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FDA Approves Remicade to Treat Ulcerative Colitis in Children Older Than 6 Years
Date:9/23/2011

s (joint pain associated with psoriasis), and plaque psoriasis in adults.

The safety and efficacy of Remicade was supported by a multi-center, randomized, open-label study in 60 children ages 6 years to 17 years with moderately to severely active UC. All had failed to respond to or tolerate conventional treatment.

Remicade carries a Boxed Warning for risk of serious infections and cancer. Increased risks of infections include tuberculosis and 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.

Children should have all of their vaccines brought up to date before starting treatment with Remicade and 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.  

Remicade is manufactured by Janssen Biotech Inc. in Malvern, Pa.

For more information:

Information on Tumor Necrosis Factor (TNF) Blockers
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109340.htm

Approved Drugs: Questions and Answers
http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm054420.htm

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products tha
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SOURCE U.S. Food and Drug Administration
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