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Concern Increases over Side Effects of TNF Inhibitors in Treatment of Crohn’s and Colitis

Mark Silber

Last updated: October 26, 2016 7:13 pm

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A class of drugs known as tumor necrosis factor inhibitors (TNF inhibitors) has received the highest number of adverse events reported to the U.S. Food and Drug Administration (FDA). 1

The dangerous side effects of these drugs range from an increased risk of serious and potentially deadly infections to the increased risk of certain types of cancer, 2 particularly non-Hodgkin lymphoma. 3 In November of 2014, researchers at the Mayo Clinic reported finding that TNF inhibitors may increase the risk of a rare form of eye cancer known as uveal melanoma. 4

Additionally, certain TNF inhibitors have been known to be associated with incidence of congestive heart failure, demyelinating disease and tuberculosis. as well as fungal infections. 5

Crohn’s and Colitis: Symptoms and Causes

Crohn’s disease and ulcerative colitis are types of inflammatory bowel disease (IBD). They are chronic autoimmune diseases that affect the digestive tract, often causing severe pain and cramping, continual and persistent diarrhea, and weight loss and debilitating fatigue.

People who suffer from Crohn’s and colitis typically have to follow a careful diet. There are certain foods to avoid with colitis and Crohn’s because they may cause flare-ups. Sometimes the disease can be controlled with medications; other times, surgery may be indicated.

Crohn’s disease is an inflammation of the lining of the digestive tract that can occur anywhere from the mouth to the anus. It typically affects the large or small intestine, but can also occur in the mouth, esophagus, stomach and the anus. 6

Ulcerative colitis typically affects the large intestine and the rectum. The symptoms include ongoing inflammation as well as painful ulcers or sores. 7

Both diseases can affect sufferers in different ways at different times in their lives. There can be periods of remission, when you are virtually symptom free. And there can be periods of flare-up, when you feel the full onslaught of all the symptoms. 8

Both Crohn’s disease and ulcerative colitis are autoimmune diseases. This means that your body’s immune system responds inappropriately. It attacks your own cells as though they were harmful bacteria or pathogens. 9 This is what causes colitis and Crohn’s pain and other symptoms associated with the diseases.

TNF Inhibitors Suppress Your Immune System

TNF inhibitors are part of a class of drugs known as biologics. TNF inhibitors suppress your immune system, specifically, a protein known as TNF-alpha that is found naturally in the body. 10

Researchers believe that overproduction of TNF-alpha is a potential cause of the excessive immune system response that is responsible for Crohn’s and colitis. By neutralizing TNF-alpha, the medication prevents your body’s autoimmune system from mistakenly attacking its own cells.

Of course, because biologics suppress the immune system, they carry the inherent risk of increasing your susceptibility to infection. 11

TNF inhibitor drugs that have indications for Crohn’s disease and ulcerative colitis currently available by prescription include:

  • Remicade (infliximab)
  • Humira (adalimumab)
  • Cimzia (certolizumab)

Side Effects of TNF Inhibitor Drugs for Crohn’s and Colitis

In addition to the recent research that has raised concern about elevated risk of some types of cancer, TNF inhibitors carry other side effects.

Infliximab is given by intravenous drip over the course of several hours. Patients receive multiple, ongoing infusions over time. Besides the elevated risk of cancer and potentially fatal bacterial, viral and fungal infections detailed earlier, infliximab may also cause skin rashes, joint inflammation, changes in blood levels, a lupus-like syndrome, liver problems, nervous system problems, and worsening of pre-existing heart conditions. 12

Adalimumab has approved indications for several autoimmune diseases, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, adult and pediatric Crohn’s disease that has not responded adequately to conventional therapy, ulcerative colitis that has not responded adequately to immunosuppressants, and plaque psoriasis.

Unlike infliximab, adalimumab is administered by injection. It carries many of the same serious side effects as infliximab, with the additional possibility of patients experiencing redness, itching, pain and swelling at the site of the injection. 13

  1. https://open.fda.gov/drug/event/ 

  2. http://www.webmd.com/ibd-crohns-disease/features/cd-evaluating-crohns-treatment 

  3. http://journal.frontiersin.org/Journal/10.3389/fmed.2014.00003/full 

  4. http://www.sciencedaily.com/releases/2014/11/141117130733.htm 

  5. http://informahealthcare.com/doi/abs/10.1080/09546630410017275 

  6. http://www.uchospitals.edu/online-library/content=P00382 

  7. http://www.mayoclinic.org/diseases-conditions/inflammatory-bowel-disease/basics/definition/con-20034908 

  8. http://www.crohnsandcolitis.org.uk/Resources/CrohnsAndColitisUK/Documents/Publications/Booklets/Drugs-Used-in-IBD.pdf 

  9. http://www.ccfa.org/what-are-crohns-and-colitis/ 

  10. http://www.crohnsandcolitis.org.uk/Resources/CrohnsAndColitisUK/Documents/Publications/Booklets/Drugs-Used-in-IBD.pdf 

  11. http://www.webmd.com/ibd-crohns-disease/features/cd-evaluating-crohns-treatment 

  12. http://www.crohnsandcolitis.org.uk/Resources/CrohnsAndColitisUK/Documents/Publications/Booklets/Drugs-Used-in-IBD.pdf 

  13. http://www.crohnsandcolitis.org.uk/Resources/CrohnsAndColitisUK/Documents/Publications/Booklets/Drugs-Used-in-IBD.pdf