Drug-Induced Hearing Loss in Children: An Analysis of Spontaneous Reports in the French PharmacoVigilance Database
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ORIGINAL RESEARCH ARTICLE
Drug‑Induced Hearing Loss in Children: An Analysis of Spontaneous Reports in the French PharmacoVigilance Database Adrien Gainville1 · Vanessa Rousseau1 · Florentia Kaguelidou2 · Marie Boyer Gervoise3 · Joëlle Michot4 · Véronique Pizzoglio‑Bellaudaz5 · Leila Chebane1 · Alexandra Weckel6 · Jean‑Louis Montastruc1 · Geneviève Durrieu1 Accepted: 24 October 2020 © Springer Nature Switzerland AG 2020
Abstract 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. * Geneviève Durrieu genevieve.durrieu@univ‑tlse3.fr 1
Service de Pharmacologie Médicale et Clinique, Centre Régional de Pharmacovigilance, Pharmacoépidémiologie et Informations sur le Médicament, INSERM U 1027, CIC INSERM 1436, Centre Hospitalier Universitaire et Faculté de Médecine de Toulouse, France, 37 Allées Jules Guesde, 31000 Toulouse, France
2
Centre d’Investigation Clinique, INSERM CIC1426, Hôpital Robert Debré, 48, boulevard Sérurier, 75019 Paris, France
3
Service de pharmacologie clinique et pharmacovigilance, centre régional de pharmacovigilance Marseille Provence Corse, hôpital Sainte-Marguerite, Hôpitaux de Marseille, 13009 Marseille, France
4
Centre Régional de Pharmacovigilance, Saint Antoine Hôpital (APHP), Paris, France
5
Service Hospitalo‑Universitaire de Pharmacotoxicologie, Centre de Pharmacovigilance, Hospices Civils de Lyon, CHU-Lyon, Lyon, France
6
Service d’ORL pédiatrique, Centre Hospitalier Universitaire de Toulouse, Toulouse, France
1 Introduction Around 34 million children worldwide have disabling hearing loss [1]. Damage to the aud
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