What is Fibromyalgia

Fibromyalgia (FM or FMS or Fibro) is a debilitating chronic syndrome (constellation of signs and symptoms) characterized by diffuse or specific muscle, joint, or bone pain, fatigue...

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Discussion:
Lryica cancer study
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This is a prime example of how the FDA is protecting us…….are you a mouse or a rat?
What the hell I did not see this information in the patient information packet.

Carcinogenicity Studies
The carcinogenic potential of pregabalin was evaluated with 2-year toxicology studies in rats and mice. Results showed no evidence of carcinogenic activity in rats. However, there was evidence of carcinogenic activity of pregabalin in two strains of mice based on demonstration of significant increases in incidences of hemangiosarcoma at several anatomical sites. Additional studies in mice showed that the initiating event for hemangiosarcoma occurred early following exposure (in the first year of exposure) and in the second year of exposure there seemed to be an accelerated rate of tumour development as evidenced by the higher rate in the continuously exposed mice.
The sponsor has conducted numerous additional studies with pregabalin to elaborate the possible mechanism of action in the causation of malignancy found in mice, but none of the studies have provided clear evidence for possible mode of action of the drug. It should be noted that pregabalin has no genotoxic activity, thus its mode of carcinogenic action is assumed to be epigenetic. In summary, because of the positive carcinogenic findings in mice, the carcinogenic potential of pregabalin for humans remains a matter of concern. However, since the carcinogenic activity of pregabalin has been demonstrated only in one species (mice) at relatively high systemic exposures (based on blood level comparison of pharmacokinetic parameters with those of humans) and not in a second species (rats), the potential carcinogenic risk of pregabalin exposure in humans is considered to be small
Posted on 12/31/07, 06:19 am
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Reply #1 - 12/31/07  7:16am
" My husbands first cousin is a doctor he works for one of the major drug companies, he developes and researches new drugs. He was here in Michigan in Nov. and I asked him about Lyrica, he said basically from what he has seen and read the possibilities of Lyrica being a carcinogenic is small, but it is early in the research and because the drug is still relatively new no long term studies have been done. I am a little concerned about taking it because we really have no real idea of what the effects are yet. "
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Reply #2 - 12/31/07  7:35am
" I was under the impression that FDA approval meant somthing. "
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Reply #3 - 12/31/07  7:37am
" My brain is too sozzled to make sense of that sorry :( does that mean its been linked to causing cancer? "
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Reply #4 - 12/31/07  7:49am
" I worked at the EPA a long time ago. Then my work involved me in some aspects of FDA approval.

I think at this stage, I really don't want any new drugs. I will wait until they have been out there for a while. Testing on an Ld50 basis leaves me uncomfortable. As does testing that shows potential carcinogenic activity. I am afraid that I fear that profit plays too big a role in how the drugs make it to the market. CFS and Fibro are finally making some waves as we become "real" instead of imagined. That is an awful big base of chronically ill people waiting for relief.

Cynic, yep. "
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Reply #5 - 12/31/07  7:53am
" i understand that the risk is low but when you see the research (you can see the FDA approval information at FDA.org) and then you see stuff like the artical below its rather upseting.


Published: September 7, 2002
Pfizer will delay seeking approval in the United States for an epilepsy treatment called pregabalin until next year because it wants to include more safety studies in its application. The company expects to apply in March for approval of pregabalin in Europe and then in the United States, Pfizer said. Pregabalin is a successor to Pfizer's Neurontin, which had about $1.75 billion in sales in 2001. Pfizer may need pregabalin to help replace sales that could be lost to cheaper generic copies of Neurontin. Last year, the Food and Drug Administration asked Pfizer to withhold pregabalin from some patients after a study linked the drug to an increased incidence of tumors in mice. "
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Reply #6 - 12/31/07  9:25am
" Oh lovely. Thanks for the info. I have yet to look into Lyrica and what it is made of or even what type of drug it is. I thought it was a sister drug to Neurontin?

I am into my second week on it. The yuckies went away but so far nothing as far as relief. I am on 300 mgs a day but the pharmacist said I may have to go up to 1,200 mgs! I was like that is an awful lot of it!

Don't get me going on the drug companies lobbying to push medication through before it has clinical trials and is known to work and be safe.

I hope it doesn't give me cancer... "
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Reply #7 - 12/31/07  12:14pm
" I hope that it doesn't cause cancer, this is the only med that has made a dent on my pain. I don't want to stop. "
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Reply #8 - 12/31/07  12:26pm
" the thing about anything, if you are exposed to to much, we can get cancer...even our life giveing Sun can cause cancer, yet we NEED it to survive...it is all a delicate balance...pros and cons hafta be weighed out...there is not a medacine out there that does not come with side effects...and risks...you have to decide if those side effects and risks are worth it to you...any meds you are on you need to research, cause most dr.s will not mention all the risks...I even had one dr. lie straight to my face on the risks and side effects...and so when I had an effect i was Not expecting I thought i was haveing some kind of allergic reaction...here it is a COMMON side effect...lol...crazy !
anything I am givin, I jump online...go straight to THEIR website...print out all the info and read it...makeing my own decisions for myself...most I disregard because I have either grown sensative to that TYPE of med...or the effects are simply not worth it to me. "
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Reply #9 - 12/31/07  1:31pm
" DARN IT! The only other drug that has worked this well for me was vioxx, and they took it off the market. I did find out that if I take it the 3 times/day like the doc told me to, I get sick and kinda strange feeling. That is only at 75mgs each time. I take it now only 1 or 2 times a day. That seems to keep the pain semi-bearable, so I am hoping and praying that they decide it doesn't give cancer to us humans! "
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Reply #10 - 12/31/07  5:23pm
" LET ME SHARE WITH YOU HOW MUCH THEY WANT TO PUSH IT.
I HAVE A FRIEND HOW HAS BEEN ON A PAIN PUMP FOR 2 YEARS WITH NO PAIN AND HER DOC TOLD HER TO TYR LYRICA TO SEE HOW IT WORKED ON HER, TELL ME THAT HE IS KIDDING, NOPE, HE PUT HER ON LYRICA EVEN THO SHE WAS IN NO PAIN. SHE FINALLY TOOK HERSELF OFF AFTER 2 MONTHS OF BEING ON IT....SHE FINALLY FIGURED OUT THAT IT WASN'T HELPING HER....CAN YOU BELIEVE THIS CRAP.....LOVE....HELEN "

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