, the study was run out of Duram!
    Sincerely yours Giesela

    Posted by Giesela Schmitt |
  12. I took Advandia years ago and developed severe swelling of legs and feet. Have lost my mobility as a result. Bad Bad drug.

    Posted by Mag Brown |
  13. I took Avandia for quite a while, with, I thought no ill effects. When news first kept being flashed about the risks, my spouse kept saying I should quit. I spoke to my doc and he poo-poo-ed the news. I continued and, unfortunately, ended up having a heart attack and subsequent open-heart surgery. After that, I told the doc that I would no longer take the drug. He said that was not why I had a heart attack. That may be, but I was through taking the risk. And now, the news seems even worse. I feel I did the right thing for me.

    Posted by Charlene Sydow |
  14. I’ve been taking Avandia for years. No heart problems at all. In fact my doctor insisted that I get an ultrasound of my heart and it was clear. Maybe the folks that had increased risk were at high risk to begin with.

    Posted by Bob |
  15. I have taken both Avandia and Actos. Both medications worked wonderfully well for me in combination with metformin. I had already had one mild heart attack prior to the release of either drug. I discontinued Avandia because my insurance company (Aetna) cancelled coverage for that drug. I then went to Actos and got equally good results except for water retention problems. I did begin to have kidney problems (NO connection with these drugs) and my doctor wanted me to drop Actos due to the edema I was experiencing.

    I’ve not yet found a replacement for these two drugs and may possibly need insulin. I have increased my exercise and have hopes that will tame my steadily rising blood sugar levels. So far the exercise is working with the exception of very high fasting glucose readings. After that my sugars show steady decline throughout the day.

    Posted by Gayle |
  16. Avandia did definitely increase my Lipids and trigycerides. I was on it for about 4-5 years and went off it when I could not take the high doses of statins. Cholesterol levels went down to normal. Now I have heart problems!

    Posted by I.Banerjee |
  17. I took Avandia several years ago. Within 48 hours I just wanted to put my head down on the kitchen table and not move. I did not have a specific area that hurt. I just felt terrible all over. My husband took one look and me and said not to take another pill. I stopped immediately and never had that sensation again. I know it was the Avandia.

    Posted by Gail |
  18. I was taking Actos the cousin of Avandia. While they claim it doesn’t have the same bad effect as Avandia, I had weight gain as Francine did above, and it got to the point I had trouble breathing…like someone was stepping on my chest. I took myself off of it, and the negative symptoms disappeared within a week or less. I’ll never take Actos or Avandia again!

    Chris

    Posted by Chris |
  19. I was started on Advanda and it was keeping my sugar right, then my legs started swelling and I was having trouble breathing, when I could not walk out the house to my car, without stopping to breath, I told the doctor to give me something else, and I was having a lot of problems on Advanda.I don’t know if it done any damage, but I could not take it.

    Posted by Elaine |
  20. I took Avandia for a long time. When the first “study” came out, I asked my Dr. about it and we decided to go to Actos. I took Actos for over a year and then my blood sugars started to rise - over 300 over the course of a couple of months. I tried adjusting my other meds and adjusting my diet but nothing worked. We were to the point of considering insulin when I said to myself: “Back Up!. Why not try Avandia again?” I went back on Avandia and within two weeks I was back to normal. I have no problems with weight gain, cholesterol, high blood pressure - nothing. My HbA1c are typically 5.6 to 6.0. I am scared to death they will take it off the market and I won’t have anything as effective to help me control my blood glucose levels. I understand others may have issues, but medicines are not one-size-fits-all. Each person needs to determine what is right for them with the help of their doctors and nutritionists and pharmacists. For me, it is a gift of life.

    Posted by Janet |
  21. I was on Avandia for about 3 years, but my doctor took me off of it about 5 years ago and substituted another drug. My sugar has been very good for sometime. But I suffered kidney damage during the period that I was taking Avandia. My specialist is monitoring me very closely. Believe it or not, lawyers have contacted me wanting me to join a class action law suit against the manufacturer. My kidney’s are at 40% functional but holding at that level. Both of my doctors feel it was Avandia……

    Posted by Bill |
  22. I heard that taking Avidia is bad for your heart.You have more chance of having strokes and heart attacks when you take this drug and less chance of overcoming it.

    Posted by Eva Walker |
  23. We all run risks taking so much medicine as Type II diabetics; it come with the territory
    If you are experiencing problems, get off the med. Talk to the Doc.

    I’ve been taking Avandia for 5 years and have no problems, good arteries, and a strong heart.

    Posted by chef mike |
  24. I applaud the efforts of Sen Grassley and Sen Baucus to look into the problems with Avandia and Actos. I have a real hard time with the FDA approving a drug and then, when serious side effects crop up they do nothing but add a black box stating the side effects. I think it unconscionable that a drug is not promptly pulled from the market when fatalities result from an FDA approved drug. FDA is supposed to be looking out for the citizens of the USA. Perhaps the practice of the Drug Industry funding FDA research should end. It seems to create a conflict of interest that leaves the taxpayer out in the cold to fend for ourselves. Is that how the FDA ban on HFCS got reversed with the result of a vastly overweight problem among Americans, kids and adults alike?

    Posted by Shirley J. Hurry |
  25. Can anyone answer my question. I am taking Advandiamet. twice a day, I am type 2 will this be safer or worse. can someone answer this questioon for me has anyone taken this medication?

    Posted by Georgina |
  26. I started taking it in May 04 in Oct 04 I had my first heart attack !!!

    Posted by Dan Reid |
  27. A couple of years ago, I was placed on Avandia. It gave me excellent glucose control; however, I had increasing episodes of edema in my legs and feet. I was then placed on Actos with the same results. I have been having good results with Januvia. I also have been taking other oraql medications with ne ill affects.

    Posted by Lucille A. Herzegovitch |
  28. I have been on Avandia for 8 years, 2 mg to start and now 4, I still have highs and lows) Low meaning 134 and high’s 180, The only problem I’ve had so far is my legs hurt, not swelling, but jut hurt. I have Atrial Fiberlation, but my Dr. says Avandia is like all the rest, they all have side affects, and for me to stay on it.
    Dee Cox
    Florida

    Posted by Dee Cox |
  29. i have been taking avandia for about 15years and havent had any problems great testings my sugars are great iget a stress once a year no problems

    Posted by shirley fry |
  30. I was on Avandia for about 2 years until I had an unextected heart attack a month after a heart checkout (no new problems deteted) and required 2 stents. Avandia was immediately discontinued and started Januvia with far less control of diabetes II. At 73 I will not risk going back to Avandia.
    Ron

    Posted by Ron Garrett |
  31. I was on actos for a number of years. It caused lower leg swelling and sweating.

    Got drug out last may 2010 and at same time discovered monster dawn effect that was overloading body with glucose. Since solving issue, actos out, sugar control vastly improved. eyes and legs healing nicely.

    Jim Snell

    Posted by jim snell |
  32. I have been taking Advandia since 1998 when I found out I was allergic to glucophage. My current A1C is 5.4. I started out in 1998 at 7 something. I also take Byetta for about 2 years which I really do believe helps big time to keep the A1C at normal also. I go to see my doctor every three months. She listens to my heart and also takes an EKG I think every six months. She says I am doing great and she wants me to stay on Advandia. I am in a dilemma as to what to do. I trust my physician to the max! I do could not even imagine she would send me in the wrong direction.

    Posted by Geri Snyder |
  33. I have been taking Advandia for 4 years and have not had any side effects or problems. It is the only medicine I can take that helps me with my sugar. I have a reaction with other medicines that are like Advandia. It mamy not be for everyone NO medicine is but this has helped me and I wish they would bring it back.

    Posted by Shirley McKee |
  34. I hear you BUT:

    I was on Actos( nee avandia) and found my body filling up with water and my kidneys failing.

    At the time, my bg would not go sub 185 and wakeup
    was 238 and a1c was 13.3.

    My kidney Doctor wanted me off the actos (same as avandia)

    I started walking-exercising and found after walking 2 hours in morning; I could get blood glucose sub 140.

    Later checking, I found my liver hammering me on Dawn effect hammering up my body each and every morning.

    Eventually, found that metformin in sufficient dose size and timing shut dowm dawn effect and then I was on road to getting BG and a1c under control - initially 6.9 and now 6.4 and bg hovering around 140’s average.

    Even better, dropped the dam actos, dropped the 75/25 insulin 26 units and the starlix(previously was glyburide) and now 4 units of hunalog lispro regular at breakfast , 2 units at lunch and 2 units at dinner.

    Kidneys stabalized and efficiency now going up, weight now dropping, hemorages on eyes cleaned up.

    Diet was 1200 calories per day before stopping liver dawn effect 2 years and still as is after stopping liver 2 tears back. During bad phase could not lose any weight as it climbed to 330 lbs.

    2 years after liver stopped on dawn effect now sub 260 lbs and dropping.

    One other trick my doctor had me do was monitor BG and not let it drop sub 100. My liver whenever tasked to add glucose sub 70 emergency add was always dumping full or most of liver to shoot up BG to 511 and slip back to 278.

    By managing diet ans sufficient carbs so liver’s fifo buffer not tapped to do what it should do normally, it stops my BG being larded up with glucose.

    Not stated but a national disgrace is that sufficient exercise is needed to keep liquid energy burnt off.

    If you are working pharoh’s tombs to move 2 ton stone blocks by hand, no sweat eat up on the worlds best carbs and if you want to save your body - manage carbs caefully and ensure energy balance.

    Sitting, thinking, breathing burns very little. Only hearty exercise can keep the skeletal muscle cells from topping - off - saturating and blocking your own insulin - insulin resistance.

    The current folks promoting cures and describing how body works are unfortunately standing in wrong dead end tunnel with lights turned off.

    Insulin only causes glucose to be shifted from blood stream to available storage sites of liver, skeletal muscle cells and fat ceels THAT are not saturated AND have more spare room to store more glucose on insulin command. Otherwise Glucose backs up and shoots the blood BG up - no longer regulating.

    Contrary to the press, the human body is not an infinite motion infinte place to keep storing ever amounts of glucose to regulate body BG without saturating.

    I am unclear where that stupid idea came from which suggests it is - only add more and more insulin. If we could keep doing that somehow we would overcome insulin resistance. I believe you end up dead with a rotted out body.

    That does not burn the crap off - only process/hearty exercise do that.

    One real important FACT: each time my blood glucose was too high; I would walk 1/2 mile walking loops to burn out excess glucose and did so whenever I got spurious liver dumps whacking my blood glucose vertical - skywards. That ALWAYS got it back down.

    Posted by jim snell |

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