New Remicade Warning.
Arthritis, Crohn's Disease Drug Linked to Rare but Deadly Liver Failure
Dec. 23, 2004 -- Remicade is linked to rare but sometimes deadly liver reactions, drug maker Centocor and the FDA announced Wednesday.
Remicade is approved to treat rheumatoid arthritis and Crohn's disease.
In a "Dear Healthcare Professional" letter, Centocor is warning doctors that patients treated with Remicade have developed acute liver failure and other liver problems, including jaundice.
Some patients died or required liver transplants to save their lives. The liver reactions occurred two weeks to more than a year after Remicade treatment. Lab tests for abnormal liver enzymes -- a standard test for liver trouble -- did not always predict these liver reactions.
These events appear to be quite rare. They've been reported in three patients before Remicade approval, and in 35 patients worldwide since the drug has been approved. In that time, some 576,000 patients have been treated with Remicade.
Remicade works by suppressing the immune system. That's helpful to patients whose overactive immune reactions underlie their rheumatoid arthritis, Crohn's disease, or ankylosing spondylitis. But it can also be a problem. Remicade treatment has been previously linked to serious infections including tuberculosis. Some of these infections have been fatal.
The Centocor letter also notes that a warning about risk of pneumonia has been added to the Remicade label.
Liver Failure Symptoms
Patients taking Remicade should be aware of symptoms of liver damage or failure, which include: