Impacto de la pandemia COVID-19 en los trastornos del oído y el laberinto: Análisis de la Ototoxicidad tras fármacos y vacunas en EudraVigilance

Analysis of Ototoxicity after Drugs and Vaccines in the European Pharmacovigilance Database EudraVigilance

Abstract

Introduction and objective: In recent years, an increase in the incidence of ototoxic adverse effects on the inner ear due to medications and/or vaccines has been detected, which seem to have increased exponentially during the COVID-19 pandemic. The analysis of notifications of adverse effects in health databases such as Fedra (Spain) or EudraVigilance (Europe) can allow us to deepen our knowledge of new drugs that cause ototoxic ADRs, epidemiological variables and prognostic factors. The objective of this work is to investigate the impact of the COVID-19 pandemic on Ototoxicity with symptoms of hearing loss, tinnitus and vertigo.Method: We have carried out an observational, descriptive and retrospective study of the spontaneous reports of adverse drug reactions (ADRs) that generated some symptom of ototoxicity, encompassing hearing loss (hypoacusis), vertigo (vertigo) and tinnitus (tinnitus) recorded in the European database EudraVigilance between 2010 and 2022.Results: The highest number of ototoxic ADR notifications occurred in 2021 with 10,548 cases of vertigo, 8,812 of tinnitus, and 1,697 of hearing loss. In previous years (2010-2020), the annual ranges of ADR cases of ototoxicity due to drugs and vaccines ranged from 311-2,255 for vertigo, 150-1,000 for tinnitus, and 129-548 for hearing loss.Discussion and Conclusions: The COVID-19 pandemic has triggered the notification of ototoxic ADRs since 2021. In view of the frequency, severity and persistent disability or sequelae that generates ototoxicity as ADR, monitoring programs should be implemented cochlear and vestibular function, to detect early the appearance of ototoxicity, identifying the most susceptible patients based on their pathology, necessary treatment, comorbidities and other associated factors. Pharmacovigilance systems perform a very important task, providing a valuable database from which otorhinolaryngologists can extract a large amount of useful knowledge for our patients.