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FDA Approves Azulfidine EN-Tabs (Sulfasalazine) To Treat Rheumatoid Arthritis In Children

  [ 19 votes ]   [ Discuss This Article ]
www.ProHealth.com • October 3, 2000


Children with juvenile rheumatoid arthritis involving five or more diseased joints, can turn to a newly approved drug for treatment. The U.S. Food and Drug Administration (FDA) has approved a new indication for Azulfidine EN-tabs® (sulfasalazine delayed release tablets) in patients who have responded inadequately to salicylates or other nonsteroidal anti-inflammatory drugs (NSAIDs).

Azulfidine EN-tabs is the only formulation of sulfasalazine approved by the FDA for the treatment of both juvenile and adult RA. The enteric-coated formulation of Azulfidine EN-tabs was specifically designed to reduce the likelihood of nausea and stomach upset.

In a randomized, double-blind, placebo-controlled, clinical trial, sulfasalazine was evaluated in children with juvenile rheumatoid arthritis. This 24-week trial showed that sulfasalazine, compared to placebo, significantly reduced several clinical endpoints of joint disease including number and severity of swollen joints, number of active joints and overall joint severity score.

This clinical effectiveness of sulfasalazine was reinforced by significant reduction in disease activity scored by physicians, parents and patients.

"The FDA's approval of Azulfidine EN-tabs for juvenile rheumatoid arthritis gives clinicians in pediatric rheumatology an important new option to effectively manage this condition," said Arthur Weaver, M.D., director of clinical research at The Arthritis Center of Nebraska, and clinical professor at the University of Nebraska Medical Center.

In the treatment of adult RA, sulfasalazine, the active ingredient in Azulfidine EN-tabs, has been classified by the American College of Rheumatology as part of a group of compounds called disease-modifying anti-rheumatic drugs (DMARDs). While it has not been confirmed in children, DMARDs have the potential to reduce or prevent joint damage and preserve joint integrity and function. Rheumatoid Arthritis is a debilitating disease that affects 2.1 million Americans, of which 50,000 are children. The disease causes joint pain, stiffness and swelling in or around joints, as well as joint destruction.

Patients with intestinal or urinary obstructions, porphyria (pigment disorder) or hypersensitivity to sulfasalazine, sulfonamides or salicylates, should not use Azulfidine EN-tabs. The most common adverse reactions (incidence of 5 percent or greater) reported in RA clinical trials with sulfasalazine enteric-coated tablets were nausea, dyspepsia, rash, immunoglobulin suppression, headache, abdominal pain, vomiting and fever.



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