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Article on Remicade and TB testing

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Know we were discussing the use of Remicade at one time... Thought this was

interesting... Lu was it your dr who wanted to put you on this?

TB Test Required For Arthritis Patients Wishing To Take Remicade

August 16, 2001

WASHINGTON (AP) - Rheumatoid arthritis patients must be tested for

tuberculosis before they begin taking a treatment called Remicade, the drug

maker and the government announced.

Patients using Remicade are at least four times more likely than average

Americans to get active tuberculosis, the Food and Drug Administration

estimates. The problem: Apparently the drug suppresses users' immune systems

enough that if they unknowingly carry the TB germ, the respiratory illness

can suddenly flare up.

The warning is serious because untreated, TB can kill - and it's also an

airborne illness that these patients could spread to family and friends.

Worldwide, 88 cases of tuberculosis have been reported among the estimated

170,000 people who have tried Remicade, FDA's Dr. Bill Schwieterman said

Wednesday. Fifteen of those people died.

Some 2 billion people worldwide are infected with TB and risk developing an

active case of the disease. In the United States, TB cases dropped to a

record low of 16,377 last year. But the illness is a continuing threat here,

with increased foreign travel and immigration from countries where TB is

common.

Rheumatoid arthritis afflicts more than 2 million Americans when their immune

systems go awry and attack their joints, causing severe swelling, pain and

stiffness.

Remicade is a bioengineered drug that roams patients' blood to sop up an

immune system protein called tumor necrosis, a factor responsible for much of

the swelling.

But that immune suppression, so important in fighting rheumatoid arthritis,

can leave users at a higher risk for serious infections. Remicade's label has

long carried warnings about various infections, but it now will carry a boxed

warning in bold type about the TB risk - the strongest warning possible for a

prescription drug.

The warning doesn't say people should stop using Remicade. The risk of

activating latent TB appears highest in the first three to six months of use,

so doctors should carefully evaluate those patients, Schwieterman said.

But before prescribing Remicade to a first-time user, doctors should test for

TB - it's a simple skin test - and treat TB carriers, the FDA concluded.

Manufacturer Centocor Inc. will send letters to thousands of doctors who

prescribe Remicade, both for rheumatoid arthritis and the bowel ailment

ailment Crohn's disease, alerting them to the warning.

A similar rheumatoid arthritis treatment called Enbrel also suppresses the

immune system and carries warnings that users face the risk of serious

infections. But so far, Enbrel users don't seem to face a special TB risk,

Schwieterman said.

Copyright 2001 The Associated Press. All rights reserved.

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