United States of America - The manufacturer of infliximab (Remicade®) has issued a warning concerning new safety information. Infliximab is a biological therapeutic product indicated for the treatment of rheumatoid arthritis and Crohn disease.

Following a recent clinical trial in 150 patients with moderate to severe congestive heart failure, higher incidences of mortality and hospitalization for worsening heart failure were seen in patients treated with infliximab, especially those treated with the higher dose of 10 mg/kg. Seven of 101 patients treated with infliximab died compared to no deaths among the 49 patients on placebo. In this trial, stable but symptomatic patients with moderate to severe congestive heart failure were treated with 3 infusions of infliximab - 5 mg/kg, 10 mg/kg or placebo, over 6 weeks.

For patients with rheumatoid arthritis or Crohn disease being considered for therapy with infliximab, do not initiate therapy in patients with congestive heart failure.

Patients with congestive heart failure currently receiving chronic infliximab treatment for rheumatoid arthritis or Crohn disease should be re-evaluated. Treatment should be discontinued in patients whose congestive heart failure is worsening; treatment discontinuation should be considered in patients with stable concomitant congestive heart failure.

Reference: Letter from Centoco, dated 18 October 2001. http://www.fda.gov/medwatch