Although Remicade has been touted as a miracle product, since its approval, Remicade is a potent product that has been associated with such serious and debilitating side effects. Patients have neither been warned adequately of these risks nor of their severity.

Since its approval, in August of 1998, the warnings regarding using Remicade have changed in response to these serious side effects. In August 15, 2001, a "Black Box Warning" was added to Remicade's label warning that tuberculosis, invasive fungal infections, and other opportunistic infections, have been observed in patients receiving Remicade and that some of these infections have been fatal. Additionally, the following a warning was added to the package insert: Cases of histoplasmosis, listeriosis, pneumocystosis and tuberculosis, have been observed in patients receiving Remicade. 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 therapy."

On October 5, 2001, Centocor sent health care professionals a letter warning them tuberculosis, and other serious opportunistic infections including histoplasmosis, listeriosis, and pneumocystosis, have been reported in both the clinical research and post-marketing surveillance settings. Some of these infections have been fatal. The letter refers the healthcare professional to the August 15, 2001 revisions to the labeling for Remicade including the Black Box Warning. According to the manufacturer, at least 84 cases of tuberculosis had been reported in patients using Remicade.

Less than a week later, on October 18, 2001, a second drug warning was sent to Healthcare Professionals, warning them not to initiate Remicade therapy in patients with congestive heart failure, to discontinue Remicade in patients whose congestive heart failure is worsening and to consider discontinuing Remicade in patients with stable congestive heart failure. Centocor provides in this letter that "Upon review of preliminary results of its ongoing phase 2 trial in 150 patients with moderate to severe (NYHA class III-IV) congestive heart failure (CHF), higher incidences of mortality and hospitalization for worsening heart failure were seen in patients treated with REMICADE, especially those treated with the higher dose of 10 mg/kg. Seven of 101 patients treated with Remicade died compared to no deaths among the 49 patients on placebo.

On January 2002, the FDA, based upon adverse drug reactions reports, issued a warning about serious nervous system problems, involving demyelinization, MS and other conditions, associated with the use of Remicade.
Centocor, currently warns that there are reports of serious infections, including tuberculosis (TB) and sepsis and that some of these infections have been fatal.

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