Remicade: More Approvals, More Warnings

December 22, 2004 A new safety warning addressing rare, severe hepatic reactions was added to the label of Remicade, a product of Johnson & Johnson's Centocor division. At the same time, J&J announced that the FDA approved Remicade for Ankylosing Spondylitis (SA), a rare but severe disease that strikes young people and leads to stiffening of the spine and disability. The drug is already approved for Crohn's disease and rheumatoid arthritis. Although the new patient population is small, we think this new approval is important...