ArticleOphthalmic plastic and reconstructive surgery
Teprotumumab-Related Hearing Loss: A Large-Scale Analysis and Review of Voluntarily Reported Patient Complaints to the Food and Drug Administration (FDA).
Article in Ophthalmic plastic and reconstructive surgery. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
4 citing papers in PubMed.
- Audiologic Assessment and Management of Teprotumumab-Associated Ototoxicity: An Updated Narrative Review.Audiology research · 2026Review
- Review
- Teprotumumab and sensorineural hearing loss: a propensity score-matched retrospective cohort study.Endocrine connections · 2025Article
- Teprotumumab for the Treatment of Thyroid Eye Disease: Why Should We Keep Our Eyes "Wide Open"?-A Clinical and Pharmacovigilance Point of View.Journal of personalized medicine · 2024Article
Corrections and comments
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Authors and funding
3 authors.
Funding
Abstract
purposeAccumulating case reports and series have suggested that teprotumumab may significantly increase the risk of hearing impairment that, in some cases, does not resolve. This study investigates the association between hearing impairment and teprotumumab use.
methodsA disproportionality analysis was conducted using the United States Food and Drug Administration Adverse Event Reporting System, a publicly accessible database used for postmarketing surveillance and research. All adverse event reports containing the terms "teprotumumab" or "Tepezza" and a similar comparison group from all patients with the same indications for teprotumumab use (e.g., autoimmune thyroiditis, endocrine ophthalmopathy, and hyperthyroidism) but who had not received the drug were selected. Hearing impairment events were identified using the hearing impairment Standardized MedDRA Query.
resultsA total of 940 teprotumumab-associated adverse events were identified, including 84 hearing-related adverse events, with the first reported to the Food and Drug Administration in April 2020. A comparison group of 32,794 nonteprotumumab adverse events was identified with 127 hearing-related adverse events reported. Use of teprotumumab in patients with thyroid conditions was associated with a nearly 24-fold (proportional reporting ratio [PRR] 23.6, 95% confidence interval [CI]: 18.1-30.8) increased likelihood of any hearing disorder ( p value <0.0001). The association was specifically elevated for a variety of deafness conditions (e.g., bilateral deafness [PRR: 41.9; 95% CI: 12.8-136.9]), Eustachian tube disorders (PRR: 34.9; 95% CI: 4.9-247.4), hypoacusis (PRR: 10.1; 95% CI: 7.6-13.3), and tinnitus (PRR: 8.7; 95% CI: 6.2-12.1).
conclusionsPatients treated with teprotumumab should receive warnings regarding the increased risk of hearing-related impairments and receive audiometry before, during, and after treatment.
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