Sulfasalazine delayed-release tablets (Azulfidine EN-tabs) have been approved by the U.S. Food and Drug Administration (FDA) for the treatment of children six through 16 years of age with juvenile rheumatoid arthritis involving five or more diseased joints who have not responded adequately to salicylates or other nonsteroidal anti-inflammatory drugs. The tablets are the only formulation of sulfasalazine approved by the FDA for the treatment of juvenile and adult rheumatoid arthritis.
According to the manufacturer of sulfasalazine, rheumatoid arthritis is a debilitating disease that affects 50,000 children in the United States. The disease causes joint pain, stiffness and swelling in or around joints, and joint destruction.
In clinical trials, sulfasalazine significantly reduced the number and severity of swollen joints, the number of active joints and overall joint severity score. There was also a significant reduction in disease activity scored by physicians, parents and patients.
Sulfasalazine delayed-release tablets are enteric coated to reduce the likelihood of nausea and stomach upset. The most common side effects of sulfasalazine are nausea, dyspepsia, rash, immunoglobulin suppression, headache, abdominal pain, vomiting and fever. Patients who have intestinal or urinary obstructions, porphyria or hypersensitivity to sulfasalazine, sulfonamides or salicylates should not use sulfasalazine delayed-release tablets.
COPYRIGHT 2001 American Academy of Family Physicians
COPYRIGHT 2001 Gale Group