FDA Warns Remicade May Cause Blood and Nervous System Disorders
The Food and Drug Administration and Johnson & Johnson subsidiary, Centocor, have reported that patients taking the drug Remicade have suffered fatal blood and central nervous system disorders. Centocor spokesman, Craig Buchholz, stated that the FDA has been informed of nearly 600 adverse reactions to the Remicade, more than forty cases involving significant blood disorders, and at least twelve deaths. However, all fatalities reported involved patients taking Remicade in combination with other drugs, and it remains uncertain whether these deaths can be conclusively linked to Remicade use.
Remicade was manufactured by Centocor and approved for use in the United States in August of 1998. The monoclonal antibody was prescribed worldwide to over 500,000 patients suffering from rheumatoid arthritis and Crohn's disease. On August 11th, Centocor released a letter to doctors warning that patients receiving Remicade suffered blood disorders, including reductions in their red and white blood cells and granulocyte and platelet counts. As a result, patients became vulnerable to abnormal blood loss and disease. In rare cases, patients experienced central nervous system disorders that led to the decay of the patients' blood vessels.
Centocor warned physicians to exercise caution when treating patients with histories of significant blood abnormalities with Remicade. Patients with persistent fevers should seek immediate medical attention, while those who have questions or other adverse reactions to report should call Centocor at 1-800-457-6399.