What is Remicade?
Remicade ( Infliximab ) is an immune-suppressing product manufactured by Centocor, a wholly owned subsidiary of Johnson & Johnson, which has been approved by the FDA for the use of treating Crohns' disease and rheumatoid arthritis. Remicade infusions are the only biologic drug indicated for the treatment of both Rheumatoid Arthritis and Crohns disease. Specifically, Remicade infusions, in combination with Methotrexate, is indicated for use in patients with moderately to severely active Crohns disease which have had an inadequate response to conventional therapy and for the treatment of patients with fistulizing Crohns' disease. Since its introduction on August 24, 1998, Remicade infusions have been given to over 230,000 individuals.

Although Remicade has been touted as a miracle drug, it is a potent product and Remicade side effects have been associated with such serious and debilitating problems as tuberculosis, histoplasmosis, listeria sepsis, invasive fungal infections, lymphoma, pneumocystosis, seizures, multiple sclerosis, lupus, serious infections, heart failure and death. Patients have neither been warned adequately of the Remicade side effects nor their severity.

Since its approval in August of 1998, the Remicade warning regarding Remicade infusions have changed in response to these serious Remicade side effects. In August 15, 2001, a "Black Box Remicade Warning" was added to the Remicade side effects label warning that tuberculosis, invasive fungal infections, and other opportunistic infections, have been observed in patients receiving Remicade infusions and that some of these infections have been fatal. Additionally, the following Remicade warning was added to the package insert: "Cases of histoplasmosis, listeriosis, pneumocystosis, and tuberculosis, have been observed in patients receiving Remicade infusions. For patients who have resided in regions where histoplasmosis is endemic, the benefits and risks of Remicade treatment should be carefully considered before initiation of Remicade infusions".