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FDA Investigates Possible Association of Enbrel, Humira and Remicade with Lymphoma Cancer in Children

Although this article is from 2008 it is no less relevent and well worth reading before you/your chicldren concider using these drugs. Back in 2007, when I asked my gastro about Humira, she told me straight that it could lead to MS.

The FDA is conducting a safety review of several medications used to treat arthritis, Crohn’s disease and other conditions among children. The agency is investigating reports of children and young adults using Remicade, Enbrel and Humira who developed lymphoma and other cancers.

The arthritis drugs, known as Tumor Necrosis Factor (TNF) Blockers, are commonly used along with other immunosuppressive drugs, such as methotrexate, azathioprine or 6-mercaptopurine, to treat Juvenile Idiopathic Arthritis (previously known as Juvenile Rheumatoid Arthritis), Crohn’s disease and other immune system diseases.

According to the FDA’s Adverse Event Reporting System, between 1998 and 2008, approximately 30 children using Remicade, Enbrel and Humira reportedly developed cancer. About half of the cancers were lymphomas, including both Hodgkin’s and non-Hodgkin’s lymphoma. The other cancers included leukemia, melanoma and solid organ cancers.

The “early communication” issued by the FDA does not mean that there is a definitive causal connection between the drugs and the emerging safety issue, but the agency is investigating a possible association. All of the drugs currently carry information about a possible cancer risk, but experts have been looking for clarification about the risks among children.

“While cancers are known to occur in children and young adults, the reports of these events in children and young adults receiving TNF blockers are of concerns and deserve further investigation,” said the FDA in a statement released Wednesday. “Long-term studies are necessary to provide definitive answers about whether TNF blockers increase the occurrence of cancers in children because cancers may take a long time to develop and may not be detected in short-term studies.”

The auto-immune disorder drugs are huge sellers nationwide, and the revenue generated account for a large portion of the total revenue for the pharmaceutical companies who sell the drugs. Remicade, which is manufactured by pharmaceutical giant Johnson & Johnson, reported revenue of nearly $1 billion in the first quarter of 2008, which is about 6% of the Johnson & Johnson’s total revenue for the quarter. Abbott Laboratories, Inc.’s Humira generated $878 million in first quarter sales, compared to total quarter revenue of $6.76 billion for the company. Enbrel, which is marketed jointly by Amgen, Inc. and Wyeth, generated $951 million for the quarter, compared to combined revenue of $9.3 billion for both companies’ first quarters.

A fourth TMF blocker, known as Cimzia, is manufactured by UCB and was just recently approved by the FDA on April 22, 2008. The manufacturer is beginning a ten year study next year to access the long-term risks of Cimzia, including lymphoma and other cancers.

Despite the risk of childhood cancer possibly associated with Remicade, Enbrel, Humira and Cimzia, the FDA does not indicate that recalls or a change in approval for use in children is being considered. The statement suggests that the potential benefits still appear to outweigh the potential risks for children and young adults. The regulatory agency has requested that the drug makers provide information about any reports of cancer in children taking their drugs. It is estimated that the FDA safety review will take about six months to complete and determine what conclusions or recommendations will be made.

See comments on this article by searching title. I'm a newbie and can't post links :ycool:

There's also this one from 2013: Humira for Ulcerative Colitis May Not Be Effective: FDA Staff


There is a lot we don't know but the studies have been demonstrating the drugs are safer than originally thought. Personally I think it's a lot more dangerous to not put patients on these drugs and let their disease fester and increase their cancer risk than by worrying about the what ifs of drug side effects.


Staff member
^You need an account to medscape but it is free.

Personally, as a parent of two kids with autoimmune/inflammatory illnesses, I am much more scared of the diseases than of the medications. Plus both IBD and Juvenile Idiopathic Arthritis increase the risk of various kinds of cancer.
Thanks for your replies and links. I spent many months in various uni databases reading peer reviewed findings, but they didn't stop me using the bathroom anywhere up to 19 times a day. Nor did anything my gastroenterologist prescribe for me.

I'm not arguing or debating anyone's chosen treatment for either themselves or their children. Everyone knows what is best for them and/or their child. We each have our bent, our intuition to lead us down whichever path to healing that may be. I'm only here to share what worked for me but already get the feeling that the door is quite closed.

My youngest just turned 26yrs, is healthy and leading a full life. So I am really in no position to understand what it is like to have a sick child. My daughter (30yrs) had IBD aka Irritable Bowel Syndrome here in Australia and cured herself without drugs and now has a very active life running after her beautiful toddler daughter.

I think I'll continue this in the intro thread.

Thanks again.
Nym, no matter where you are from, IBD(Inflammatory Bowel Disease) and IBS(Irritible Bowel Sydrome) are never the same thing.

IBD(Inflammatory Bowel Disease):

Inflammatory bowel disease (IBD) involves chronic inflammation of all or part of your digestive tract. IBD primarily includes ulcerative colitis and Crohn's disease. IBD can be painful and debilitating, and sometimes leads to life-threatening complications.

IBS(Irritable Bowel Syndrome):
Irritable bowel syndrome (IBS) is a common disorder that affects the large intestine (colon). Irritable bowel syndrome commonly causes cramping, abdominal pain, bloating, gas, diarrhea and constipation. IBS is a chronic condition that you will need to manage long term.

Even though signs and symptoms are uncomfortable, IBS — unlike ulcerative colitis and Crohn's disease, which are forms of inflammatory bowel disease — doesn't cause changes in bowel tissue or increase your risk of colorectal cancer.
Sourcing the same site.

IBD causes ulceration, inflammation and scar tissue in the bowels. It can cause abscesses, fistulas, and fissures. IBS causes none of these things....Two totally different things.


Staff member
^ yes, which is why we treat our kids. We research extensively and make choices no parent should have to make. For some of our kids, these drugs work like magic and give them their lives back.
The research you have posted is outdated. More and more GI and Rheumatologists believe that these drugs are much safer then initially thought. My daughters and husband are in a study, and the head researcher told us that they have found that the only type of cancer risk that Anti-TNFs increase is non-melanoma skin cancer.

These diseases on the other hand, do increase cancer risk.

Compared with children without JIA, children with JIA have 3-fold increase of risk on malignancy in East Asia. Seemingly neither methotrexate nor anti-TNF biologics increases the risk further.
Patients with long-term inflammatory bowel disease (IBD), ulcerative colitis (UC) and Crohn's colonic disease (CD) have an increased risk of colorectal carcinoma (CRC). Eaden's meta-analysis has shown that the risk for CRC in UC patients is 2% at 10 years, 8% at 20 years and 18% at 30 years of disease duration. It is now accepted that the risk of colorectal cancer is equivalent in both (UC and CD) conditions. Duration of disease is recognized to be the most important risk factor for CRC development. Extent of disease in another major risk factor.


reminder they can just cut off non-melanoma skin cancers in most cases. it'll leave a scar your kid can even tell stories about!
Sourcing the same site.

IBD causes ulceration, inflammation and scar tissue in the bowels. It can cause abscesses, fistulas, and fissures. IBS causes none of these things....Two totally different things.
Thanks for that, Clash. My daughter's gastro. most certainly diagnosed her (via colonoscopy) with IBS. She has also had a fissure.

Orchid: Cancer is the very least of my worries when mesasal has resulted in chronic renal failure. I even have that printed on a doctor's referral. Not quite so easy to cut out a kidney, and I was only on this drug for about 10yrs.

Mesasal Enteric Coated (mesalamine) Disease Interactions

Mesalamine (Includes Mesasal Enteric Coated) ↔ Renal Dysfunction

Moderate Potential Hazard, Moderate plausibility

Applies to: Renal Dysfunction

The use of mesalamine and other compounds which contain or are converted to mesalamine has rarely been associated with renal adverse effects, including minimal change nephropathy, acute and chronic interstitial nephritis, and nephrogenic diabetes insipidus. Renal lesions such as renal infarct, papillary necrosis, tubular necrosis and interstitial fibrosis have been reported in high-dose animal studies. Therapy with mesalamine and prodrugs of mesalamine should be administered cautiously in patients with impaired renal function or a history of renal disease. Renal function should be evaluated prior to initiation of therapy and periodically during therapy.


Novis BH, Korzets Z, Chen P, Bernheim J "Nephrotic syndrome after treatment with 5-aminosalicylic acid." Br Med J (Clin Res Ed) 296 (1988): 1442

"Product Information. Pentasa Product Information (mesalamine)." Hoechst Marion-Roussel Inc, Kansas City, MO.

"Product Information. Asacol product information (mesalamine)." Procter and Gamble Pharmaceuticals, Cincinnati, OH.

View all 10 references



Super Moderator
Hi Nym. :)

As Clash has said, IBD and IBS are two different things. IBD is a disease (disorder of function) and IBS a syndrome (group of symptoms) and Australia is no different in its differentiation between the two.

Sorry, I am a little confused, when you say your was diagnosed with IBS via a scope do you mean she was diagnosed due to exclusion of other diseases? In other word her scope was clear?

I am so sorry to hear that Mesasal caused you chronic renal failure. :(

Dusty. xxx
Thanks DustyKat. My daughter developed chronic diarrhea in her early 20s. When exclusion diets failed to produce any long-term benefit her doctor sent her for a colonoscopy. She was then told she had IBS.

Apologies for wrongly connecting IBS to IBD. I've heard so many from the US refer to IBS as IBD (irritable bowel disorder) in conversation. Must be the language morphing. When referring to my own situation I always say 'Crohn's'.

Ok, now that that's cleared up :D I'm off to paint the exterior of my house ... well, at least the porch area. It has taken a day of rest for my arm to recover from all the prep :boring: lol.


Super Moderator
It is good to hear that she is getting on well now. :)

Saying Crohn’s surely is less confusing! :lol:

Ugh prepping! I don’t so much mind the painting but the prepping. :voodoo: The past two days have been glorious here but today not so much, looking like its going to rain, typical weekend! :yfrown: Anyway…happy painting! :ybiggrin:

Dusty. xxx


Nym.. I want to say thanks for providing your findings. We have a 15 year old son that we chose the SCD and now 3 years later plays travel hockey and hockey for school and has gained 50 needed pounds.
No medicine no surgery no hospital visits.
We are thrilled that our doctor gave us the choice to chose diet instead of medicine.
We never know the long term of medicine.
That's why lawyers are making so much money

I don't think that's true at all about those medications apparently it's a lot safer then thought , and also my friends has lupus she's been on many of them she changes when one is less effective changes back and forth anyway she been on it for a very long time and her rheumatologist told her there very safe and some side effects are very rare