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Phase IV study and post-marketing surveillance of ofloxacin in Japan
M Sawada1, S Nakamura, A Yamada
1Medical Information Department, Daiichi Pharmaceutical Co., Ltd., Tokyo, Japan.
Abstract:
Data derived from phase IV clinical trials of ofloxacin in 13,850 patients show that the incidence of adverse drug reactions was 2.6%. Gastrointestinal symptoms topped other symptoms in order of frequency, followed by neuropsychiatric and hypersensitivity symptoms. On the other hand, we received 155 spontaneous reports on ofloxacin adverse reactions, including severe convulsions and shock. Examination of various cases of adverse drug reactions suggested that both severe renal dysfunction and a predisposition to epilepsy were risk factors contributing to the onset of convulsions, and a predisposition to allergy was also a risk factor in hypersensitivity reactions including shock. Data from phase IV trials aimed at efficacy analysis show a high efficacy rate. The usefulness of ofloxacin was confirmed by the data obtained after its marketing.
Insights
Ofloxacin showed a 2.6% adverse reaction rate in phase IV trials, with gastrointestinal issues most common. The drug demonstrated high efficacy, confirming its usefulness post-marketing.
Area of Science:
- Pharmacovigilance
- Clinical Pharmacology
Background:
- Post-marketing surveillance is crucial for assessing drug safety and efficacy.
- Ofloxacin is a widely used antibiotic requiring ongoing safety evaluation.
Purpose of the Study:
- To evaluate the safety and efficacy of ofloxacin based on phase IV clinical trial data and spontaneous reports.
- To identify risk factors associated with adverse drug reactions to ofloxacin.
Main Methods:
- Analysis of data from 13,850 patients in phase IV clinical trials of ofloxacin.
- Review of 155 spontaneous reports of adverse reactions associated with ofloxacin.
- Correlation of patient factors (renal dysfunction, epilepsy predisposition, allergy predisposition) with adverse events.
Main Results:
- The overall incidence of adverse drug reactions (ADRs) was 2.6%.
- Gastrointestinal symptoms were the most frequent ADRs, followed by neuropsychiatric and hypersensitivity reactions.
- Severe adverse events, including convulsions and shock, were reported; renal dysfunction, epilepsy, and allergy predispositions were identified as risk factors.
Conclusions:
- Ofloxacin exhibits a favorable efficacy profile, as confirmed by phase IV trial data.
- While generally safe, specific patient risk factors necessitate careful consideration to mitigate potential severe adverse reactions like convulsions and shock.