Jump to content

Photo

Latest Avandia News

- - - - -

  • Please log in to reply
12 replies to this topic

#1
netsavy006

netsavy006

    Junior Member

  • 500 plus
  • PipPipPip
  • 80 posts
From what I've heard on the news Avandia is under FDA review at this time because of the recent reports of heart attacks and stroke in older patients.

What's your thought on the drug?

Should it be pulled or is there still a small but slight use for this drug?
- Andy -
Dx: Asperger's + Schizoaffective Disorder - Bipolar Type + Panic Disorder w/o Agoraphobia
Rx: Lithium 900mg + Xanax 0.5mg TID + Celexa 10mg + Clozaril 325mg + Centrum + Fish Oil

#2
Rekarb

Rekarb

    Senior Member

  • 500 plus
  • 652 posts
Most of the science I've seen on Avandia seems fudged. I really question the usefulness of it. Once you throw in its potential harm, I think it should be taken off the market.
Dx'd 6/04/09 at dx -C - peptide > 1.5, GAD - Negative, BMI - 22, A1C - 9.9, FBS - 300

A1c 9/09 - 5.8, 12/16 -5.2, 3/18 - 5.6, 7/10 - 4.7
Was on Met and Insulin, now just diet (LC/HF)
Ketosis-Prone T2: http://www.annals.or...tract/144/5/350
Sudden onset T2 blog: http://ketosisprone.blogspot.com/

#3
foxl

foxl

    Senior Member

  • 500 plus
  • 13,756 posts
I do not know if anyone feels it is the only thing that would work for them ... I just know I would not take it.

I went off Actos, in fact.
Linda


[B]Jan A1c 6.3/B]
Jul 09 ... C-pep 1.3, GAD-65 > 30
Mar 10 C-pep 2.8 (20 g carb); GAD 3.2
dx 02/09 in DKA


Levemir 12U per day; novolog PRN TDD ca 16U
MetforminXR 1000 mg BID
Ramipril 5 mg
T4 112 mcg
Chia oil
Vitamin D3, 4000 IU
Eating 20 - 45 g carb per day ovo-lacto-vegetarian
Walking 30 min 6x week

#4
don1942

don1942

    Senior Member

  • 500 plus
  • 580 posts
It could be a similar situation that oxycondone went through. It increases the risk of heart attack for some, but at the same time, it could be the best solution, despite the risk. for many others. Time will tell. However, it seems GSK withheld the negative test results and as a result, jeopardized the health of many unsuspecting users. Perhaps it should not be withdrawn completely, but made available to those who would benefit from the medication after careful consultation (weighing risk verses reward) with their prescribing doctor.
Diag T2 1993
Started Minimed 03/12/10 CGMS 4/29/10
Symlin as needed
Metformin 1000mg x 2
Pravastatin 40mg x 1
Zetia 10mg x 1
Vitamin B, C, D, E, Fish Oil

#5
jfraga

jfraga

    Junior Member

  • Members
  • Pip
  • 6 posts
I currently take 4mg twice daily, my A1c is down from the 9's to 6.9, what other choices would i have? januvia doesnt work for me anymore, sulfonureas make me bottom out when i exercise. I have a pretty serious family history of heart disease. I might have to go with the sulfonurea but may skip on running days or even thought about just getting me a sliding scale insulin along with my metformin,
3/4/10 - hga1c - 9.9

#6
killerleaf

killerleaf

    Senior Member

  • 500 plus
  • 542 posts
my take on this whole thing, based on what I have read:

diabetes automatically increases our chances of heart attacks and/or strokes.
old age automatically increases our chances of heart attacks and strokes.
avandia was given to older, sicker patients, who, it would seem, would be at higher risk for heart attacks and strokes to begin with.
what is the actual rate of heart attacks in younger, healther patients??
beware, for beyond there be dragons
Lantus 48 units twice a day
Latest A1C 7.1

#7
ShottleBop

ShottleBop

    Senior Member

  • 500 plus
  • 6,634 posts
Gretchen Becker has a good discussion of the newest Avandia studies over at Wildly Fluctuating. Her conclusion is that it is simply not clear.

So is rosiglitazone safe to take? The evidence is not clear-cut. The FDA will soon meet to discuss the safety issue, presumably taking into account other studies in addition to the three discussed here.

But these three studies are a good example of the slippery slope we have to deal with when results of large clinical trials are published: confused statistics, biased authors with ties to drug companies, and different patient groups, comparisons, and end points.

I wonder how many bad drugs are on the market because of confusing clinical studies. So too, I wonder how many good drugs might have been dropped from the pipeline because of equally confusing clinical studies.

Evaluating risks vs benefits is not simple, and the best choice for a large population is not always the best choice for an individual patient. You might be allergic to a drug that helps most patients. Conversely, a drug that harms most patients might be wonderful for you.

All this is one reason that controlling with good food and exercise should always be the first choice. But this isn't always enough. Then we and our physicians have to evaluate which drugs will work best for us.

It is not a simple task.


Functionally, a Type 2 (missed the label by th-a-a-a-a-t much)
Dx prediabetic 02/08 (FBG 127 and 123), A1c 6.5
So far, controlled without meds.

#8
art

art

    Senior Member

  • 500 plus
  • 2,028 posts
  • LocationWest Coast Florida
  • I am a:Type 2
Given what has been written what doctor in his/her right mind would prescribe it?

It's a malpractice suit waiting to happen.

Art

#9
genie86333

genie86333

    Senior Member

  • 500 plus
  • 2,191 posts

Given what has been written what doctor in his/her right mind would prescribe it?

It's a malpractice suit waiting to happen.

Art


My doc believes the drug reps who have shown her the studies that show that the original study was blown out of proportion. She said that the original study said that there's a 50% increase in risk of strokes, which does sound horrible...but then when it's brought out that on the placebo, only a very TINY # (.5%) of them had strokes, that means a 50% increase is only a quarter of a percent!

Now, my family has a history of strokes...plus I have had macular edema which is *another* contra-indication for Avandia, so I refused to take it, but she does prescribe it regularly.

#10
ShottleBop

ShottleBop

    Senior Member

  • 500 plus
  • 6,634 posts
From CNN.com, this afternoon:

Washington (CNN) -- A Food and Drug Administration committee delivered a split verdict on the diabetes drug Avandia on Wednesday, with most members voting to leave it on the market but recommending changes in how it's prescribed.

Twelve of the committee's 33 members voted to pull Avandia off the market altogether, while only three supported leaving it on the market with its current labeling. Seven wanted to add stiffer language to the current label, and 10 wanted both stiffer language and restrictions on its use.

The vote came on the second day of hearings into the safety of the drug, which studies since 2007 have linked to an increased risk of heart failure. One member abstained, and several said their votes easily could have gone another way.

"I think the evidence of potential harm is stronger now than it was in 2007," said Dr. Peter Savage, the director of the National Institutes of Health's epidemiology division, who voted for stronger warnings and restrictions. "I think if the drug is to remain on the market, we need to consider whether there would be some specific indications in which it would be reserved for use. It seems to me that simply putting a warning, a black-box warning, in the labeling is probably not sufficient to really protect patients."

Avandia manufacturer GlaxoSmithKline has insisted on the safety of the medication, which is used to control blood sugar levels in diabetics. But a company-sponsored study that Glaxo said showed there was no higher risk of heart problems came under heavy fire from FDA researchers during proceedings Tuesday and Wednesday.

Before the votes, Chuck Keyserling, who suffers from type 2 diabetes, told the panel he has been taking Avandia for 10 years and can't take an alternative drug because of his physical limits on exercise.

"In making this plea to keep Avandia on the market, I believe I am pleading for my life," Keyserling said. For people in his position, "a negative position on Avandia may be a death sentence."

In two preliminary votes, the advisory panel found that Avandia has an increased risk of heart problems compared with other drugs -- but it made the same determination in 2007 without voting to pull the drug, recommending stronger warnings instead. The committee would not conclude the drug poses an increased risk of death, with most calling the data before them insufficient.

"Until we have a longer-term follow-up we just can't say much about mortality," said committee member Dale Hammerschmidt, a University of Minnesota medical professor.

A strongly worded FDA report last week called Glaxo's RECORD study, which the company cites as evidence of the drug's safety, "inappropriate and biased." It accused Glaxo of repeatedly submitting sloppy data and failing to follow up on reports of problems among patients, including deaths.

And Dr. David Graham, the author of a June study that also found higher risk of heart problems among Avandia users, said the RECORD study would have been dismissed as "garbage" if it had been used to seek the drug's original approval.

But Dr. Murray Stewart, Glaxo's vice president for clinical development, said Tuesday that the company's studies "provide the most robust and reliable data" to assess Avandia's safety -- and those studies have found "no evidence to suggest" the drug increases the risk of heart problems. Stewart defended the RECORD study again Wednesday.

Glaxo says several trials have shown Avandia is safe, but its usage has fallen sharply since a 2007 study that linked it to an increased risk of heart attacks and other related problems. Published estimates indicate annual sales of Avandia have dropped from about $3 billion in 2006 to about $1 billion.

A Senate committee added to the controversy Tuesday. Its leaders released documents they said show Glaxo "failed to publish studies that found serious health risks associated with Avandia in a timely manner and actively promoted the drug despite the known safety concerns."

The documents, which the Senate Finance Committee provided to the FDA, include studies that date back to 2000, the committee's Democratic chairman and ranking Republican said. But in an e-mail, Glaxo spokeswoman Mary Anne Rhyne told CNN the new documents were "a small subset" of millions of pages the company released in connection with lawsuits over the drugs.

"They include drafts and other documents taken out of context, which therefore are incomplete and misleading," Rhyne said. "The documents do not offer new clinically relevant scientific information, and do not provide the full extent of GSK's studies and evaluation of Avandia."


Functionally, a Type 2 (missed the label by th-a-a-a-a-t much)
Dx prediabetic 02/08 (FBG 127 and 123), A1c 6.5
So far, controlled without meds.

#11
ICDogg

ICDogg

    Junior Member

  • 500 plus
  • PipPip
  • 22 posts
I still take Avandia. Well, technically, I take a generic version that I order from a Canadian pharmacy that is then shipped from New Zealand but is made in India. Which is very strange but I get 100 8mg tabs of "Senzia-8" for less than $100 shipped, which is almost as cheap as if I had a prescription plan, which I don't.

I haven't tried the Actos, but I will say, I tried to get away without taking Avandia for awhile and for me it was a disaster. I had to increase dosages of insulin and other meds to make up the difference. It wasn't good at all. The Avandia works, it works well, and that's why I still take it. (As I said, Actos may be just as good buy I haven't tried that).

#12
Richard157

Richard157

    Senior Member

  • 500 plus
  • 1,407 posts
I am type 1, but I was dx with insulin resistance in 1998. I started taking Avandia in 1999 (4 mg, twice daily). It has been a wonderful drug for me. I was able to reduce my daily insulin dosage 40%, which resulted in much weight loss (it was weight gain in the mid 1990's that caused my insulin resistance). I have taken Avandia for 11 years. I am 70 years old, and my heart is strong and healthy. I am only 8 pounds overweight now.

My doctor took me off Avandia in May, 2007, when all these reports started coming out. I used Actos for 6 weeks and ran a lot of high blood sugar. I resumed taking Avandia and my blood sugar was normal again in only a few days.
Type 1 for 68 years, A1c = 6.1, pump with MM 523 Revel, I have good health.

You never know how Strong you are until being strong is the ONLY choice you have!

#13
ICDogg

ICDogg

    Junior Member

  • 500 plus
  • PipPip
  • 22 posts
Richard,

Do you feel there is an advantage to taking 4mg of Avandia twice per day as opposed to 8mg once per day?




0 user(s) are reading this topic

0 members, 0 guests, 0 anonymous users