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"Remicade Ineffective For CHF Popular arthritis drug fails Phase II trial for treatment of congestive heart failure" Centocor, the maker of Remicade, has halted a Phase II clinical trial designed to assess its use for the treatment of congestive heart failure (CHF). Previously FDA-approved for the treatment of rheumatoid arthritis and Crohn's disease, Remicade was being studied with the hope of expanding its indications. Read More…

"Centocor And Johnson & Johnson Faces Congestive Heart Failure Clinical Program On Hold" October 22, 2001, Centocor, Inc. announced today that, following evaluation of the preliminary results of an ongoing Phase II clinical trial, further development of REMICADE(R) (infliximab) for the treatment of patients with advanced congestive heart failure (CHF) has been placed on hold. The results demonstrated no improvement in patients' clinical status and showed higher incidence of mortality and hospitalization for worsening heart failure in REMICADE-treated patients, especially those treated at the higher dose of 10 mg/kg. Read More…

"J&J Halts Heart-Failure Trial of Drug" October 22, 2001, Johnson & Johnson (NYSE:JNJ - news) said on Monday it has halted a trial designed to see if its arthritis drug Remicade can be used to treat congestive heart failure, citing a higher death rate in heart patients given the drug than those taking a placebo. ``The results demonstrated no improvement in patients' clinical status and showed higher incidence of mortality and hospitalization for worsening heart failure in Remicade-treated patients,'' the diversified health care giant said. Read More…

"Centocor Updates REMICADE® (infliximab) Prescribing Information" August 15, 2001, Centocor, Inc., announced today that it is updating the prescribing information for REMICADE® (infliximab), a biologic drug used in the treatment of rheumatoid arthritis (RA) and Crohn's disease. Developed with the U.S. Food and Drug Administration (FDA), the revised label instructs that patients should be evaluated for latent tuberculosis with a tuberculin skin test in reference to current American Thoracic Society/Centers for Disease Control and Prevention guidelines, and that treatment for latent tuberculosis should be initiated prior to therapy with REMICADE. In addition, the revised label strengthens the warnings about the risk of serious infections in general, and has drawn attention to this important safety information through a boxed warning. Read More…

"Important Drug Warning" October 5, 2001, Centocor sends out a "Dear Healthcare Professional" letter warning them of tuberculosis and other opportunistic infections that have been reported in association to Remicade (infliximab) and has led to some fatalities. Centocor's letter is to make physicians aware of the new Boxed Warning that will now appear on Remicade as a result of the 84 cases of tuberculosis, including 14 deaths that were reported from the use of the drug. Read More…

"Important Drug Warning" October 18, 2001, Centocor issues another letter addressed "Dear Healthcare Professional" regarding the new safety information for Remicade (infliximab). The letter is issued after preliminary results of its Phase II trial treating patients with moderate to severe congestive heart failure. Higher instances of mortality and hospitalization for worsening heart failure was seen in patients treated with Remicade, especially with higher doses. After consulting with the FDA, Centocor sent warning letters to about 35,000 physicians. The letter offered doctors the following advice and guidelines:

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