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New One-Year Data from REMICADE(R) SONIC Trial Show Sustained Efficacy Compared with Azathioprine in Treatment of Crohn's Disease
Date:6/2/2009

ver had any of the following:

  • Tuberculosis (TB) or have been near someone who has TB. Doctors will check for TB with a skin test. If a patient has latent (inactive) TB, TB treatment should begin before starting REMICADE.
  • Lived in a region where certain fungal infections like histoplasmosis or coccidioidomycosis are common.
  • An infection that keeps coming back (or any problems that increase the risk of infection) or have diabetes.
  • 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).

Patients should tell their doctors about any medications they are taking, including vaccines or Kineret (anakinra), and if a woman is pregnant, plans to become pregnant or is 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(R) can make patients more likely to get an infection or make any current infection worse.
  • Lymphoma, or any other cancers. A rare form of fatal lymphoma has occurred mostly in teenage or young adult males with Crohn's disease or ulcerative colitis who were taking REMICADE and azathioprine or 6-mercapto
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SOURCE Centocor Ortho Biotech Inc.
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