[Documentation and assessment of adverse drug effects with ofloxacin as an example].

A systematical and comprehensive evaluation of all reports on adverse drug reactions ascribed to ofloxacin since this antibiotic was launched (1985) until October 1988 shows that rare and severe adverse drug reactions are more often reported spontaneously than in the course of clinical trials. In particular, severe reductions of white blood cell counts, shock and shock fragments, and impairment of sensory organs and renal functions have for the first time been detected by spontaneous case reports. The results demonstrate exemplarily the potency of the spontaneous reporting system as superior to that of clinical trials in providing information on rare adverse drug reactions.