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.
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