Global safety of etodolac: reports from worldwide postmarketing surveillance studies.
Etodolac is a new nonsteroidal anti-inflammatory drug (NSAID) that has shown a favorable safety profile in clinical trials in osteoarthritis (OA) and rheumatoid arthritis (RA). Four postmarketing surveillance studies were conducted with patients who had OA and RA to further assess the safety of etodolac. One study also had patients with ankylosing spondylitis (AKS). These studies were conducted in Italy, Switzerland, the United Kingdom, and France. A total of 8334 patients received oral doses of 200 to 600 mg/day for periods ranging from 4 weeks to 1 year. The incidence of study events was low, 77% of the patients treated in these postmarketing surveillance studies reported no study events. Only 9% of all the patients treated withdrew from these studies because of adverse effects. Gastrointestinal events were the most commonly reported among the study events that did occur, as expected for an NSAID. These results further support the safety of etodolac that was previously established in clinical trials.
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Primario Reumatologo, Istituto Ortopedico Toscano, Firenza, Italy.
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects / Q000592:standards* / Q000627:therapeutic use; D001172:Arthritis, Rheumatoid / Q000188:drug therapy / Q000453:epidemiology; D017308:Etodolac; D005260:Female; D005602:France / Q000453:epidemiology; D006801:Humans; D007210:Indoleacetic Acids / Q000008:administration & dosage / Q000009:adverse effects / Q000592:standards* / Q000627:therapeutic use; D007558:Italy / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D010003:Osteoarthritis / Q000188:drug therapy / Q000453:epidemiology; D011358:Product Surveillance, Postmarketing; D013557:Switzerland / Q000453:epidemiology; D014456:Ulcer / Q000139:chemically induced; D006113:United Kingdom / Q000453:epidemiology
D000894:Anti-Inflammatory Agents, Non-Steroidal; D007210:Indoleacetic Acids; D017308:Etodolac