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Warnings Issued for Remicade (Infliximab)used For Rheumatoid Arthritis and Crohn's

 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. 

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 as tuberculosis, histoplasmosis, listeria sepsis, invasive fungal infections, lymphoma, pneumocystosis, seizures, multiple sclerosis, lupus, serious infections, and heart failure, and death. Patients have neither been warned adequately of these risks nor of their severity. 

Black Box Warning Added
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. 

Second Warning Issued
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.

In 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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[1] Jon L. Gelman, who practices in Wayne, NJ, wrote Workers’ Compensation Law (West Group 2003), is a contributing member/author of the advisory board of Modern Workers Compensation (West Group 2001) & is a former national Vice-President of the Workplace Injury Litigation Group. Jon L. Gelman, 1700 State Route 23 Suite 120, Wayne, NJ 07470-7537, Voice: 973.696.7900, Fax: 973.696.7988, e-mail: jon@gelmans.com, Internet: www.gelmans.com.

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