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.

Tuberculosis and other serious opportunistic infections including histoplasmosis, listeriosis, and pneumocystosis have been reported in both clinical research and post-marketing surveillance. Some of the infections have been fatal. Accordingly a boxed warning has been added to the labelling for the product.

Between 24 August 1998 and 30 June 2001, 84 cases of tuberculosis were reported worldwide, with 14 cases of death. Most cases of tuberculosis were diagnosed within seven months of initiation of infliximab therapy and most reported use of concomitant immunosuppressive medications. An increased risk of infections associated with tumour necrosis factor (TNF) blockade, is consistent with the known effects of TNF on macrophage activation and granuloma formation. Thus far, approximately 170,000 patients have been treated worldwide with infliximab.

Patients should be evaluated for latent tuberculosis infection with a tuberculin skin test and treatment of latent tuberculosis infection should be initiated prior to therapy with infliximab. For patients who have resided in regions where histoplasmos is endemic, the benefits and risks of infliximab treatment should be carefully considered before initiating therapy.

Reference: Letter from Centocor, dated 5 October 2001. http://www.fda.gov/medwatch