Remicade Basics

Remicade (Infliximab) is an immune-suppressing product manufactured by Centocor, a wholly owned subsidiary of Johnson & Johnson, which has been approved by the U.S. Food and Drug Administration for the use for Crohn's disease and rheumatoid arthritis. Remicade is a worldwide market share leader among tumor necrosis factor alpha therapies and is the only biologic drug indicated for the treatment of both Rheumatoid Arthritis and Crohns' disease. Specifically, Remicade, in combination with methotrexate, is indicated for use in patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to methotrexate alone. It is also approved in patients with moderately to severely active Crohn's disease which have had an inadequate response to conventional therapy and for the treatment of patients with fistulizing Crohn's disease. Since its introduction on August 24, 1998, Remicade has been prescribed to over 230,000 individuals.

Remicade, administered through intravenous infusion, currently, is the only biologic drug approved for these two conditions. As such, Remicade's manufacturer, Centocor, Inc., a wholly owned subsidiary of Johnson & Johnson, has greatly profited from its production. Remicade has been associated with potentially fatal infections, including tuberculosis, histoplasmosis, listeriosis, and pneumocystosis. Furthermore, the FDA recently warned that Remicade use by patients suffering from congestive heart failure may be dangerous.


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What does it do?

As mentioned, Remicade the only drug approved for the treatment of both rheumatoid arthritis and Crohn's disease and is available as an intravenous product. Remicade reduces inflammation in the body by targeting and binding to tumor necrosis factor alpha which produces inflammation. For rheumatoid arthritis treatment, Remicade is to be used in combination with methotrexate, a standard treatment for rheumatoid arthritis, and this combination is administered six to eight times per year. For Crohn's disease treatment, Remicade is used on a more short term basis.

Remicade works by inhibiting the tumor necrosis factor (TNF) production by binding the TNF cell receptors and blocking interaction. Although TNF serves as a means of defense against various diseases, research shows that rheumatoid arthritis and Crohn's disease are caused by TNF. Remicade inhibits the TNF, and as a result thereof, the body loses its immunity against certain other diseases and symptoms. The drug, thus, allows potentially fatal side effects.

Remicade's first obtained FDA approval in 1998. Since this initial approval, the manufacturer has issued numerous warning and label updates.

In August 2001, Centocor, Inc. adding a warning to Remicade's label identifying an increased risk of developing tuberculosis. Remicade has been linked to a reported seventy cases of tuberculosis, four of which have been fatal. Remicade is now marketed with a "black box" warning which reads:

WARNING RISK OF INFECTIONS: Tuberculosis (frequently disseminated or extrapulmonary at clinical presentation), invasive fungal infections, and other opportunistic infections, have been observed in patients receiving REMICADE. Some of these infections have been fatal (see WARNINGS). Patients should be evaluated for latent tuberculosis infection with a tuberculin skin test. Treatment of latent tuberculosis infection should be initiated prior to therapy with Remicade.

Remicade has also been linked to the deaths of congestive heart failure patients. On October 18, 2001, Centocor, Inc. issued an "Important Drug Warning" which announced that seven of one hundred one patients treated with Remicade had died during ongoing testing, compared to zero deaths among 49 test patients not using Remicade. The following day, the Food and Drug Administration revealed Remicade's potentially negative effects on patients with congestive heart failure. Subsequently, a detailed statement was issued to physicians describing the reasons for the warning and recommended treatment changes for patients with congestive heart failure taking the drug. According to the Centocor, Inc. it was determined that patients with moderate to severe congestive heart failure were at higher risk of death or worsening of their condition while taking Remicade. For congestive heart failure patients with Crohn's disease or rheumatoid arthritis, Centocor, Inc. advised against initiating any Remicade therapy.