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Adefurin, Abiodun; Sammons, Helen; Jacqz-Aigrain, Evelyne; Choonara, Imti (2011)
Publisher: BMJ
Journal: Archives of Disease in Childhood
Languages: English
Types: Article
Subjects: 1513, Drug Therapy, 1506
Objective: To determine the safety of ciprofloxacin in\ud paediatric patients in relation to arthropathy, any other\ud adverse events (AEs) and drug interactions.\ud Methods: A systematic search of MEDLINE, EMBASE,\ud CINAHL, CENTRAL and bibliographies of relevant articles\ud was carried out for all published articles, regardless\ud of design, that involved the use of ciprofloxacin in any\ud paediatric age group ≤17 years. Only articles that\ud reported on safety were included.\ud Results: 105 articles met the inclusion criteria and\ud involved 16 184 paediatric patients. There were 1065\ud reported AEs (risk 7%, 95% CI 3.2% to 14.0%). The\ud most frequent AEs were musculoskeletal AEs, abnormal\ud liver function tests, nausea, changes in white blood cell\ud counts and vomiting. There were six drug interactions\ud (with aminophylline (4) and methotrexate (2)). The\ud only drug related death occurred in a neonate who had\ud an anaphylactic reaction. 258 musculoskeletal events\ud occurred in 232 paediatric patients (risk 1.6%, 95% CI\ud 0.9% to 2.6%). Arthralgia accounted for 50% of these.\ud The age of occurrence of arthropathy ranged from\ud 7 months to 17 years (median 10 years). All cases of\ud arthropathy resolved or improved with management.\ud One prospective controlled study estimated the risk of\ud arthropathy as 9.3 (OR 95% CI 1.2 to 195). Pooled safety\ud data of controlled trials in this review estimated the risk\ud of arthropathy as 1.57 (OR 95% CI 1.26 to 1.97).\ud Conclusion: Musculoskeletal AEs occur due to\ud ciprofloxacin use. However, these musculoskeletal events\ud are reversible with management. It is recommended that\ud further prospective controlled studies should be carried\ud out to evaluate the safety of ciprofloxacin, with particular\ud focus on the risk of arthropathy.
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