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Pefloxacin: safety in man
Abstract:
Pefloxacin has been in clinical use in France since 1985. During this period of time, the Rhone-Poulenc Drug Safety Department has received 213 spontaneous reports concerning patients who experienced a total of 316 adverse events. The level of such spontaneous reporting from physicians depends upon the frequency and the clinical significance of the events. Skin, musculoskeletal and CNS problems were the events most frequently reported. Thrombocytopenia was the most frequently reported laboratory abnormality, use of heparin being associated with this in many cases. From these data, pefloxacin in routine clinical use appears to be well tolerated. For the agent to be used in children in the future, its safety in this population should first be carefully investigated. At present it is contraindicated in children under 15 years of age.
Insights
Pefloxacin is generally well-tolerated in routine clinical use, with skin, musculoskeletal, and CNS issues most frequently reported. Further safety studies are needed before pediatric use, as it is currently contraindicated in children under 15.
Area of Science:
- Pharmacology
- Clinical Pharmacy
- Drug Safety
Background:
- Pefloxacin has been available in France since 1985.
- Physician reporting of adverse events varies with event frequency and clinical significance.
Purpose of the Study:
- To analyze spontaneous adverse event reports for pefloxacin in clinical use.
- To assess the overall safety profile of pefloxacin based on reported data.
Main Methods:
- Review of 213 spontaneous adverse event reports submitted to Rhone-Poulenc Drug Safety Department.
- Analysis of 316 reported adverse events associated with pefloxacin use.
Main Results:
- The most frequent adverse events involved skin, musculoskeletal, and central nervous system (CNS) issues.
- Thrombocytopenia was the most common laboratory abnormality, often linked to concurrent heparin use.
- Overall, pefloxacin demonstrated good tolerability in routine clinical practice.
Conclusions:
- Pefloxacin appears well-tolerated in adult patients based on spontaneous reporting.
- Pefloxacin is contraindicated in children under 15 years of age.
- Future pediatric use requires thorough safety investigations in this population.