
August 17, 2001
Over the past several years, two rheumatoid arthritis drugs have been approved, making successful treatment of painful arthritis symptoms a reality for thousands of patients worldwide. These two drugs, Enbrel and Remicade, act to inhibit tumor necrosis factor (TNF), a cause of arthritic pain.
In August 2001 the Food and Drug Administration's Arthritis Advisory Committee will meet to discuss safety concerns regarding these two TNF inhibitors. The Committee aims to ensure that product labeling adequately reflects the long-term effects seen in many patients using these drugs.
Centocor, Inc., the manufacturer of Remicade, recently announced that it will strengthen Remicade's label to instruct patients on the need for tuberculosis testing before using the drug. The warning comes after studies found 84 cases of tuberculosis in patients using Remicade.
The committee also plans to discuss a newly discovered side effect of these drugs: demyelination. This condition is a type of nerve damage often associated with multiple sclerosis. In addition, the FDA committee will investigate an association between lymphoma and TNF inhibitors. While a connection has yet to be confirmed, rheumatoid arthritis patients seem more prone to develop this form of cancer.
-- Article Courtesy of InjuryBoard.com
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