Journal Article

Safety of Long-Term Therapy with Ciprofloxacin: Data Analysis of Controlled Clinical Trials and Review

S. Segev, I. Yaniv, D. Haverstock and H. Reinhart

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 28, issue 2, pages 299-308
Published in print February 1999 | ISSN: 1058-4838
Published online February 1999 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/515132
Safety of Long-Term Therapy with Ciprofloxacin: Data Analysis of Controlled Clinical Trials and Review

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We reviewed the literature and the manufacturer's U.S. clinical data pool for safety data on long-term administration of ciprofloxacin (Bayer, West Haven, CT). Only controlled clinical trials including patients treated for >30 days were selected. We identified 636 patients by literature search and 413 patients in the Bayer U.S. database who fulfilled our search criteria; the average treatment duration for these patients was 130 and 80 days, respectively. Main indications for long-term therapy were osteomyelitis, skin and soft-tissue infection, prophylaxis for urinary tract infection, mycobacterial infections, and inflammatory bowel disease. Adverse events, premature discontinuation of therapy, and deaths occurred at a similar frequency in both treatment arms. Most adverse events occurred early during therapy with little increase in frequency over time. As with short-term therapy, gastrointestinal events were more frequent than central nervous system or skin reactions, but pseudomembranous colitis was not observed. No previously unknown adverse events were noted. We conclude that ciprofloxacin is tolerated as well as other antibiotics when extended courses of therapy are required.

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Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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