Johnson & Johnson has added a new warning to the label for rheumatoid arthritis drug Remicade about blood-related problems that were fatal in some cases, the Food and Drug Administration said in a statement posted on its Web site on Tuesday.
Johnson & Johnson, in a letter to doctors also posted on the FDA Web site, said "the causal relationship" between Remicade and the blood problems "remains unclear."
The company also added warning language about rare cases of neurological problems experienced by patients treated with Remicade, the letter said.
The company advised doctors to be cautious about prescribing Remicade to patients with a history of significant blood abnormalities.
Johnson & Johnson shares gained 18 cents to $57.23 in afternoon trading on the New York Stock Exchange, informs Reuters.
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, writes Seattle Post.
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