In August of 1998, Remicade was approved for the treatment of Crohn’s disease. In November of 1999, the FDA approved Remicade to treat rheumatoid arthritis. Over 150,000 people worldwide have taken Remicade, made by Johnson & Johnson's Centocor unit. Remicade controls the pain associated with rheumatoid arthritis, the chronic inflammation in the lining of the joints and the pain from Crohn's disease, an intestinal disease. Known generically as Infliximab, Remicade is an immune-suppressing drug.
The concerns for Remicade side effects, including Tuberculosis arose from a study conducted by researchers from the FDA, published in the New England Journal of Medicine. Their study, published in the Oct. 11, 2001 issue, found that from August 1998 to May 2000, 70 people treated with Remicade developed Tuberculosis (TB), and four of those patients died as a result. The report explains that TB cases occur in arthritis sufferers at an annual rate of approximately 6.2 cases per 100,000. However, for patients taking Remicade the rate was 24.4 per 100,000, the researchers said.
The results of the Remicade study suggest that taking the drug
nearly quadruples the risk of developing tuberculosis. Since the
study, the FDA has issued a series of warnings and now requires
the drug to carry a special "black box warning" on its label, warning
of the risk of tuberculosis. The revised labeling indicates that
patients should be tested and treated for latent (inactive), TB prior
to infliximab therapy, so that the immune-suppressing medication
will not increase the tuberculosis risk.
Symptoms of Tuberculosis include severe cough, chest pain,
night sweats, chills, weight loss, fever, fatigue and weight loss.
