FDA Adds Liver Failure Warning to Rheumatoid Arthritis Drug

Leflunomide will contain a Boxed Warning about severe liver injury, the Food and Drug Administration said. In 2003 the FDA added cautionary language to the label of the rheumatoid arthritis drug. The information will now appear in a Boxed Warning for the drug, marketed as Arava. It will include information highlighting “the risk of severe liver injury in patients using this drug and how this risk may be reduced,” according to a written statement released by the agency July 13.