Posted on 02/19/2010 9:49:49 PM PST by neverdem
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.
The reports, obtained by The New York Times, say that if every diabetic now taking Avandia were instead given a similar pill named Actos, about 500 heart attacks and 300 cases of heart failure would be averted every month because Avandia can hurt the heart. Avandia, intended to treat Type 2 diabetes, is known as rosiglitazone and was linked to 304 deaths during the third quarter of 2009.
“Rosiglitazone should be removed from the market,” one report, by Dr. David Graham and Dr...
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These concerns, in internal reports dated October 2008 but not made public until now, were later overruled by other agency officials, and GlaxoSmithKline is currently enrolling patients in the TIDE trial. The trial is not expected to be completed until 2020, although the company is hoping to report some results to the F.D.A. by 2014. The company’s patent on Avandia expires in 2012, and generic versions will probably swallow most remaining profits.
In a letter sent Thursday to Dr. Hamburg, the Food and Drug Administration commissioner, Mr. Baucus and Mr. Grassley asked “what steps the F.D.A. has taken to protect patients in the TIDE trial” and said the trial’s patients had never been told about the concerns raised by the agency’s own safety officers...
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So company executives gathered dozens of Avandia studies and sifted their combined data. Called a meta-analysis, this combined look found first in 2005 and in an updated look in 2006 that Avandia increased the risks of serious heart problems by nearly a third, the Senate investigation shows. Because two-thirds of diabetics die of heart problems, this was hugely worrying...
(Excerpt) Read more at nytimes.com ...
And it was my favorite dish at the Italian restaurant, too. Bummer.
I’m so glad the FDA is after Kevin Trudeau......
This is making me glad that I haven’t been able to afford to refill my prescription!
High levels of vitamin D in older people can reduce heart disease and diabetes
FReepmail me if you want on or off the diabetes ping list.
“. . .carbonara?”
Isn’t that the bad word Jennifer Lopez and George Lopez called Mrs. Palin?
Finally! About 5 years ago I took Avandia for 4 or 5 months and got progressively sicker each day. Swelling, muscle aches, fatigue, palpitations, etc. Tried to tell my doctor, but he didn’t think it could be the med. I even emailed the FDA, etc. about it, but never received a reply. Finally stopped taking it myself and was soon back to normal. Terrible drug for Type 2 diabetes
Why did it take you so long to put it down? It reminds me of my father, he had to give up working as a carpenter and go on disability while in his mid fifties. The doctors said he had severe arthritis and would not live long, they put him on a medicine that he only took for a few days and then threw the rest away. He said that stuff will kill you. A few years later the medicine was taken off the market because the stuff would kill you. I can’t remember the name of it but Dad lived to be one month shy of eighty two and was completely free of arthritis symptoms in his later years. In fact in his late seventies he was as flexible as a thirteen year old. He did a lot of work on his own house long after the doctors who told him he wouldn’t live long had been buried.
Sometimes you have to listen to your own body and ignore the doctors.
I took it briefly as well but immediately stopped when I heard the reports. And yes, they put me on Actos.
Best decision I ever made.
ping
Just my two pennies.
Ping for later.
Ping
This must have been approved by the FDA before it was marketed.
What do they mean, it’s not safe?!?!?
That wouldn’t have been Vioxx would it?
Thanks. Adult onset diabetes can be helped in many ways.
There were warnings about ACTOS as well. I was taking it and when I saw the warnings I asked my doctor (had switched doctors at Kaiser because the prior one moved away). I already had 1 heart attack (mild) and 2 stents put in heart as result. He told me that he wouldn’t have prescribed it with my history based upon what they knew now. I had him take me off of it and we did something else.
Those are incredible statistics, and it would be remarkable if they didn't show up during the various trial stage. Or if they did, it's damning that they were not reported.
This is a very serious failure of the system.
“That wouldn’t have been Vioxx would it?”
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This happened before Vioxx came along, whatever it was my father took it for a very short time and decided his body was telling him to stop it before he died from it. My mother was a nurse and she was very upset when he wouldn’t take the stuff but when it was pulled off the market and my father started into full remission without medication she had to rethink.
He never knew what to credit his recovery to but he figured it was some kind of wild plant he had eaten. He said he had eaten raw every wild plant that he thought wouldn’t kill him and something must have worked. He had a fair knowledge of plant life gleaned from practical experience on the farm, not from school.
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