Reports of drug-induced hearing loss in paediatric patients
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Reports of drug-induced hearing loss in paediatric patients According to the results of a study investigating paediatric drug-induced hearing loss in the French Pharmacovigilance Database (FFVD), reported in Pediatric Drugs, 80% of cases were classified as serious. The study evaluated 51 216 adverse drug reaction (ADR) reports in 1985–2019 to identify 70 cases of hearing loss in paediatric patients, comprising infants (n=5), children (n=28) and adolescents (n=37); 57.1% of cases were girls. There were 56 serious cases (80%), including incapacities/disabilities (n=28), hospitalisations (n=12) and medically important reactions (n=16). The most frequently reported ADR was deafness (44.3%), followed by hypoacusis (31.4%), bilateral deafness (10.0%) and auditory disorders (5.7%). There were 13 patients (18.6%) with comorbidities potentially associated with hearing loss, including brain tumour, cranial trauma, HIV infection, Lobstein disease, meningitis, otitis and prematurity. The most commonly suspected drugs were amikacin or cisplatin (15.7% each), followed by clarithromycin, doxorubicin or vincristine (5.7% each) and ceftriaxone, MMR vaccine, isotretinoin or vancomycin (4.3% each). Ten patients were co-prescribed ototoxic drugs, mostly two antineoplastics or two antibacterials. Patients were treated for 1 day to 8 months, with hearing loss mostly detected a few days to several months after treatment initiation, although in four cases diagnosis occurred 2–9 years after drug withdrawal. "Hearing loss with doxorubicin or ceftriaxone is an unexpected ADR not described in the literature", note the authors; however, "our study did not allow us to draw a conclusion about these two drugs, because of their association with other ototoxic drugs or known hearing-loss risk factors". In addition, although "the low number of ADR reports registered in the FPVD suggests an important under-reporting of drug-induced hearing loss in the pediatric population, limiting the scope of our results", "these results underline the importance of strengthening hearing monitoring in children during and long after drug treatment". Gainville A, et al. Drug-Induced Hearing Loss in Children: An Analysis of Spontaneous Reports in the French PharmacoVigilance Database. Pediatric Drugs : 17 Nov 2020. 803519189 Available from: URL: http://doi.org/10.1007/s40272-020-00425-z
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Reactions 5 Dec 2020 No. 1833
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