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FDA Advisory Committee Recommends Approval of REMICADE® for Treatment of Pediatric Ulcerative Colitis
Date:7/21/2011

eath, swelling of your ankles or feet, or sudden weight gain.
  • Reactivation of HBV — feeling unwell, poor appetite, tiredness, fever, skin rash and/or joint pain.
  • Liver injury — jaundice (yellow skin and eyes), dark brown urine, right-sided abdominal pain, fever, or severe tiredness.
  • Blood disorders — fever that doesn't go away, bruising, bleeding or severe paleness.
  • Nervous system disorders — numbness, weakness, tingling, changes in your vision or seizures.
  • Allergic reactions during or after the infusion — hives, difficulty breathing, chest pain, high or low blood pressure, swelling of face and hands, and fever or chills.
  • Lupus-like syndrome — chest discomfort or pain that does not go away, shortness of breath, joint pain, rash on the cheeks or arms that gets worse in the sun.  The more common side effects with REMICADE® are respiratory infections (that may include sinus infections and sore throat), headache, rash, coughing and stomach pain.
  • Psoriasis — new or worsening psoriasis such as red scaly patches or raised bumps on the skin that are filled with pus.  

  • Please read important information about REMICADE®, including full U.S. prescribing information and Medication Guide, at www.remicade.com.

    About Janssen Biotech, Inc.

    Janssen Biotech, Inc. redefines the standard of care in immunology, oncology, urology and nephrology. Built upon a rich legacy of innovative firsts, Janssen Biotech, Inc. has delivered on the promise of new treatments and ways to improve the health of individuals with serious disease.  Beyond its innovative medicines, Janssen Biotech, Inc. is at the forefront of developing education and public policy initiatives to ensure patients and their families, caregivers, advocates, and health care professionals have access to the latest treatment infor
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    SOURCE Janssen Biotech, Inc.
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