Safety of long-term therapy with ciprofloxacin: Data analysis of controlled clinical trials and review

We reviewed the literature and the manufacturer's U.S, clinical data pool f or safety data on long-term administration of ciprofloxacin (Bayer, West Ha ven, CT). Only controlled clinical trials including patients treated for >3 0 days were selected. We identified 636 patients by literature search and 4 13 patients in the Bayer U.S. database who fulfilled our search criteria; t he average treatment duration for these patients was 130 and 80 days, respe ctively. Main indications for long-term therapy were osteomyelitis, skin an d soft-tissue infection, prophylaxis for urinary tract infection, mycobacte rial infections, and inflammatory bowel disease. Adverse events, premature discontinuation of therapy, and deaths occurred at a similar frequency in b oth treatment arms. Most adverse events occurred early during therapy with little increase in frequency over time. As with short-term therapy, gastroi ntestinal events were more frequent than central nervous system or skin rea ctions, but pseudomembranous colitis was not observed. No previously unknow n adverse events were noted. We conclude that ciprofloxacin is tolerated as well as other antibiotics when extended courses of therapy are required.