Latest Avandia News
Posted 13 July 2010 - 02:03 PM
What's your thought on the drug?
Should it be pulled or is there still a small but slight use for this drug?
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
Posted 13 July 2010 - 02:07 PM
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/
Posted 13 July 2010 - 02:08 PM
I went off Actos, in fact.
[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
Vitamin D3, 4000 IU
Eating 20 - 45 g carb per day ovo-lacto-vegetarian
Walking 30 min 6x week
Posted 13 July 2010 - 07:15 PM
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
Posted 13 July 2010 - 10:36 PM
Posted 14 July 2010 - 07:58 AM
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??
Lantus 48 units twice a day
Latest A1C 7.1
Posted 14 July 2010 - 08:12 AM
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.
Dx prediabetic 02/08 (FBG 127 and 123), A1c 6.5
So far, controlled without meds.
Posted 14 July 2010 - 02:16 PM
Given what has been written what doctor in his/her right mind would prescribe it?
It's a malpractice suit waiting to happen.
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.
Posted 14 July 2010 - 04:00 PM
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."
Dx prediabetic 02/08 (FBG 127 and 123), A1c 6.5
So far, controlled without meds.
Posted 09 August 2010 - 12:17 PM
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).
Posted 09 August 2010 - 06:16 PM
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.
You never know how Strong you are until being strong is the ONLY choice you have!
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