FDA Issues New Warnings for Remicade
Drug for Rheumatoid Arthritis, Crohn's Disease Linked to Blood and Nervous System Disorders
Aug. 25, 2004 -- The FDA is warning doctors that people using the drug Remicade may face an increased risk of potentially fatal blood or nervous system disorders.
Remicade was approved for the treatment of Crohn's disease in 1998 and for rheumatoid arthritis in 2000. Since then, the manufacturer, Centocor, says it has learned of several reports of blood and nervous system disorders, including some fatal cases, in people taking the drug.
In a warning letter sent to health care providers earlier this month, the company said some Remicade users suffered from a loss of infection-fighting white blood cells, oxygen-carrying red blood cells, and blood-clotting platelets that left them vulnerable to infection or abnormal bleeding, and some of them died. Centocor says, however, that the association between taking the drug and these disorders remains unclear.
The company also warned of rare cases of central nervous system disorders, such as inflammation of the blood vessels, that have been reported in Remicade users.
In response, Centocor and the FDA have revised the warnings and adverse reactions sections of the labeling for Remicade to include information on these possible risks.
What to Do
Officials say people using Remicade should seek immediate medical attention if they develop symptoms of blood disorders or infection while using the drug, such as:
Remicade users are also advised to tell their doctor if they have a disease that affects the nervous system, or if they develop any of the following symptoms:
- Visual disturbances