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Friday 26 October 1990

Pefloxacin: safety in man.

By: Simon J, Guyot A

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.

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