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Do Enbrel, Humira, Or Remicade Cause Cancer In Children And Young Adults?

FDA Will Conduct A Safety Review Of These TNF Blockers To Investigate This Possible Link

(Posted by Tom Lamb at DrugInjuryWatch.com)

On June 4, 2008 the FDA issued an "Early Communication About an Ongoing Safety Review of Tumor Necrosis Factor (TNF) Blockers" announcing that the agency has started an investigation into the potential link between certain TNF blockers used to treat Juvenile Idiopathic Arthritis (JIA), Crohn’s disease, or other diseases and the development of lymphoma as well as other cancers in children and young adults.

According to this June 4 article, "FDA Investigates Link Between TNF Blockers and Pediatric Cancer", published online by Medscape Medical News:

Approximately 30 cases of cancer have been reported during a 10-year period extending through April 2008, occurring in pediatric patients receiving TNF blockers with other immunosuppressive therapies to treat juvenile idiopathic arthritis, Crohn's disease, or other conditions. About half of the cancers were Hodgkin's and non-Hodgkin's lymphomas; leukemia, melanoma, and solid organ malignancies were also reported, the agency said.

TNF blockers currently approved for pediatric use include etanercept (Enbrel, Immunex Corp, marketed by Amgen and Wyeth Pharmaceuticals), adalimumab (Humira, Abbott Laboratories), and infliximab (Remicade, Centocor, Inc). Makers of these products have been asked to supply the FDA with information regarding cancer cases in children receiving treatment….

As part of the 6-month review process, the agency has also contacted medical experts to assess the potential link between TNF blockers and cancer and also whether some children may be at particular risk for malignancy.

After this FDA safety review of Enbrel, Humira, and Remicade is complete, and the agency has reported its findings, we will let you know if there are any resulting recommendations to doctors and patients.

As with all serious side effects from prescription drugs, any adverse events related to the use of Enbrel (etanercept), Humira (adalimumab), or Remicade (infliximab) should be reported to the FDA's MedWatch reporting program by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.

P.S.  On August 4, 2009, the FDA issued a MedWatch 2009 Safety summary, "Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, Cimzia, and Simponi) August 2009", announcing that:

[The FDA] has concluded that there is an increased risk of lymphoma and other cancers associated with the use of these drugs in children and adolescents. This new safety information is now being added to the Boxed Warning for these products. FDA has also identified new safety information related to the occurrence of leukemia and new-onset psoriasis in patients treated with TNF blockers. The current prescribing information for TNF blockers does contain a warning for malignancies, but does not specifically mention leukemia….

We will continue to monitor the various serious side effects associated with Enbrel, Humira, Remicade, and these two other tumor necrosis factor (TNF) blockers.  (8/5/09)

37 responses to “Do Enbrel, Humira, Or Remicade Cause Cancer In Children And Young Adults?”

  1. Craig Niedenthal Avatar
    Craig Niedenthal

    Tom: I had a remicade case a couple years ago and this drug and its related drugs is dangerous as hell. Really bad side effects. At that time it was known that in adults it could cause cancer, so this is no surprise. Thanks for the update.

    Reply
  2. Tom Lamb Avatar
    Tom Lamb

    For those of you who don’t know, Craig Niedenthal — who submitted the comment below — is a very good plaintiffs lawyer in Alabama.
    A few years back, before Humira came on the market, my law firm investigated many possible cases involving diverse, serious side effects from the use of Enbrel and Remicade. We ended up filing a few Remicade lawsuits, which were later settled.
    Depending on what the FDA finds during their safety review, there may be more lawsuits concerning Enbrel, Humira, and Remicade in the future.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

    Reply
  3. Stephen P. Wendell Avatar
    Stephen P. Wendell

    my son died dec. 6, 2007 from hepatosplenic peripheral t-cell lymphoma induced by the combination of remicade/humira and 6 mercaptopurine. we have reported his death to the fda. we need advice about our recourse regarding product liability lawsuits for wrongful death against the manufacturers of these drugs on the basis of failure to warn.

    Reply
  4. Bob Avatar
    Bob

    I would like to add my comments regarding Remicade. I was diagnosed with Crohn’s. The first year of treatments I came down with Shingles. The emergency room doctor said mine was the worst case he had seen in 33 years. The second year of treatments I came down with throat cancer and had 66 limp nodes removed.
    This drug kills and should be removed immediately before anyone else gets sick from it.
    I spoke with my gastrology doctor yesterday while I was having a feeding tube put in and he said he wish he had never put me on it. He also said he was definitely considering not putting people on it anymore. Hopefully more doctors will stop prescribing it too.

    Reply
  5. Tom Lamb Avatar
    Tom Lamb

    I appreciate you taking the time to share with us your unfortunate experience with Remicade.
    We will continue to monitor Remicade in terms of adverse events and FDA action. Any significant developments will be reported on Drug Injury Watch.
    Thanks for reading, and we hope you subscribe to Drug Injury Watch by email or RSS (see the sidebar at right side of page for each of these delivery options — both are free, of course).
    Tom Lamb

    Reply
  6. Brent Vincent Avatar
    Brent Vincent

    I have chrons disease. I just started Remicade a little more than a year ago. What’s great about it is that it is helping my chrons. However, I have noticed that there are a couple of lumps in my arms that were not there before i started taking this medicine. After reading these comments, I will make sure that I go and get cancer screening ASAP and consult with my doctor about a different medication. Thanks.

    Reply
  7. Tom Lamb Avatar
    Tom Lamb

    The decision about whether or not you should continue using Remicade is one for you and your doctor to make, as you understand.
    The FDA advises that you should not stop taking any prescription medication before talking to your doctor.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

    Reply
  8. Alisha Carter Avatar
    Alisha Carter

    My name is Alisha,and I was diagnosed with Crohn’s at age 13..I’ve had 3 surgeries and sometimes get iriitis.I’ve been on a lot of medications like prednisone,6-MP,Imuran,Asalfudine,Entocort,and now I’m taking Remicade..I started Remicade about 6 months ago to help my fistulas and SI joint pain..Its brought me much joy..I can walk upright,run,jump,exercise,even got back in the gym..So far I haven’t had any problems,but I’m interested in comments..

    Reply
  9. Tom Lamb Avatar
    Tom Lamb

    Alisha:
    I am glad Remicade is working well for you.
    Perhaps some other readers of this post can share their Remicade experience with Alisha, as she has requested.
    My best to you in all aspects going forward.
    Tom Lamb

    Reply
  10. Nicole Ferrara Avatar
    Nicole Ferrara

    Tom,
    My 26 year old sister died last year from small bowel adenocarcinoma-cancer. She was diagnosed with Crohn’s at age 11 and had been on various steriods, etc.when she was younger. For approximately the last 4 years she had been receiving Remicade treatments and my family is convinced that the Remicade treatments were a direct link to her cancer. Her cancer was incredibly rare especially in someone her age. We saw all the specialists in Chicago but no one could save her. My family would like to warn people about the risks of Remicade. Should I call the FDA and report this? I have the medical documents to prove everything. My family may want to pursue a law suit. My family lives in Chicago, however, I live in NY. Thank you for any information you may have.

    Reply
  11. Julie Them Avatar
    Julie Them

    I started treatment for rheumatoid arthritis with Humira around March/April of 2004 and three months later was diagnosed with the rare cancer call Acute Myelogenous Leukemia. I won’t point my finger at Humira but would hope that the studies be long enough before biomedicals are released for public consumption. Are there others who have had this diagnosis using Humira?

    Reply
  12. Tom Lamb Avatar
    Tom Lamb

    Nicole:
    Yes, you can report the unfortunate death of your sister to the FDA.
    Here are links to some pages at our web site, Drug Injury Law, which will tell you about the FDA’s MedWatch program and how to submit a report:
    http://www.druginjurylaw.com/drug-injury-reporting.html
    http://www.druginjurylaw.com/medwatch-report.html
    I wish you and your family the best in all aspects going forward.
    Tom Lamb

    Reply
  13. Tom Lamb Avatar
    Tom Lamb

    Julie:
    I hope you are doing as well as can be, and thanks for sharing your experience with us.
    To the extent that you or your doctors think there may be some connection between the Humira and your Acute Myelogenous Leukemia diagnosis, you can make an FDA MedWatch report. (See my reply to Nicole, just below, for information).
    If anyone knows of a similar situation, please let us know so that it can be shared with Julie.
    Tom Lamb

    Reply
  14. Lisa Avatar
    Lisa

    I have a diagnosis of Crohn’s Disease. I had received four infusions of Remicade when I suffered a stroke. Everytime I received a Remicade infusion I would get sick with flu symptoms 2-3 days after, and would have numbness in my right hand for several days afterwards. My doctor said that The Remicade wasn’t responsible for the stroke, but all of the post stroke tests I had ie: MRA, blood panel for stroke and cardiac tests all came back fine and normal. I think that the Remicade did play a part in my stroke.

    Reply
  15. Tom Lamb Avatar
    Tom Lamb

    Lisa:
    I am sorry to hear about your stroke event after the Remicade use.
    You may want to let the FDA know about your concerns by means of submitting a MedWatch report. The link below will give you more information about the that process:
    http://www.fda.gov/medwatch/
    I wish you the best in all aspects going forward.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

    Reply
  16. Maureen Avatar
    Maureen

    I have been on Enbrel for 8 months and had a pap test come back abnormal. My Doctor did a biospy because he believes the cells were precancerious. Any relation to the Enbrel? I’m 23 and would image that is still considered a young adult. Thank you for you time.

    Reply
  17. Tom Lamb Avatar
    Tom Lamb

    Maureen:
    Being only an attorney and not a doctor, I am not in a position to answer your medical question.
    If you suspect that Enbrel may be involved in the abnormal test results, you should discuss it with the doctor who prescribed the Enbrel to get their impression. You may also want to report it to the FDA through their MedWatch program (there is a link for that web site in the sidebar to right of column).
    I wish you the best in all aspects going forward.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

    Reply
  18. Lisa Avatar
    Lisa

    I have been taking Enbrel for about 10 – 12 years. I recently was diagnosed with Stage 4 Melanoma of the Brain. I had no idea that immunosuppresants could cause this.

    Reply
  19. Lisa Avatar
    Lisa

    Forgot to mention I was diagnosed with Rheumatoid Arthritis about 20 years ago (24 years old at the time).

    Reply
  20. Tom Lamb Avatar
    Tom Lamb

    Lisa:
    Sorry to hear about your recent diagnosis.
    We wish you the best in all aspects going forward.
    Tom Lamb

    Reply
  21. ANNie Avatar
    ANNie

    “30 reported cases” IS WRONG. There are MANY more reported cases of cancer. See the 2003 FDA Arthritis Advisory Committee docket available on the FDA website. Centocor is MISLEADING THE PUBLIC!!

    Reply
  22. Tom Lamb Avatar
    Tom Lamb

    Annie:
    I appreciate you giving us this lead about the number of cancer cases reported.
    I haven’t had an opportunity to look at the FDA document you reference. Does it distinguish pediatric cases from adult cases?
    Thanks for reading Drug Injury Watch.
    Tom Lamb

    Reply
  23. Shawn Avatar
    Shawn

    I was diagnosed with RA March of 2008 and then April of 2009 my Rheumatologist changed the disagnosis to Undifferentiated Spondyloarthropathy due to problems with my shoulders.
    I started looking on online because I wanted to see if bruising and petechiae are side effects of using Humira. I have been on it for about 2.5 months and just recently started bruising horribly and developed petechiae on my left arm, knee and heel. I had a muscle cramp on my left leg that resulted in a nasty bruise. The bruising and petechiae are abnormal for me, but I am lost because I have had problems with headaches in the past, but they are back more frequently now and I am so tired all of the time. Is this familiar to anyone? I can’t seem to find a straight answer to my questions online.
    Thanks.

    Reply
  24. Joe Rheum1 Avatar
    Joe Rheum1

    The relative risk of lymphoma is increased 3.0 in rheumatoid arthritis over people who do not have RA. The unanswered question is if any of this can be attributed to the drugs like methotrexate, enbrel etc or is just people with the most severe RA (thus highest lymphoma risk) are more likely to be given the most effective drugs with more risk.

    Reply
  25. Joe Rheum2 Avatar
    Joe Rheum2

    In 8-10 years of uncontrolled RA multiple joints are destroyed if it untreated. The combination of Methotrexate + Enbrel slows the rate of joint destruction by 95% or more. So in balancing whether to take these medicines one must consider the substantial benefit vs. the possible but infrequent side effects.

    Reply
  26. Tom Lamb Avatar
    Tom Lamb

    Joe:
    I agree with you; as with all prescription drugs, for Enbrel and all drugs in its class there should be a continuing, current risk-versus-benefit analysis.
    I hope your keep reading Drug Injury Watch.
    Tom Lamb

    Reply
  27. Joanne Godfrey Avatar
    Joanne Godfrey

    I lost my mother in Februrary when she developed Leukemia after being on Humira for nearly two years. I was with her when she chose to go on the drug, but she was not told of any risks, even though I asked for her at the time. What happened to her was very wrong, but in Australia doctors are too afraid to rock the boat. I need to report this to someone but don’t know who. Can anyone help?
    Thanks,
    Jo

    Reply
  28. Angie Metten Avatar
    Angie Metten

    My husband is 49 years old and was prescribed Humira in April 2008. The last injection of Humira that he gave himself was June 30, at approximately 7pm. He had a massive stroke in the early morning of July 1, 2010. I know that the Humira caused his stroke and after researching further I found out that the longer a person takes Humira, the chances of a heart attack or stroke increase as Humira can cause blood clots along with many other things. Also, Humira was given a “black box” warning in August of 2009. This is the harshest warning that a drug is given but evidently most doctors aren’t even aware of this warning. Had we been informed of this warning my husband would have stopped Humira immediately. Thank god I still have my husband but our lives has changed drastically because of Humira and we are praying that nothing else is going on in his body because of this drug.

    Reply
  29. Tom Lamb Avatar
    Tom Lamb

    Angie:
    Thank you for sharing this information with us.
    Certainly, I wish your husband and you the best in all aspects going forward.
    Tom Lamb

    Reply
  30. Lisa Barker Avatar
    Lisa Barker

    Hi,
    I just found this article and it is helping me decide what to do regarding my daughter. She has inflamation in her body and iritis. She was dx with Uveitis July 2010. She has been on methotrexate for 6 months with no improvement. She is also on 3 eyedrops. We were seen yesterday at Duke and were told to add Humira to her regimen. We were told this can increase her chance of cancer. She is 11 years old. This is scary as —-! Her inflamation will effect her vision if it is not treated. Thanks for all of your comments. I am still researching all of this. This website defenitelly, has me asking for a 2nd opinion.

    Reply
  31. Ashlee Avatar
    Ashlee

    Deciding on humera or remicade for my daughter who has mild crohns. She is 11. I don’t want to put her on either drug due to the horrible side effects. Dr said she is not growing and will be the samesizeshe is now at 18. What alternative medication has shown to allow for a child to grow but without the life threatning side effects? I
    Thanks

    Reply
  32. Tom Lamb Avatar
    Tom Lamb

    Thank you for your Comment.
    Please understand, however, that because I am not a physician but only an attorney I am not in a position to give any medical opinion as regards your daughter’s situation.
    Perhaps others who read the inquiry concerning your daughter can respond with advice, guidance, insight, etc.
    I wish your daughter and you the best in all aspects going forward.
    Tom Lamb

    Reply
  33. April Skinner Avatar
    April Skinner

    Lisa, my name is April. I am currently going through the same situation with my 7 year old son. Chronic bilateral uveitis, since Feb 2015, methotrexate is not helping and now Duke wants to put him on Humira. Just wondering what you decided to do and how your daughter is doing.

    Reply
  34. Concerned Daughter Avatar
    Concerned Daughter

    GM Mr. Lamb,
    I am writing you because my mother 68 urs young who is one of th strongest woman I know was diagnosed w non Hodgkin’s lymphoma due to Humira. I feel a lot was not properly done and she was not properly aware of this medication that deteriorated her. My brother and I watched as my mother who is extremely independent become completely dependant on us. It was an extremely difficult and long journey but her amazing doctor said she is cured 2 months now. I wish they can pull this drug off the market.

    Reply
  35. Tom Lamb Avatar
    Tom Lamb

    Thank you for sharing this unfortunate story with us.
    I wish your mother as well as your family the best in all aspects going forward.
    Tom Lamb

    Reply
  36. Tracy Andrade Avatar
    Tracy Andrade

    My son who just turned 7 also has chronic anterior uveitis and started on three drops a day now on 5 drops a day and Methotrexate. It has not gotten much better so now he is on Humira and I’m so scared of the increased chance of cancer. They say it’s rare but what he got at his age was also rare. I’m wondering if anyone has found any natural ways of helping this..like herbs please write me junedecember33@yahoo.com

    Reply
  37. Maria Fiore Avatar
    Maria Fiore

    My son has Croahns his doctor put him on Remicade and then humira they had him on these medications for years saying he get better last year my son had brain cancer which I belive was caused by these medications stage four after 10 hour surgery he is blind and still has cancer these medications need to be taken off the market so no one else will suffer like my son is who is going to die from this I need a good lawyer who will help he can’t work no more and spend his days mostly in bed

    Reply

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