FDA Approves Drug for Pediatric Colitis

By Nadine Salmon, BSN, IBCLC, Clinical Content Specialist AMN Healthcare

In September 2011, the U.S. Food and Drug Administration (FDA) approved Remicade (infliximab) to treat moderate to severe active ulcerative colitis (UC) in children 6 years and older, who have had inadequate response to conventional therapy (FDA, 2011). With this approval, there is new hope for children with active ulcerative colitis who have not had an adequate response to conventional treatment, although there can be some serious risks associated with the use of this drug.

UC is a type of inflammatory bowel disease (IBD) that affects the lining of the large intestine and rectum. Symptoms of UC include abdominal pain, diarrhea, rectal bleeding, weight loss and fever. Between 50,000 and 100,000 children in the United States have IBD; of these, 40 percent have UC (FDA, 2011). Remicade reduces the signs and symptoms of UC and induces and maintains clinical remission in these patients.

Remicade is a tumor necrosis factor (TNF) blocker, which suppresses a substance in the body that causes inflammation in autoimmune diseases. TNF blockers suppress the immune system by blocking the activity of TNF. In addition to being approved for UC, Remicade is approved for the treatment of other autoimmune diseases such as Crohn’s disease in adults and children 6 years and older, as well as rheumatoid arthritis, ankylosing spondylitis (arthritis affecting the joints in the spine and the pelvis), psoriatic arthritis (joint pain associated with psoriasis), and plaque psoriasis in adults (FDA, 2011).

Remicade carries a boxed warning (the sternest warning the FDA can apply to pharmaceuticals) for risk of serious infection and an increased risk of some cancers (FDA, 2011). Increased risk of infection may include tuberculosis and/or infections caused by viruses, fungi or bacteria. There have been cases of unusual cancers reported in adolescent and young adult patients using TNF-blocking agents, including a rare and fatal type of cancer called hepatosplenic T-cell lymphoma.

Patients and their families should always discuss medication risks and benefits with their physician before deciding to start treatment. Families should also be educated to ensure that all immunizations are brought up-to-date prior to commencing therapy with Remicade, and children should not receive live vaccines while taking Remicade. 

The most common side effects of Remicade are worsening of UC, upper respiratory infections, infusion-related reactions, and headache.

For more information, visit the FDA website.


FDA, (2011). Press Announcement: FDA Approves Remicade to Treat Ulcerative Colitis in Children 6 Years and Older. Retrieved from: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm272997.htm