http://www.intelihealth.com/IH/ihtIH/EMIHC000/333/9247/331301.html

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.

-- suzy (Itssuzy2@aol.com), August 17, 2001