A real‑world pharmacovigilance study of FDA adverse event reporting system events for daratumumab

Yun, Xiaolin; Zhou, Yingying; Wu, Danna; Liu, Yuanbo; Wu, Qiongshi

doi:10.1080/14740338.2024.2328321

Expert Opinion on Drug Safety

2024

DOI: 10.1080/14740338.2024.2328321

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A real‑world pharmacovigilance study of FDA adverse event reporting system events for daratumumab

Xiaolin Yun,

Yingying Zhou,

Danna Wu

et al.

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2024

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The Impact of Monoclonal Antibody Usage on Hearing Outcomes: A Systematic Review

Arya,

Salmerón,

Quimby

et al. 2024

The Laryngoscope

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ObjectiveTo ascertain trends in ototoxicity observed with monoclonal antibodies (mABs) and understand the impact they may have on hearing function.Data SourcesPubMed, Embase, Scopus.Review MethodsA systematic review was performed following PRISMA guidelines. Data were reviewed for demographics, utilized mABs with respective indication and dosing, audiometric outcomes, and treatment for otologic effects.ResultsOf 757 studies reviewed, a total of 44 were included, encompassing 18,046 patients treated with mABs. Mean age of the sample was 57.8 years old. The search yielded 18 agents of ototoxicity, with reported symptoms of ototoxicity such as hearing loss, tinnitus, and/or aural fullness occurring in 1079 of total patients. Main agents causing ototoxicity were teprotumumab (n = 17/44 studies), nivolumab (n = 10/44), ipilimumab (n = 9/44), pembrolizumab (n = 5/44), and rituximab (n = 4/44). Thirty‐one of 44 studies encompassing eight agents reported audiometric data for ototoxic agents, showing sensorineural hearing loss primarily in the high‐frequency range. Only two articles performed ultrahigh‐frequency audiograms.ConclusionMonoclonal antibody usage is expanding, but the vast majority of studies lack substantial audiometric data. Where reported, study design and inclusion criteria vary greatly. Future studies would benefit from rigid inclusion of audiometric data, prospective study design, and consideration of formal ototoxicity screening. Otolaryngologists should be aware of the cochlear immune response and potential impact of this expanding medication class on hearing function. Laryngoscope, 2024

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The Impact of Monoclonal Antibody Usage on Hearing Outcomes: A Systematic Review

Arya,

Salmerón,

Quimby

et al. 2024

The Laryngoscope

View full text Add to dashboard Cite

show abstract

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A real‑world pharmacovigilance study of FDA adverse event reporting system events for daratumumab

Cited by 1 publication

References 34 publications

The Impact of Monoclonal Antibody Usage on Hearing Outcomes: A Systematic Review

The Impact of Monoclonal Antibody Usage on Hearing Outcomes: A Systematic Review

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