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U.S. Department of Health and Human Services

Safety

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Remicade (infliximab) - Clinical Alert: Congestive Heart Failure

Audience: Rheumatologists, Gastroenterologists and other healthcare professionals

Centocor, in consultation with FDA, is alerting physicians to potential serious adverse effects of REMICADE in patients with CHF. Preliminary results of an ongoing phase 2 trial in patients with moderate to severe CHF demonstrated higher incidences of mortality and hospitalization for worsening heart failure in patients treated with REMICADE, especially those treated with the higher dose of 10 mg/kg. Based on these preliminary findings, and pending additional data, precautionary measures were recommended in a "Dear Healthcare Professional" letter.

[Oct 23, 2001 - Letter - Centocor]