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WSJournal: Tougher Warnings on Remicade, Humira: unrecognized respiratory disease

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Posted 9/5/2008 3:37 PM (GMT 0)

Wall Street Journal report is here:  http://online.wsj.com/article/SB122054331213700023.html?mod=djemHL

First few paragraphs:
Tougher Warnings Ordered on Four Drugs
By JARED A. FAVOLE and SHIRLEY S. WANG
September 5, 2008

Federal regulators on Thursday demanded beefed-up warnings on the labels of four big-selling drugs for arthritis and Crohn's disease to alert patients to the risk of serious fungal infections.

The Food and Drug Administration ordered stronger warning labels for Johnson & Johnson's Remicade; Abbott Laboratories' Humira; Enbrel, from Amgen Inc. and Wyeth; and UCB SA's Cimzia. The companies have been cooperating fully with the FDA, said Jeffrey Siegel, leader of the FDA division that regulates arthritis products.

The FDA said it reviewed 240 reports of histoplasmosis, a particularly invasive respiratory disease with symptoms similar to the flu, in patients being treated with Enbrel, Humira, or Remicade. The FDA found one case of the disease in a patient taking Cimzia.

In 21 cases, health professionals didn't recognize the disease, leading to delayed treatment, prolonged hospital stays and death in 12 of the patients involved.

Of the 240 cases, an additional 33 patients whose treatment wasn't delayed also died...

Posted 9/5/2008 3:44 PM (GMT 0)
I just posted this too- read it in my local paper.

Posted 9/5/2008 4:21 PM (GMT 0)
I wonder how long all those patients were on biologics. This is depressing. shakehead
Posted 9/5/2008 5:11 PM (GMT 0)
Except this isn't really new information. I've known since way before I started on Remicade that it statistically makes you more likely to get many different kinds of infections. This is just one that's been specifically named. On the other hand, some take Remi for ten years or more with no bad effects.
Posted 9/5/2008 5:50 PM (GMT 0)
I got Kidney Disease from taking 'safer' 5ASA's such as sulfasalazine.  It took 7 years to get dx'd, went to many Dr's. and had my uterus checked out (not fun), I was made to feel like an idiot and like no one cared, no one had a clue!  The only symptoms I had were edema and frothy urine.  Why doesn't this get the same attention?

My symptoms of edema and frothy urine were not listed as side effects, Renal Disease and Nephrotic syndrome were.  So unless you research all the hundreds of the symptoms from each side effect how would anyone know?  Seriously, would anyone connect edema to kidney disease, no one I saw did?  I think there should be a database that these Dr's can go into so when you tell them of symptoms they ask you what meds you have taken, what you are taking and it relates all the info back, edema + sulfasalazine = likely Kidney disease.  If they had something like that...........just imagine all the lives that would save and the years wasted of being sick.

GRRRRRRRRRRRRRRR!

Posted 9/5/2008 8:33 PM (GMT 0)
Edema is listed as a side effect in my Asacol literature...interesting that it wasn't listed in your sulfasalazine, which is an older drug.

I agree this is depressing news.
Posted 9/5/2008 10:22 PM (GMT 0)

actually Judilyn, this is new info- while they have known that biologics make you more susceptible to infection, they haven't known that they also make you more vulnerable to fungal infection. Apparently, the type of histoplasmosis found in patients treated with tnf blockers is disseminated histoplasmosis, which affects all areas of the body, not just pulmonary. It's pretty serious, & often fatal. I'm a little freaked out! Out of all the cases reported to the FDA in which tnf blockers were being taken, 20% were fatal. I guess doctors were overlooking the possibility of fungal infection, & were assuming the illness was pneumonia. I think this is super depressing news- I was talking to my husband about it, & we don't know what to do. Either I stay on these drugs with all sorts of potential side effects, including death, or I go off & become seriously ill from my UC. My GI would advise surgery- he has in the past, anytime we talk about drug side effects. It just stinks- one more thing to worry about. I'm already a little bit of a hypochondriac, or at least I pay very close attention to my symptoms whenever I get sick. Don't tell me you don't get worried at times about just what exactly you're putting into your body? This news makes it easier for those who haven't yet started on the biologics- after winding up in ICU for a week, & now this new info, I wonder if I would have started Remicade if I had known what was ahead. Now, I feel like I'm stuck on it.

Posted 9/5/2008 11:18 PM (GMT 0)
I guess when someone tells me something "may increase my susceptibility to infections," I take that to mean all infections from whatever source - virus, bacteria, fungus, whatever. That's probably why this didn't seem like new information to me.

Before every new medication I've started, I've always measured the potential side effects against the possible relief and decided based on that. When I started on Remicade, I totally knew that I would prefer to chance dying than to continue to exist in the status I was in. So I do think about what I put in my body, but once I've made a decision I let it go. My decision tree now would be continuing Remi versus giving up 2-3 years of my life recuperating from surgery. If it comes to it, that's the decision I'll have to make.
Posted 9/6/2008 12:11 AM (GMT 0)
Well we know that Humira and the like have connections to Tuberculosis.

Does anyone on Humira or Remicade see themselves ever getting OFF these drugs? I don't. So this is scary news :(
Posted 9/6/2008 1:15 AM (GMT 0)
superdeejayanna--I saw a GI who said he only keeps patients on Remicade for one year and then tries to see if a less potent drug (6MP, 5ASAs) will keep the patient in remission. He has had patients before who have avoided surgery by this method. This is what I plan to do; and if it fails, then I'll be going in for surgery.
Posted 9/6/2008 11:41 AM (GMT 0)

Well, I'd like to talk with my GI about going back down to the 5mgs/kg dose when I see him next- I know that's what he would like. I don't even have any appt.s scheduled right now though. And I plan to try to extend my dosing schedule back out to 8 weeks- I've been going every 6, my next one I'll schedule for 7 & see how that goes. But getting off the biologics......nope. Only if I decided to opt for surgery. I'd love to get off them, but I'm scared to. I'm doing pretty well, & I'm afraid to mess anything up. Ya know what I see? I see these drugs being taken off the market in the next 10 years or so, for real. Not due to any major deaths, but due to the fact that I think they're going to see more & more complications from taking them, & at the same time they'll develop safer drugs to use that do the same things. Hey by the way, glad to hear you're doing well with the Humira! What a double-edged sword, huh?

Posted 9/6/2008 12:13 PM (GMT 0)
All medications come with some sort of side effect or potential infections. I just sort of chuckle when I see commercials for various meds and in a quick speech they tell of possible side effects. And I think, yeah ok that REALLY makes me want to take THAT med! Sometimes we have to weigh the pros and cons of any medication we take. I for one have opted to rather have surgery then go on Remi but not because of any possible complication but rather why hang onto an organ that is never going to work properly. Now after reading this, it makes my decision much more acceptable.
Posted 9/7/2008 4:14 AM (GMT 0)
Ah, I read the various articles also this weekend while searching for info on Remicade. I am going to be starting my first Remicade treatment Monday and this FDA warning coming out on the weekend before my first dose seems so ominous. I hope I don't become a statistic :(
Posted 9/7/2008 11:33 AM (GMT 0)
Thanks for posting this.
I have been on Humira since 1/01/08. My wife saw a Humira commercial the other day and she said that they mentioned "Potentially Fatal" as one of the side effects. I told her that I didn't remember that being mentioned when I started Humira.
I have been considering having surgery lately to have my colon removed. I wonder if it's time.
Posted 9/7/2008 5:32 PM (GMT 0)
The scary part is that the doctors didn't catch when/why the respiratory problems started. Yikes.
Be vigilant, be assertive!

When I've asked my GI about new treatments, she had said they are not worth the side effects for me. I had wondered about that, but I think she called it right.
If you have only been able to function with that harsh of a medication, and you continue to suffer anyway, I would think surgery would have to be a serious option.
Posted 9/7/2008 6:52 PM (GMT 0)
How often are we supposed to get our urine tested for histoplasmosis? I've only been tested once and I live in one of the problem areas.

This disease wouldn't be so bad if the meds weren't so scary. *sigh*
Posted 9/7/2008 6:58 PM (GMT 0)
An expected consequence of suppressing the immune system.
Posted 9/7/2008 7:26 PM (GMT 0)
Well I've known from the start that I'm more likely to get stuff, and I have. I'm 34 years old and I got Shingles and a number of other strange ailments. I wanted to say that I spent 8 days in the hospital last week b/c I had a case of "Bronchitis" that even the lung specialists can't seem to get fixed. They've done all they can and finally released me b/c they were afraid I'd catch more being in the hospital. I've been home a week now and  no improvements. My doc called me in a medication for fungal infections yesterday b/c he said he wants to be sure with this recent warning that this isn't what is going on with me. And trust me, they have looked in my lungs, bronchial tubes, taken biopsies, etc. They're all baffled. I'm not trying to scare anyone b/c I am not near death or anything but I can't do much more than take a shower and I've been out of work for weeks. I guess in the end it is a matter of whether the benefits outweigh the risks. Right now I'm wondering if I should try to stop the Remicade b/c things like this really aren't worth it. I have no history of asthma or any breathing problems and every day is a struggle for me right now. But I also know that if I stop the Remicade I will probably be a really sick person like I was before the Remicade. Sigh. sad   My doc is great though and I have faith he can fix me eventually. Even the lung doctor was like "you're on Remicade and that changes everything. It's a whole different ball game and list of things to consider." Yeah well get the list ready and get me fixed!!!  eyes
Posted 9/8/2008 1:12 AM (GMT 0)
I also knew about the medication brining the immune system down, I work with children, so I kinda feel like a pain in the neck when I get sick. I call the doctors office when I get sick and feel like it's not getting better. I guess I kinda want to be ahead of the game knowing that both my medications bring my immune system down. The doctor I talked to yesterday immediately put me on antibiotics cuz my cough seemed to settle in my chest and wasn't getting better. I think that if I'm ahead of the illness game with taking Humira and Imuran, I should be fine. I've been on Humira since May, 2007. Haven't had much side effects Thank God, cuz I really am unable to try any different meds. Allergic to Asacol, it makes me go backwards in my remission which isn't a good thing. So, I just monitor myself as close as possible.
Posted 10/18/2010 6:55 AM (GMT 0)
No one tells you before you have a total removal of your colon and a J Pouch what to really expect down the road post surgery. I am 13 and 11 years post op after two major surgeries since the first surgery was botched. I am finding the more time passes since then, the more complications seem to crop up in my life as a result. Here is something of what I have experienced as a result. I am not saying it's all post colectomy. Could be the history of Crohns also plays a role, but the colectomy, I am sure has played a major role. Your experience may be entirely different and positive. It's a crap shoot, I think.

I have a hx of Crohns. Developed dysplasia in colon along with family hx of colon cancer. Had total colectomy in 97 with many complications (sepsis, near death, JPouch malformation, bowel & JPouch reconstruction, etc.). Many IBD meds later, still ended up on Remicade for four years at the highest recommended dose and frequency. Developed a horrible Psoriasis looking rash over half my body about three years into it. After I got off Remicade, two months later, the rash went away.

No one ever told me about the complications of having my colon removed by over eager doctors at the VA Hospital. Afterwards, they shake your hand and pretty much tell you good luck and good bye. No one tells you about the long term effects of being colon-less. It's been 13 years now without a colon. A lot of watery diarrhea still...no less than 10 trips a day to the restroom and up to 15 or more on other days. I never know what sets it off. They say the JPouch is supposed to act like a colon eventually. Not mine! Magnesium to counter the chronic dehydration only gives me more diarrhea. I still have to be aware where all the restrooms are and I get up at night between two and six times to go with numerous accidents while I sleep. I am constantly plagued by severe leg and foot cramps which also awaken me at night.

Now I have chronic kidney stones: 3 kidney stone removal surgeries for up to 6 or 7 stones at a time in just this last year! More forming. My urologist throws his hands up in the air and is sending me to a nephrologist for more tests and consultation. Also it appears like I have some kidney disease also coming into view as a result. I still have problems with absorption and the food I eat exits within a couple of hours like it went in. I ask doctors and dietitians what I can eat to maintain good function and health. I get the one size fits all answers and then they scratch their heads or look at me like I'm from Pluto when I say how those things affect me.

I work like heck to live like a normal person and maintain an upbeat positive attitude of gratitude. Exercise, vegetarian, dating as a single, social life, family, lots and lots of laughter with friends, etc... But there are complications and I have to make trips to the ER more than I would like. They always admit me due to my history and complications.

Now I am told there are multiple enlarged lymph nodes in my sacral and spine region where all the surgeries went on. Could be anything from viral to cancer. It's a waiting game with more tests.

I am pretty accepting and mellow about everything...have to be or I would be a basket case by now, but I just like to see a little more research into nutritional needs, complications, side effects of being a post colectomy patient. It's a big question mark, and I have turned up every rock I can looking for more information to help myself. I have learned that just because they take your colon out doesn't mean that you get to skip away or receive a get out of jail free ticket. It's a trade-off; and it requires the utmost dedication and commitment on your part to take the very best care of yourself you possibly can with stress levels, sleep, nutrition, a balance between play and work and asking lots of questions until you find the right answers that work for you. And not letting the medical establishment intimidate you.

No one ever said life was fair though. Maybe we just always get what we really need in order to learn, grow, and find our way back to the Light and be of service to one another. I have learned there is still lots of joy filled life left after a total colectomy and illness; in fact, maybe because of it, I am often surprised by the joy and appreciation of the life I have.
Posted 10/18/2010 11:23 AM (GMT 0)
This is absolutely terrifying. Suzi322, I'm sorry to hear of your complications with surgery. We're at the point of choosing immunosuppressants vs. surgery for our daughter and have been leaning toward surgery but lately I've been hearing a lot of horror stories. Do you mind me asking why you were given a jpouch with a CD diagnosis - I didn't think it was possible. We were told if we had surgery and the sx was determined to be CD by pathology, the ostomy would be permanent? It's so confusing and the more GIs you consult, the more confusing it gets.
As for Remicade, I would personally only use it if I had a CD diagnosis and NOTHING else worked (diets, Enteral Nutrition, all other meds etc). If nothing works, however, I guess you have no choice but to use these drugs. I agree with Eva Lou, these drugs have only been used very short term and I think the longer term effects of them will become visible in the next 10-15 years.
Posted 10/18/2010 1:36 PM (GMT 0)
well, re. the original post- I remember when this info came out, I was terrified- yet another worry about the biologics! I did speak with my PCP about it, & basically, as long as your PCP is aware of the meds you take, if you were to wind up quite ill with a flu/respiratory infection, they'd be pretty quick to test you for histoplasmosis. Plus, unless you live in the few areas where it's prevalent, it's not all that common. There are a few places in the states, Ohio is one, where it's pretty common. But lucky for me, not so much in New England! I don't know, here I still am, 2 years later, still on biologics & doing alright. Ask me how I am in 10 years...

Posted 10/18/2010 1:50 PM (GMT 0)
I didn't realize this thread was so old. I just saw it and freaked out.
Eva Lou, I hope you'll be doing great at 10 years. The GIs swear that the biologics have revolutionized IBD treatment and really "saved" many lives, so I guess you have to look at it that way.
Posted 10/18/2010 2:48 PM (GMT 0)
I just saw this also. How scary. eva lou-I agree I'm on remicade and I told my husband they only know about the last ten years side effects what about twenty or thirty years. Scary. I agree uc isn't that scary it is the meds they use to treat it. uc doesn't sorten your life the meds do. But then you listen to some horror stories about surgeries and those scare you to. This sucks. I was hoping to get a few years on the remicade until my daughter was older and than it would be easier to have surgery. I'm freaked out all the time. Now hearing suzi322's story surgery scares me.
Posted 10/18/2010 2:59 PM (GMT 0)
I've lived in one of the prevalent histoplasmosis areas up until a couple months ago and never had an issue with histoplasmosis. (Heh, I was only on Remicade for a couple months when I originally posted on this thread)

J-pouch is given to UC patients; CD patients should not be getting them because of these sorts of complications. I'm more paranoid about surgery complications than side effects of biologics, so I stay on Remicade.

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