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Drug-Induced Hearing Loss in Children: An Analysis of Spontaneous Reports in the French PharmacoVigilance Database

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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.

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Authors and Affiliations

  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

    Adrien Gainville, Vanessa Rousseau, Leila Chebane, Jean-Louis Montastruc & Geneviève Durrieu

  2. Centre d’Investigation Clinique, INSERM CIC1426, Hôpital Robert Debré, 48, boulevard Sérurier, 75019, Paris, France

    Florentia Kaguelidou

  3. Service de pharmacologie clinique et pharmacovigilance, centre régional de pharmacovigilance Marseille Provence Corse, hôpital Sainte-Marguerite, Hôpitaux de Marseille, 13009, Marseille, France

    Marie Boyer Gervoise

  4. Centre Régional de Pharmacovigilance, Saint Antoine Hôpital (APHP), Paris, France

    Joëlle Michot

  5. Service Hospitalo-Universitaire de Pharmacotoxicologie, Centre de Pharmacovigilance, Hospices Civils de Lyon, CHU-Lyon, Lyon, France

    Véronique Pizzoglio-Bellaudaz

  6. Service d’ORL pédiatrique, Centre Hospitalier Universitaire de Toulouse, Toulouse, France

    Alexandra Weckel

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  1. Adrien Gainville
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  9. Jean-Louis Montastruc
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  10. Geneviève Durrieu
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Corresponding author

Correspondence to Geneviève Durrieu.

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Funding

No funding was received for this study.

Conflict of interest

The authors, AG, VR, FK, MBG, JM, VPB, LC, AW, JLM, and GD, declare that they have no conflicts of interest relevant to the contents of this article.

Ethics approval

This study was conducted in accordance with international ethical guidelines. Ethics approval was not required for this study.

Author contributions

AG, VR, FK, LC, JLM, and GD all made substantial contributions to the concept and design, or analysis and interpretation of data, and to the drafting of the manuscript. All authors reviewed, contributed to revisions and approved the manuscript and accept full responsibility for its overall content.

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Gainville, A., Rousseau, V., Kaguelidou, F. et al. Drug-Induced Hearing Loss in Children: An Analysis of Spontaneous Reports in the French PharmacoVigilance Database. Pediatr Drugs 23, 87–93 (2021). https://doi.org/10.1007/s40272-020-00425-z

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