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Centocor Ortho Biotech Inc. Submits Application to FDA Seeking REMICADE® Pediatric Ulcerative Colitis Indication
Date:12/29/2010

 

• Heart failure—new or worsening symptoms, such as shortness of breath, 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 Centocor Ortho Biotech Inc.

Centocor Ortho Biotech Inc. redefines the standard of care in immunology, nephrology, and oncology. Built upon a pioneering history, Centocor Ortho Biotech Inc. harnesses innovations in large-molecule and small-molecule research to create important new therapeutic options. Beyond its innovative medicines, Centocor Ortho Biotech is at the forefront of developing education and public policy initiatives to ensure patients and their fami
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SOURCE Centocor Ortho Biotech Inc.
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