Safety of inhaled (Tobi®) and intravenous tobramycin in young children with cystic fibrosis

Abstract

BackgroundUse of inhaled tobramycin therapy for treatment of Pseudomonas aeruginosa infections in young children with cystic fibrosis (CF) is increasing. Safety data for pre-school children are sparse. MethodsThe aim of this study was to assess the safety of tobramycin solution for inhalation (TOBI®-TSI) administered twice daily for 2months/course concurrently to intravenous (IV) tobramycin during P. aeruginosa eradication therapy in children (0–5years). Audiological assessment and estimation of glomerular filtration rate (GFR) was measured prior to any exposure and end of the study. ResultsData were available from 142 patients who were either never exposed to aminoglycosides (n=39), exposed to IV aminoglycosides only (n=36) or exposed to IV+TSI (n=67). Median exposure to TSI was 113days [59, 119]. Comparison of effects on audiometry results and GFR, showed no detectable difference between the groups. ConclusionsUse of TSI and IV tobramycin in pre-school children with CF was not associated with detectable renal toxicity or ototoxicity.