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FDA Starts Safety Review of Autoimmune Disorder Drugs
Date:6/4/2008

oved for multiple indications.

TNF blockers work by dampening the immune system, which becomes hyperactive in patients with rheumatoid arthritis.

The drugs have clear benefits, according to experts, 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."

"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," said Dr. Stephen Lindsey, head of rheumatology at Ochsner Health Service in Baton Rouge, La. "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."

The increased risk for cancer may also be a result of factors other than the drug. "The signal [for cancer] has not been a dramatic one," Putterman said. "There are confounding factors in rheumatoid arthritis patients, which can make interpretation of the data more difficult."

One confounding factor is that rheumatoid arthritis patients, independent of treatment, have a higher risk of some cancers, and some patients have also been treated with methotrexate, a chemotherapy agent that has a known association with lymphoma.

And then there's the conflicting scientific evidence. One 2006 study reported that concerns abo
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