Arthritis Drug Arava is approved by FDA

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About 2 million Americans with rheumatoid arthritis gained the first new treatment against their crippling disease in more than a decade yesterday, a drug that promises to relieve their pain and stiffness and slow the erosion of their joints.

Arava, made by Hoechst Marion Roussel, is not a cure. But the Food and Drug Administration approved Arava yesterday as comparable to today’s standard therapy, methotrexate, giving patients a long-needed alternative.

In addition, doctors say studying Arava has brought new understanding in how to treat rheumatoid arthritis — that patients need powerful therapy in the disease’s earliest stages to help protect joints from irreparable damage.

The studies suggest taking either methotrexate or Arava is important for patients in the first one to three years of their disease when their joints are undergoing a silent, serious attack, said Dr. Michael Schiff of the Denver Arthritis Center.

Yet many early rheumatoid patients take only anti-inflammatory painkillers.

But Arava must be used carefully by women of childbearing age, the FDA warned. Those women must use effective birth control while taking Arava because animal studies suggest the drug can cause numerous birth defects.

Like methotrexate, Arava can cause diarrhea, hair loss and liver toxicity. Arava patients will need regular liver monitoring, but any toxicity typically occurs soon after patients begin taking the drug.

Rheumatoid arthritis is not the type that plagues the elderly as their joints wear out. It is an autoimmune disease — the immune system goes awry and attacks patients’ own cartilage. It typically strikes between ages 25 and 50, and afflicts mostly women.

Sources: Life Extension Foundation, Associated Press

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