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, a subsidiary of health care product manufacturer Johnson & Johnson, said the FDA has been told of 580 adverse reaction reports among 509,000 worldwide patients, said Craig Buchholz, a Centocor spokesman. Forty-four reports were most worrisome because they involved significant blood disorders.
At least 12 patients taking Remicade — in combination with other drugs — died worldwide.
“It was unclear whether these deaths were caused by this product,” said Lenore Gelb, an FDA spokeswoman.
The Malvern, Pa.-based company, working with the federal drug regulatory agency, revised its label for the monoclonal antibody.
Serious side effects reported
The company’s Aug. 11 warning letter to doctors said patients receiving Remicade suffered reductions in their red and white blood cell, granulocyte and platelet counts, leaving them more vulnerable to abnormal bleeding and infections. In rare instances, patients suffered central nervous system disorders, including confusing immune system responses that swelled, then decayed, 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.
Doctors or patients with questions about whether to continue using Remicade, or who have additional adverse reactions to report, should call the company at 1-800-457-6399.
Remicade was approved for use in the United States on Aug. 24, 1998. In late July, a European advisory committee approved expanding its use for treating people with psoriatic arthritis.
In the United States, phase three clinical trials indicated one in three patients taking the drug showed marked improvement in their psoriatic arthritis. Later this year, the company will ask the FDA to expand the drug’s usage, Buchholz said.