Posted on 06/05/2008 9:43:12 PM PDT by neverdem
The Food and Drug Administration said Wednesday that it was investigating whether four drugs used to treat rheumatoid arthritis and other immune system diseases might increase the risk of cancer in children.
The F.D.A. said that it had received reports of 30 cases of cancer over 10 years among children and young adults treated with those drugs, which are sold by Amgen, Abbott Laboratories and other companies.
But the agency did not make clear how many children had taken the drugs or whether the cancer incidence among them was higher than would be expected. And it said that for now, it believed that the potential benefits of the medicines outweighed the potential risks “in certain children and young adults.”
The drugs involved are Enbrel, sold by Amgen and Wyeth; Remicade, sold by Johnson & Johnson and, in Europe, by Schering-Plough; Humira, sold by Abbott Laboratories; and Cimzia, which won approval in April and is sold by UBC, a Belgian company.
All the drugs try to damp inflammation by blocking a protein called tumor necrosis factor, and they are used to treat various immune diseases including rheumatoid arthritis, psoriasis and Crohn’s disease, which is an inflammation of the bowel.
The TNF-blockers, as they are known, represent one of the most successful classes of drugs ever developed using biotechnology. Remicade, Humira and Enbrel had combined sales of more than $13 billion last year.
But use in children constitutes a small part of the total. Dr. Michael Severino, an Amgen executive, said about a half-million patients had been treated with Enbrel since its approval about a decade ago, of which only 12,000 were children.
Remicade is approved to treat Crohn’s disease in children. Enbrel and Humira are approved to treat juvenile idiopathic arthritis, once known as juvenile rheumatoid arthritis...
(Excerpt) Read more at nytimes.com ...
Anyone want to bet the FDA will ban these drugs for use by everyone including the elderly?
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I doubt it. Celebrex is still on the market. They don't have better alternatives. Warnings will increase; that's all.
Vioxx is still off the market. It's removal from the market pushed my mother to get a knee replacement. She kept a stash of Vioxx for times when nothing else would work.
I still have about 30 Vioxx. I can't take any of those drugs mentioned in this article for my RA ... they're contra-indicated if you also have MS ... lucky me. However, I like that article today about drinking lots of alcohol to stave off RA ... I should have had more to drink when I was younger!
what the article doesn’t mention is that certain cancers are more common in those with Rheumatoid arthritis...
The real question is if the medicine merely increases this risk a little, not if it causes cancer.
As for banning: If given the choice of a small chance of death versus being in a wheelchair and with every joint in your body hurting, I’d chose the cancer...
yeah, I read about their claim if you drank alcohol you got less Rheumatoid arthritis.
But you know, I worked in the Indian Health Service, and Rheumatoid arthritis and other collegen diseases were common They thought it was a genetic cause...indeed, we had one family where half the family had one disease or another...when the uncle got sick and we couldn’t figure out why, I sent him to the Rheumatologist and mentioned he belonged to the C.... clan...and sure enough, he had lupus...
“Anyone want to bet the FDA will ban these drugs for use by everyone including the elderly?”
I don’t think they will. Honestly, I’d be very surprised if these drugs didn’t increase the risk of getting cancer. They shut down the body’s inflammatory reactions, and with a slightly less attuned immune system, cancer is just all that more likely.
That said, these drugs work wonders, and not just with people who have Rheumatoid arthritis. Remicaid (or infliximab, generically) and these anti-TNF monoclonal anitbodies are essentially the only drugs out there that work for some of these people with an acute phase Crohn’s disease or ulcerative colitis. And they can’t stay on steroids their whole life.
My guess is that unless the rate of cancer is off the charts, these drugs stay around. You’ll just see extra warnings and heightened surveilance. These drugs are too invaluable to just remove from the market.
Again, I think the medical community pretty much expected the risk of cancer. It’s just a question to what degree.
I tried Remacaid, and had 4 treatments, but still wasn't able to come completely off of prednisone to control my Crohns disease. We've pretty much given up, and I've just decided that I'm just going to have to stay on 20mg of prednisone for the rest of my life... It's been 22 years so far, and nothing else has been able to control the flare-ups.
Mark
My prayers are with you.
I’m very lucky, in that the prednisone controls my symptoms well, and I haven’t had a major flareup in nearly 20 years until just recently, but boosting my predinsone took care of it. Like I said, I’m lucky - or blessed - because there are people who really suffer from their IBD. I can function reasonably well every day.
Good luck with your UC. It sounds like you’ve got far more problems that I. My prayers are with you.
Mark
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