Evaluation of the safety of isoxicam

Abstract Data collected from more than 1,800 patients with rheumatoid arthritis or degenerative joint disease in Phase 3 clinical studies of isoxicam (Maxicam) indicated that the drug is well tolerated on both a short-term and a long-term basis. The most common type of adverse reaction to all medications (isoxicam, aspirin, and indomethacin) was gastrointestinal: 22.6 percent with isoxicam, at a dosage greater than 200 mg per day; 14.2 percent with isoxicam at 200 mg per day; 31.6 percent with buffered aspirin at 3,600 to 4,800 mg per day; 24.6 percent with indomethacin at 150 mg per day; and 7.2 percent with placebo. The incidence of tinnitus and deafness was significantly greater with buffered aspirin than with isoxicam, and the number of patients who had at least one episode of dizziness, vertigo, or headache was significantly greater with indomethacin than with isoxicam. In open-label, long-term studies, in which approximately 70 percent of the patients participated, the types and frequencies of adverse effects were similar to those observed with isoxicam during the controlled studies. The overall frequency of withdrawal for adverse reactions during the long-term studies was 11.5 percent, similar to that during the controlled studies. At the recommended dosage for isoxicam of 200 mg per day, the incidence of gastrointestinal ulcers was 0.81 percent, well within the range expected among arthritic patients receiving nonsteroidal anti-inflammatory drugs. From the data collected in Phase 3 clinical studies, it may be concluded that isoxicam is better tolerated than either aspirin or indomethacin and should not create unusual problems in the short-term or long-term treatment of rheumatoid arthritis or degenerative joint disease.