The Food and Drug Administration and manufacturer Centocor are warning doctors that patients receiving the drug Remicade to treat rheumatoid arthritis and Crohn's disease have suffered sometimes fatal blood and central nervous system disorders.
Centocor's Aug. 11 warning letter to doctors said the "causal relationship" between the ailments and Remicade therapy "remains unclear."
The Malvern, Pa.-based company, working with the federal drug regulatory agency, revised its label for the monoclonal antibody.
Patients receiving the drug suffered reductions in their red and white blood cell, granulocyte and platelet counts, leaving them more vulnerable to abnormal bleeding and infections. In some instances, patients died. In rare instances, patients suffered central nervous system disorders, including confusing immune system responses that swelled, then decayed, blood vessels.
Remicade was approved for use in the United States on Aug. 24, 1998. Worldwide, 509,000 patients have taken it. In late July, a European advisory committee approved expanding its use for treating people with psoriatic arthritis.