Colazal Sanctioned for Pediatric Colitis
Previously approved for adults
WEDNESDAY, Dec. 20, 2006 (HealthDay News) -- The U.S. Food and Drug Administration has approved Colazal (balsalazide disodium) to treat mild-to-moderate ulcerative colitis in people ages 5 to 17. Ulcerative colitis is a form of inflammatory bowel disease, causing inflammation of the colon and rectum. It affects about 5 in 100,000 children and teens in the United States each year, the agency said.
The drug was first approved for adults with the same condition in 2000. Its safety and effectiveness in children and teens was evaluated in a multicenter study involving 68 people. Some 45 percent of those who received 6.75 grams of the drug per day for eight weeks showed improvement in symptoms, including rectal bleeding, the FDA said in a statement.
Common adverse side effects reported during the pediatric study included headache, abdominal pain, vomiting and diarrhea.
Colazal is manufactured by Salix Pharmaceuticals Inc. of Morrisville, N.C.
To learn more about ulcerative colitis, visit the National Digestive Diseases Information Clearinghouse.