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

For children and adults taking TNF blockers, including REMICADE®, the chances of getting lymphoma or other cancers may increase.

Patients should discuss any concerns about their health and medical care with their doctor.

Patients should let their doctors know if they have or ever had any of the following:

• Tuberculosis (TB) or have been near someone who has TB. Your doctor will check you for TB with a skin test. If you have latent (inactive) TB, you will begin TB treatment before you start REMICADE®.

• Lived in a region where certain fungal infections like histoplasmosis or coccidioidomycosis are common.

• Infections that keep coming back, have diabetes or an immune system problem.

• Any type of cancer or a risk factor for developing cancer, for example, chronic obstructive pulmonary disease (COPD) or had phototherapy for psoriasis.

• Heart failure or any heart condition. Many people with heart failure should not take REMICADE®.

• Hepatitis B virus (HBV) infection or think you may be a carrier of HBV.

• Nervous system disorders (like multiple sclerosis or Guillain-Barre syndrome).

Also tell your doctor about any medications you are taking, including vaccines or Kineret (anakinra), and if you are pregnant, plan to become pregnant or are nursing. Adults and children should not receive a live vaccine while taking REMICADE®.

The following serious (sometimes fatal) side effects have been reported in people taking REMICADE.

Patients should tell their doctors right away if you have any of the signs listed below:

• Infections (like TB, blood infections, pneumonia)—fever, tiredness, cough, flu, or warm, red or painful skin or any open sores. REMICADE® can make you more likely to get an infection or make any infection that you have worse.

• Lymphoma, or any other cancers in adults and children.
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SOURCE Centocor Ortho Biotech Inc.
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