New Remicade Warning: Arthritis, Crohn's Disease Drug Linked to Rare but Deadly Liver Failure

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New Remicade Warning:

Arthritis, Crohn's Disease Drug Linked to Rare but Deadly Liver Failure

http://my.webmd.com/content/article/98/104980.htm

SOURCES: FDA. WebMD Medical Reference in collaboration with The

Cleveland Clinic: 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:

* Nausea

* Loss of appetite

* Fatigue

* Diarrhea

* Jaundice