RESUMO
INTRODUCTION: Hearing loss can have a negative impact on communication, with significant vocational, educational, and social consequences. Drugs are one of the causes of hearing loss in children. OBJECTIVES: The objective of our study was to describe drug-induced hearing loss in the pediatric population. METHODS: Reports of hearing loss from 1985 to December 2019 in the pediatric population (< 18 years) were extracted from the French PharmacoVigilance Database (FPVD). We performed a retrospective and descriptive analysis of adverse drug reaction (ADR) reports. RESULTS: A total of 70 ADR reports were identified among the 51,216 reports registered in the FPVD, 37 involving adolescents (12-17 years, 52.9%), 28 children (2-11 years, 40.0%), and 5 infants (28 days-23 months, 7.1%). Overall, 40 reports (57.1%) involved girls. A total of 56 reports (80.0%) were "serious." The most frequent hearing disorders were deafness (n = 31, 44.3%) and hypoacusis (n = 22, 31.4%). Suspected drugs (ATC 5th level) were amikacin (n = 11, 15.7%), cisplatin (n = 11, 15.7%), doxorubicin (n = 4, 5.7%), vincristine (n = 4, 5.7%), clarithromycin (n = 4, 5.7%), ceftriaxone (n = 3, 4.3%), isotretinoin (n = 3, 4.3%), and vancomycin (n = 3, 4.3%). CONCLUSIONS: This study shows that about three out of four cases of drug-induced hearing loss in the pediatric population were "serious". It also underlines the under-reporting of these ADRs and the importance of strengthening hearing monitoring in children during and long after drug exposure.
