The FDA has identified 49 cases of severe liver injury -- 14 of which proved fatal -- in patients taking the rheumatoid arthritis drug leflunomide, which is marketed as Arava. The agency said in a July 13 safety announcement that it has responded by adding information about severe liver injury to the boxed warning of the product's package label.
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FDA Adds Information on Severe Liver Injury to Leflunomide's Boxed Warning
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