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Safety of ciprofloxacin in children: Worldwide clinical experience based on compassionate use. Emphasis on joint evaluation

Verträglichkeit von Ciprofloxacin bei Kindern unter besonderer Beachtung der Gelenke. Auswertung weltweit dokumentierter Problemfälle

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  • Quinolones In Clinical Use
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Summary

Six hundred and thirty four adolescents and children aged three days to 17 years treated with ciprofloxacin on a compassionate basis were analysed for drug safety. 62% of the ciprofloxacin courses were given to patients with respiratory tract infection, primarily those with acute pulmonary exacerbation of cystic fibrosis. The mean daily oral dose was 25.2 mg/kg body weight. The duration of treatment ranged from one to 880 days (mean 22.8 days). Because of the arthropathogenic potential of quinolones in juvenile animals special emphasis was placed on the evaluation of musculoskeletal adverse events. Arthralgia considered by the treating physicians to be related to ciprofloxacin was reported in eight children, all of whom were females. Arthralgia resolved in all children. Some of these children were given subsequent courses of ciprofloxacin with no complaints of arthralgia. Overall, the safety profile of ciprofloxacin in children is not substantially different from that of adults.

Zusammenfassung

Die Verträglichkeit des Ciprofloxacin nach Anwendung bei 634 Jugendlichen und Kindern im Alter von drei Tagen bis 17 Jahren wurde analysiert. 62% der Behandlungen mit Ciprofloxacin erhielten Patienten mit Atemwegsinfektionen, insbesondere mit akuter pulmonaler Exazerbation der Mukoviszidose. Der Mittelwert der oralen Tagesdosis war 25,2 mg/kg Körpergewicht. Die Therapiedauer variierte zwischen 1 und 880 Tagen (Mittelwert 22,8 Tage). Wegen der gelenkknorpelschädigenden Wirkung der Chinolone bei juvenilen Versuchstieren wurde besondere Aufmerksamkeit der Beurteilung der mit Gelenken verbundenen Nebenerscheinungen gewidmet. Arthralgie, die von den behandelnden Ärzten als Folge der Ciprofloxacin-Behandlung beurteilt wurde, ist bei acht Kindern berichtet worden. Alle waren weiblich. Die Arthralgie verschwand bei allen Kindern. Einige dieser Kinder erhielten nachträgliche Behandlungen mit Ciprofloxacin ohne Auftreten arthralgischer Beschwerden. Generell unterschied sich das Verträglichkeitsprofil bei Kindern nicht wesentlich von dem der Erwachsenen.

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Authors and Affiliations

  1. Bayer AG, Pharma Forschungszentrum, Klinische Forschung Deutschland, Postfach 10 17 09, W-5600, Wuppertal 1, Germany

    V. Chyský,  R. Hullmann &  P. Schacht

  2. Miles Inc., Pharmaceutical Div., 400 Morgan Lane, 06516, West Haven, CT, USA

    K. Kapila M.D. & R. Echols M.D.

  3. Miles Inc., 400 Rella Blvd., Suite 170, 10901, Suffern, NY, USA

    G. Arcieri M.D.

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  1. V. Chyský
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  4. K. Kapila M.D.
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  5. R. Echols M.D.
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  6. G. Arcieri M.D.
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Chyský, V., Hullmann, R., Schacht, P. et al. Safety of ciprofloxacin in children: Worldwide clinical experience based on compassionate use. Emphasis on joint evaluation. Infection 19, 289–296 (1991). https://doi.org/10.1007/BF01644970

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