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Related Experiment Videos

Pefloxacin: safety in man.

J Simon1, A Guyot

  • 1Rhone-Poulenc Santé, Antony, France.

The Journal of Antimicrobial Chemotherapy
|October 1, 1990
PubMed
Summary

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.

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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.

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