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
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
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,
To learn more about UC, visit