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U.S. Department of Health and Human Services

Safety

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Remicade (infliximab) for IV injection

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – November 2009

 

Summary View

 

BOXED WARNING

Malignancy
  • Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including Remicade.

WARNINGS

Malignancies
  • Cases of acute and chronic leukemia have been reported with postmarketing TNF-blocker use in rheumatoid arthritis and other indications. Even in the absence of TNF blocker therapy, patients with rheumatoid arthritis may be at a higher risk (approximately 2-fold) than the general population for the development of leukemia

MEDICATION GUIDE

  • Updated information pertains to the risk of malignancies in pediatric patients, leukemia in adults, and psoriasis-like lesions associated with use of products within the class of TNF-blockers