GlaxoSmithKline challenges NY Times article on Avandia report

Over the weekend, the NY Times published a story where it discussed:
"Hundreds of people taking Avandia, a controversial diabetes medicine, needlessly suffer heart attacks and heart failure each month, according to confidential government reports that recommend the drug be removed from the market."

We posted the news story here:
https://forum.tudiabetes.org/topics/avandia-harms-heart-us

Today, GlaxoSmithKline (the company that makes Avandia) issued a statement on its blog, where it challenges the NY Times story:
http://www.morethanmedicine.us.gsk.com/blog/2010/02/important-facts-about-avandia.html

Reading both sides of the story, what are your thoughts on Avandia and its safety as a drug for patients with type 2 diabetes?

I have seen some of the actual research on Avandia and it is very troubling when it comes to heart attacks and congestive heart failure. Just recently Dr. Nissan of The Clevland Clinic, one of the most respected heart research facilities in the world, reported serious problems caused by Avandia. (You can google the article) I believe there have been at least 2000 cases of people reporting heart failure while on Avandia. I would stay clear of Avandia and if on it ask my physician for a safer alternative like Actos.

Per my husband, who is in pharmacy school, apparently this is not new information. A few years ago, doctors/researchers were saying that Avandia wasn’t good but GSK would essentially cover it up and sorta threaten them to be quiet (pull funding, go to superiors, etc).

There is a black box warning on Avandia, so while it’s still being used out there, proceed with caution.

I think their boat is gaining water, and they are quickly trying to bail it out… A lot of these meds get fast tracked to approval, without really understanding the long term repercussions of what they are going to do to the human body… or with an understanding, but not much care, as money talks – and money has been the main drive of many other risky medications which the benefits have seriously NOT outweighed the side effects: anyone recall Fen-phen? The FDA had approved that medicine too, and lots of, otherwise, completely healthy people developed heart problems, and had heart attacks… all to lose a few pounds. The next medicine that seems to be risky is Yas-Yazmine-Yaz, for birth control… again with similar problems. A lot of these companies think that just by citing the ‘warnings and side effects’ they wash their hands clean… but if this is starting to happen to a lot of people, who otherwise do not have a family history of these issues (nor a personal history of heart troubles), I just doubt they will be able to keep this on the market for much longer… Vioxx wasn’t able to, and for the people who it worked, it was a miracle drug.

You are 100% correct! I think Avandia is is on its last leg. The law suits will be starting up soon if so many people have been hurt. The FDA has got to get tougher.

It isn’t just heart disease.
Diabetes Drugs Avandia, Actos Tied to Fractures in Women
That isn’t the only study showing this effect.
Heres another.
The Risk of Fractures Associated with Thiazolidinediones:

Jenny was onto the heart problem with these drugs years ago.

When Steven Nissen published this connection in 2007 (http://content.nejm.org/cgi/content/short/356/24/2457), he set off a firestorm. All drugs have side effects, that is why we use them, unfortunately sometimes those side effects can have bad consequences. What is difficult is making an appropriate decision on whether a drug should continue to be made availabe and what warnings are appropriate. Right now, Avandia prescribing information warns that certain populations of patients are at risk, and should not be given Avandia. If that is perfect in avoiding heart attacks and heart failure, then that would be just peachy keen, but we know that is not going to happen. The difficult question is how to make a tradeoff between helping patients lower their blood sugar (and avoiding complications like heart attacks) with the drug while at the same time exposing them to additional risk of heart attacks. If the risk of drug induced heart attacks is relatively small, you might still want to medication to be used for its benefits in avoiding heart attacks caused by elevated blood sugars.

Make these sorts of balanced decisions is difficult. I accept that no drug is totally safe, but I expect that the FDA should make decisions in the best interests of patients. Unfortunately it does not always do this.

Avandia is Killing Americans, FDA Negligence Comes Front and Center Byron J. Richards take on the FDA aspect of this story.

I don’t take it but the article in the paper was really scary. If you give it to a population that already has a higher risk of heart attack and heart failure the outcome can’t be good.

I’m a type 1 but I found this blog about avandia interesting. The writer has a PhD in Pharmacology and runs a medical research laboratory at the University of Colorado.

Here the link: http://asweetlife.org/robert/blogs/type-2-blogs/avandia-and-heart-disease-part-1/5111/

I hope this helps. I know this represents only one point of view and there are others who think otherwise.

Hello Judith! Your comment on the “D being progressive” is sad. I was inspired by Jenny Ruhl’s book “Blood Sugar 101”. I now believe that despite the progressive nature of D you can slow the heck out of any progression if you really get after it. I recommend it highly.

In my particular case I took avandia for 1 year at 10 mg and I cannot say that it did anything to the heart but also it did not do anything for the blood sugar. The only damage was the high BG and the pocket book. On diabetesdaily I read that Australia has banned it.

As usual, buyer beware. GlaxoSmithKline and the FDA should pay some kind of payout to the families. The Doctors who knew of the problems before this month’s news should lose their kickbacks from their prescriptions.