9/8/11 The U.S. Food and Drug Administration, or FDA, is warning that people who take tumor necrosis factor-alpha blockers, also known as anti-TNFs or TNF-blockers, may be at risk of infection from the bacteria Legionella and Listeria.
After reviewing cases of infection in patients treated with the drugs, the FDA is strengthening the drugs’ boxed warning labels to include the two bacteria.
Anti-TNFs, a type of biologic product, are used to treat rheumatoid arthritis, or RA, ankylosing spondylitis, psoriatic arthritis, juvenile arthritis and several other conditions. The new warnings will be added to labels for infliximab (Remicade), etanercept (Enbrel), adalimumab (Humira), certolizumab pegol (Cimzia), and golimumab (Simponi).
Serious infections – from bacteria, fungi, viruses, mycobacteria (including tuberculosis) and other opportunistic pathogens – are a known risk of anti-TNFs, which can compromise the immune system’s ability to fight infections. Patients older than 65 and those taking other immunosuppressive drugs may be at greater risk of infection.
The added warning may help patients with these infections get treatment more quickly, according to the FDA. In the past, healthcare professionals weren’t always aware of the risk of certain infections, leading to delayed treatment.
“Any product we use to treat rheumatoid arthritis, because it affects the immune system, always has the potential for infection,” says David Pisetsky, MD, PhD, chief of the division of rheumatology, allergy and clinical immunology at Duke University Medical Center. “The difference is there are now two other organisms that we have to be concerned about. So, if a patient gets sick, you add into your thinking, ‘Could it be Legionella or Listeria?’”
Jeffrey Curtis, MD, director of the Arthritis Clinical Intervention Program at the University of Alabama at Birmingham, agrees. “All the FDA has done is called out two specific infections among all the other ones that physicians have been thinking about,” he says.
“The take-home message for patients is that they should not have new concerns or worries about the safety of these medications,” says Dr. Curtis, who is also an associate professor of medicine at UAB and a former Arthritis Foundation-funded researcher.
Wishing everyone a a pain free hour today. It is very hard to find some meds that will work. Sometimes even harder to find a MD that will listen to you. After many drugs now taking Enbrel a most of the time it helps the RA. Most health care workers do not feel that FM is real, they feel that you are only looking to get a fix , so very sad that you must deal with this on top of the pain & weakness. And also hard to work in the health care field with people that I love , but refuse to see that some conditions are real no matter what they think.
i think that is the problem. Has anyone else had this kind of problem? Was it the Enbrel? What can I do about it? My psychiatrist is going to consult with my rheumatologist. I am so scared that something is wrong with my brain or that I have some sort of dementia.
I also tried the natural therapy route and went to an MD who did allergy testing. I was allergic to wheat and dairy. Well, that sums up most of the food I eat! I have been off wheat (eating gluten-free which some cheating here and there) and I have to say my symptoms had not been as painful nor as frequent. In addition, I lost 15 lbs with no effort.
I would love a combination of a rheumatologist who treats with medication AND vitamins, diet, etc. I'm not one to take medication and I'm concerned to read that many medications stop working after awhile, then it's on to a different or stronger one. It seems on one knows the answer.
When I can move, I teach and take Nia (www.nianow.com) classes, which is a wonderful healing dance that has helped me move and stay centered. I know tai chi is fantastic as well. When I can't walk due to inflammation (which is right now) I put on music and move my upper body.
So, has anyone found a combo of meds and natural practices that has helped?
Pain and stiffness improved 75% for me.
No Rx meds x 1 year.
uggg! Bio freeze works good sometimes...but the smell, well I get that old people look...lol!
Thanks!
Debbie
Please don't do anything to harm yourself. It sounds like there are people in your life who love you very much and would be devastated without you. You are a person of worth and you still have lots to give to and receive from the world. Having as many illnesses as you do probably predisposes you to some depression - I know this is something I struggle with from time to time. Instead of harming yourself, I encourage you to seek out help and perhaps a medication (I know, one more pill :-) that will help you see through this fog. You'd be surprised at how much it can help! Try to take each day one day at a time. Talk to your family about your feelings. I will be praying for you, Paula.
apnea and probasbly some things I've forgotten. I must sleep with a C-Pap and I have oxygen 24/7.
I am now 67, I have already outlived my entire immediate family including my baby sister who was three years younger than myself. I just tried to hibernate through the first anniversary of her death on September 10. I feel sorry for all the families in New York City and from the Pentagon but I have a whole lot of pity for myself right now.
At 67 and every bone, joint, nerve, and muscle in my body aches, burns and stiffens up to the point that I can barely move. I have worked through a lot of stuff but I am willing to tell you that I don't really care how much longer this is going to last. Tomorrow would be a good day to let it all go. The few things I would have trouble leaving in this world are my husband Allen, my niece Becky and her beautiful children. I just hope if I decide to do something considered stupid, they will forgive me.
Believe me when I say it does not get any easier when you get older. Do what you can to survive and trust that my heart goes out to you all.
started about a year ago. I could not walk for six months with out a stick. Now i am close to jumping rope. This is what
i did after refusing many of the RA drug, alkaline water , white grape juice, sour cherry juice and stopped eating foods
that caused my flaw-ups like sugars, salt, fried foods and pork. Good luck
I have Lupus ,Ostheoartritis, Osteoporosis level 3.9,artritis, IBS and Fibromalgia
I know how painful are all this condition togheter; to all and each one you blessing .
Vitamin D OTC & perscription. I take Naproxen
daily & was given Vicodin @ the ER on this past Labor Day because I woke up & couldn't walk. I'm constantly falling & the Prednisone makes me hyper,even though it's only 15mg.Does anyone
else experience falling. The Rheumotologist wants to increase the Prednisone. Any advise?
Also,how can you get people to understand? I have good days & then there's bad days.
I just had my first injection of Humira at $1500 an injection but my MD wrote to Abbot Labs Foundation,& thankfully my Humira is covered. I have not noticed a difference yet.
I found another rheumatologist because that was the third time the first one gave me incorrect information and guidence. I was sure I knew when I was sick!! Apparently he didn't think I could figure that out. So, I appreciate the above information.
old.I am 57 years old now I take Enbrel, methotrexate,plaquenil,calcium,folic acid and
vitamin D. I do have joint deformity knuckles with my hands also I have had surgery on both feet, it went very well for me . I was in a great deal of pain,especially in the morning.On a few occasions I have taken steroid shots to ease the pain. I now do water aerobics at the local Y ,I will say this was one of the best I could have done for myself beside my physician .I have more energy, flexibility and no pain.I still take my meds and I'm sure they help also but the water I beleve was the big change for me, it has changed my quality of life. I have not had a steroid shot in 3 years.I've been doing the water classes about that long.
the progress of my ANkolosis spondilitous
iwas told of the side affects and got a 2nd opinion
was told to try it for 3 months so I did I started getting a
really bad rash right away and I went to a regular docotor and told him I was on humerus but he said
that wouldn't cause the rash I had so I contours to
take it for the 3 months and it got worse
I finnaly stopped the humeria and it has taken over a year and I think it might finnaly be gone
the doctors still are not sure if it was the humeria
but there is no way I will take it again
I am 62
I began Enbrel in 1999. It was a miracle drug. I had been on medical leave from work for 6 months and getting in and our of a car was very difficult.With Enbrel, I went back to work and getting in and out of a car was no problem. The Enbrel worked for about ten years and then became ineffective. I began to take Humira and all was well. Still is so far. I have good insurance or could not afford the Humira. It cost about $1800 a month. I hope the price come down for others.
I think the key may be that just like everyone's disease process is different even in two people with the same disease, like RA, the response to treatment is likely to vary as well.
I have been on Orencia for almost a year and I have had the best results from any treatment I have ever had. No fluid, on any joints. Just have to deal with the resulting OA.
The best weapon is to be an informed patient and assertive when you need to get what you need. If you doctor won't listen to you, you may want to try someone else, if you have someone else in your area, or reasonably close if you have to go out of town (I used to drive 2 hours to Houston), to get the help you need.
The Dr. took blood tests and all was good there.
Thanks
My friend who does not have diagnosed arthritis but has had severe dizziness and treatments for such was finally suggested it was meniere's disease. It was suggested she severely limit her intake of salt/sodium. Although difficult, as even vitamins can have sodium in them, it has made a huge difference in her life. Maybe it can in yours too.
To Joni,
I am so sorry for your rheumatologist saying you just have to live with the pain. That seems counter to what all the doctors who write for Arthritis Today say to us readers in their monthly articles. If possible, seek help from a different rheumatologist to see if there might yet be relief.
I have had RA since 1995 and been taking enbrel since 2004. Recently I notice what may be some breakdown in its effectiveness.
I appreciated reading everyone's comments, we just never know when our shared comment may help another!
I then started Rituxin and became very ill with a liver virus; it was thought by several doctors that most likely my lowered immune system allowed this virus to become problematic. Needless to say, I no longer take Rituxin and would have to be in extreme pain to even consider another biologic.
To those who have a pleural effusion: Mine was drained, no big deal and no problems since.
My understanding is people like me with autoimmune disorders are prone to more autoimmune disorders... so lucky! I hope this was helpful, you are the first person I have heard that also has the ear issues.
I already had pretty bad joint deformity before I began Enbrel. I don't feel like the Enbrel makes any difference in my life. I have 2 joint replacements, and every day I struggle from pain. I am bearing weight on an ankle with most of the cartilage gone. In my case, the risks of Enbrel are greater than the benefits.
The one thing that made my life easier and improved my quality of life was hydrocodone. But suddenly my rheumatologist wants me to eventually stop taking it and has offered no suggestion of any other pain killer. In fact, he told me I would have to "learn to live with the pain."
Western medicine makes no sense to me when a doctor would feel comfortable prescribing a high-risk drug to a patient while at the same time asking them to live with constant pain.
Suffer from several types of arithritis: psoriatic, spondaylosis(sp),ortho, etc. Have tried several TNF's with out positive results. InflAMATION. bONE AND JOINT DESTRUCTION CONTINUES. Any ideas. nUCEALOR ANITBODIES THRU CEILING.
f's
These drugs affect the immune system where these diseases strike.
When you're messing around the immune system there are going to be serious risks.
YOU need to do your research about your disease and treatment options and talk with your doctor, rheumatologist, gastroenterologist or whoever you are seeing.
It is YOUR decision about what treatment you allow. YOU have to weigh the benefits against the risks for yourself!
These treatments do not work for everyone; they are miracle drugs for some.
I am an infusion nurse and administer many of these meds to people who without them would be suffering greatly and not able to participate in any kind of 'normal' life. I have seen a few who cannot tolerate the meds because of side effects, but in almost 20 years of nursing I have only seen one case of a serious result in an elderly woman who developed lymphoma after starting Remicade.
I am also experiencing a severe loss of hearing due to an inner ear disfunction.Has anyone had ear problems due to an auto-immune disease? I wonder if maybe I should also take methrotrexate in addition to the enbrel. I am 65 years old.
To the people who've asked "is it worth the risk"...yes it is. Remember that inflammatory arthritis is wreaking havoc on our bodies affecting other organs besides our joints. The best thing we can do is to tamp down the inflammation caused by our immune system run amuck. To let it continue to do damage unchecked is, IMO, not a good option.
I mean duh - its doesn't make common sense to suppress one's immune system.
It's suspicious how a drug with these known side effects (cancer, and many other diseases) could be approved for use - as it seems irresponsible.
After noticing I was getting severe sicknesses like bronchitis, I quit using Enbrel - even though it was pushed heavily by my doctor and I was getting it delivered to me under an assistance program (Its very expensive - over $1,000 per month).
I have psoriatic arthritis and during 35 years of treatments noticed that different doctors would press me to use specific medications - that I found lots of promo material around the office for those drugs.
Made me wonder about the gratuities - ie vacations and other benefits - that the doctors may have been given in exchange for promoting a drug.
I have been on methotrexate for over 25 years - and its worries me.
How bad woild a small dose of prednisone daily and not the other meds, be?
I have had RA since 2007. I am 69.
I literally got out of a wheel chair lost 65lbs and never looked back Yes I am more susceptible to infections using Remicade but I am very aware of my body and the first sign of being sick I get to the doctor as unlike a healthy immune system I will get sick very quickly.
The trick is to take supplements to boost your immune system. Bioastin is a fabulous product that everyone should take. Dr Oz said the same exact thing. The water is your best friend when it comes to exercise with joint problems too.
I hope someone finds this helpful.
INE.IF I GET SICK IT IS
LIKE IT WAS BEFORE STARTING THE SHOTS.I ALWAYS FEEL SO MUCH BETTER.I HAD A TOTAL HIP REPLACEMENT FOUR YEARS AGO AND DOING WELL.
I teach 3rd grade and I'm constantly exposed to all types of infection. What is your opinion?
pneumonia in June 2011 after being on Humira for RA. I was hospitalized for ten days and have take Bactrim to prevent reinfection while taking Humira. PCP is a fungus present in the air just like pollen, dust, etc.
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