An analysis of worldwide safety experience with auranofin.

A total of 3,475 patients with rheumatoid arthritis have received auranofin (AF) during clinical trials in 27 countries. Over a 4-year period, treatment with AF was relatively well tolerated. Most reactions were mild, easily managed and occurred during the first few months of treatment. Gastrointestinal side effects were the most common problems reported with AF followed by mucocutaneous reactions. Less frequently observed were conjunctivitis, proteinuria and, rarely, thrombocytopenia. The percentage of patients withdrawn for adverse effects per patient-year was less with AF when compared to injectable gold (14 vs 40%). These results confirm previous reports of AF safety and improved tolerance versus parenteral gold.