FDA approves Infliximab for Treatment of Pediatric Ulcerative Colitis

Ulcerative Colitis

(UC) is essentially a component of the inflammatory bowel disease. UC and Crohn’s disease account for majority of the disorders related to Inflammatory Bowel Disease. The discussed condition is characterized by an inflammation of the large intestine which includes the colon. UC also includes tears developing into ulcers on the mucus lining of the colon.

This condition is known to affect children and young adults apart from adults. About 20-25% of all cases of UC occur in individuals below 20 years of age.

The latest news is that the United States Food and Drug Administration (FDA) has approved the drug Infliximab (Remicade, Janssen Biotech) to be used for the treatment of UC in children above 6 years of age. This is especially useful for children who have not responded to traditional treatment.

The drug Infliximab is actually a Tumor Necrosis Factor (TNF)-α blocker and helps to maintain a status quo with the symptoms of pediatric

ulcerative colitis

. The disappearance of the symptoms or the clinical remission is maintained with the drug. The immune system is suppressed and the TNF is blocked. TNF is the main culprit behind this autoimmune condition causing inflammation and ulceration of the colon.

The drug was previously used on adults to treat UC, Crohn’s disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis etc.

However, there were always concerns on approving the use of the drug on children below 6 years. There were a lot of issues about the safety of its use on children. There were a lot of doubts whether the drug would be suitable for long term use in children.

The drug comes with a statutory warning of serious side effects like cancer and infections. The adverse reactions of the drug would be worsening of the

ulcerative colitis

, upper respiratory tract infection, headache etc.

The FDA Center for Drug Evaluation and Research director, Donna Griebel, still voiced the safety concerns associated with the use of Infliximab in children. She harped on the need of the patient’s family being informed about the risks associated with the use of Infliximab.
The FDA also emphasized on the need of the children being up-to-date with age specific mandatory vaccinations before getting started on Infliximab. Children should not receive any vaccines while on the drug for fear of drug interference.

Never the less, it is an extremely important breakthrough as far as the treatment options for UC in children are concerned.


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