Fluoroquinolones given to children result in higher rates of adverse events than other antibiotics

Since the American Academy of Pediatrics have recommended prescribing fluoroquinolones as a second-line antibiotic and restricting their use to a few specific situations, including Pseudomonas aeruginosa infections in patients with cystic fibrosis, prophylaxis and treatment of bacterial infections in immunocompromised patients, life-threatening multiresistant bacterial infections in newborns and infants, and Salmonella or Shigella gastrointestinal tract infections, French researchers evaluated the safety of fluoroquinolones in comparison with other antibiotics in pediatric patients via a multicenter, observational, comparative cohort study conducted between 1998 and 2000 in French pediatric departments. Patients were recruited from 73 centers: 276 patients were exposed to fluoroquinolones, and 249 composed the control group.

They found that among patients who were exposed to fluoroquinolones, 23% were younger than 2 years, 33% had cystic fibrosis, and potential adverse events occurred in 52 patients, leading to withdrawal for 11. The odds ratio for potential adverse events in the fluoroquinolones group was 3.7 and was not significantly modified after adjustment for potential confounders. Musculoskeletal potential adverse events also occurred more frequently in the fluoroquinolones group (3.8%) than in controls (0.4%); they were recorded in 10 patients who were receiving standard fluoroquinolones doses and were of moderate intensity and transient.

The researchers concluded: " The rates of potential adverse events and musculoskeletal potential adverse events were higher for the fluoroquinolones group than the control group. This observation supports the American Academy of Pediatrics statement restricting off-label fluoroquinolones use in pediatric patients to second-line treatment in a limited number of situations."

Pediatrics Vol. 111 No. 6 June 2003, pp. e714-e719 © 2003 American Academy of Pediatrics ICPC-2 A. General/Unspecified

Fluoroquinolone Safety in Pediatric Patients: A Prospective, Multicenter, Comparative Cohort Study in France, Martin Chalumeau, MD, Sylvie Tonnelier, PharmD, Philippe d'Athis, PhD, Jean-Marc Tréluyer, MD, PhD, Dominique Gendrel, MD, Gérard Bréart, MD and Gérard Pons, MD, PhD the Pediatric Fluoroquinolone Safety Study Investigators

Posted on Global Family Doctor 4 June 2003