Remicade Approved for Ulcerative Colitis in Children

Aged six and older

MONDAY, Sept. 26 (HealthDay News) -- Remicade (infliximab) has been approved by the U.S. Food and Drug Administration to treat moderate-to-severe active episodes of ulcerative colitis in children aged six and older who haven't responded to other therapies.

UC, a form of inflammatory bowel disease, attacks the lining of the large intestine and rectum. Symptoms may include abdominal pain, diarrhea, rectal bleeding, loss of weight and fever. Some 40 percent of the 50,000 to 100,000 children in the United States with inflammatory bowel disease have UC, the FDA said in a news release.

Remicade is a tumor necrosis factor blocker, which suppresses a bodily substance that causes inflammation and plays a role in so-called autoimmune diseases, in which the overactive immune system attacks the body itself.

Remicade has been FDA approved to treat UC in adults and to fight other autoimmune diseases among adults and children, including Crohn's disease, rheumatoid arthritis, plaque psoriasis, psoriatic arthritis and ankylosing spondylitis, the FDA said.

The drug carries a boxed label warning for increased risk of cancer and serious infections including tuberculosis, the agency said. As such, children should have all recommended vaccines before starting Remicade, the FDA said.

Other side effects of Remicade may include worsening of some UC symptoms and headache, the agency said.

Remicade is produced by Janssen Biotech, based in Malvern, Penn.

More information

To learn more about UC, visit Medline Plus.

Scott Roberts

Related Articles

Learn More About Sharp
Sharp HealthCare is San Diego's health care leader with seven hospitals, two medical groups and a health plan. Learn more about our San Diego hospitals, choose a Sharp-affiliated San Diego doctor or browse our comprehensive medical services.

Health News is provided as a service to Sharp Web site users by HealthDay. Sharp HealthCare nor its employees, agents, or contractors, review, control, or take responsibility for the content of these articles. Please read the Terms of Use for more information.