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Centocor has alerted health care professionals to new safety information regarding infliximab (Remicade), its drug approved for the treatment of rheumatoid arthritis and Crohn’s disease. In a suspended Phase II trial involving 150 patients with moderate-to-severe congestive heart failure (CHF), higher incidences of mortality and hospitalization for worsening heart failure were seen in patients treated with Remicade, especially those treated with the higher dose of 10 mg/kg. Seven of 101 patients treated with Remicade died compared to no deaths among the 49 patients on placebo.
In consultation with the Food and Drug Administration, Centocor mailed a "Dear Doctor" letter communicating these preliminary results to health care professionals nationwide. The letter gives advice about care of patients receiving Remicade who have concomitant CHF. For more information, see www.remicade.com.