The Food and Drug Administration (FDA) sometimes calls on an advisory committee to help them decide a course of action when issues with medications, products, food or other regulatory items arise. This is what happened on July 30th, in Virginia. The Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee met to hear presentations of data on rosiglitazone (Avandia) from both the FDA and GlaxoSmithKline (GSK), the company that manufactures Avandia.
- FDA Presentation of Data Regarding Risks of Rosiglitazone
- GSK Presentation of Data Regarding Risks of Rosiglitazone
After weighing the facts presented to them, the committee members voted by an overwhelming margin, to keep Avandia on the market, despite some evidence that the drug may cause instances of increased cardiac fatalities. The FDA does not have to abide by the decision of the advisory committee, so the fate of Avandia still does hang in the balance until the FDA makes a formal decision.
Should Avandia be pulled or should it continue to be available as a medication option for controlling type 2 diabetes?
Science says it’s a bad drug, they voted overwhelming on that issue, this help with “See I do know what’s good and bad after all I am a doctor.” However, money gives them a second vote to distance them self from the truth. Track down one of the major contribution to American Diabetes Association, I did, GlaxoSmithKine is right there in the top.
Pull it off the market. Diabetics have a tough enough time with “complications” without the drugs they take adding to the problem. It’s too bad this newsletter and everyone else involved in this issue don’t spend more time educating diabetics in the use of insulin and also set goals for A1C tests that would get rid of more of the complications. NONE of these pill-type drugs for diabetes allows true insulin management – they all interfere with other normal processes in the body. They are all one-size-fits-all and we all know that life (and the human body!) is not like that. But even docs and DNE’s seem to encourage people away from insulin – OOOoooh, there’s all those needles.
Well, if you get your A1C below 6.0 (like normal people) you don’t get all the damage (heart disease, kidney disease, eye disease, etc) and the ONLY way to do that is with injectable insulin.
Wake up people – it’s HUMAN INSULIN – the stuff your body makes normally!
Pull it from the market!! It has been shown to cause cardiac problems so obviously it’s NOT a healthy drug for diabetics to take. I agree with another responder who said diabetics have enough problems without adding yet another one.
I took Actos, the OTHER drug in this category, and I refused to take it after about 8 months because I started to have severe swelling of my legs and ankles, and a number of other problems…immediately, the swelling (fluid retention) went away when I stopped the Actos. A little over a year after stopping it, I needed an aortic valve replacement. Now, I’m not saying that Actos CAUSED IT, however, nobody can convince me otherwise that it didn’t have something to do with the problem that arose after I stopped taking Actos.
ACTOS is just as bad as Avandia! They should BOTH be pulled from the market!
Avandia has my vote in the Positive. I currently take Avandamet, a combination of Avandia and Metformin(Glucophage). Since I have been on this my A1c and FBG’s and Postprandial levels are significantly lower.
My Grandmother died from Kidney and Cardiac complications from Diabetes. She was on Insulin and other earlier Oral Hypoglycemics.
I am a retired Paramedic, so I do not jump on the Media Bandwagon, or jump to fast conclusions. I Actually read the NEJM Article that started this Media Frenzy. The Authors state there are flaws in their analysis, they were not privy to all the data, and they actually did not use all the available studies. Actually the Median A1c was 8.2%, that as we all know is high.. I have not seen that level for months to years. The Higher your A1c the more prone you are to have Cardiac and other complications. So if you are below 6.0% as noted; your risk of complications if significantly diminished. Since I have been on Avandamet My A1c’s have been below 5.4%. This to me is remarkable!!!
There are some complications from taking this drug, one of which is edema or fluid retention. This is well documented, as Avandia is the single most studied drug in U.S. history. If you develop this, or other edematous side effects you are supposed to discontinue use.
Read the Article; see the flaws for your self. Besides FDA Overwhemingly voted to keep Avandia, The science is there. http://content.nejm.org/cgi/content/full/NEJMoa072761
My Vote is for Avandia maybe I will not die of Kidney Failure, requiring 3 times a week dialysis, or the subsequent Congestive Heart Failure as my Grandmother did.