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FDA Panel Recommends Enbrel for Pediatric Patients

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The FDA review is focusing on the first three. All four are approved for multiple indications.

The drugs have clear benefits, experts said last month, and have revolutionized the treatment of some of these diseases.

"One of the reasons that these medications have such a market despite the concerns is that they are so remarkably effective," Putterman said. "There are not only subjective benefits but a tremendous amount of objective evidence, not only in inflammation and patient symptoms, but also in disease progression. These drugs have really addressed a previously unmet need."

Dr. Stephen Lindsey, head of rheumatology at Ochsner Health Service in Baton Rouge, La., said, "These drugs are probably the most important advance in the treatment of rheumatoid disorders in the last 20 to 30 years. They dramatically improve certain forms of crippling arthritis and almost stop them. Some people go from being in a wheelchair [to] jumping up and walking around."

He added: "They're being used earlier and earlier, because they're so good. I think the FDA is being cautious. I think it's smart. What are the risks of a child being crippled and non-functioning versus the risk of cancer? Maybe, in odd cases, we need to think more and not jump in with all four limbs."

More information

The U.S. Food and Drug Administration has more on TNF blockers.

SOURCES: Chaim Putterman, M.D., chief, division of rheumatology, Montefiore Medical Center and Albert Einstein College of Medicine, New York City; Stephen Lindsey, head, rheumatology, Ochsner Health Service, Baton Rouge, La.;Dow Jones;Wall Street Journal


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