A Biologic With Otologic Consequences: Analysis of Hearing Loss and Teprotumumab Using the FDA Adverse Event Reporting System

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OBJECTIVES: To evaluate otologic adverse reactions (OARs), including hearing loss (OARs-HL) among patients taking teprotumumab, a new biologic approved for the treatment of active thyroid eye disease, using publicly available pharmacovigilance reporting data. STUDY DESIGN: Retrospective database review. METHODS: The Food and Drug Administration Adverse Events Reporting System (FAERS) was queried for cases involving teprotumumab from 2020Q1 to 2023Q1. Patient demographics and adverse reactions (OAR and OAR-HL) were evaluated. Logistic regression was used to predict OAR and OAR-HL, and disproportionality analysis was performed using OpenVigil. RESULTS: A total of 2,109 teprotumumab-AR cases were reported, of which 296 (14.05%; mean age 55.46 yr) were OARs. Of these, 149 (7.06%) reported OAR-HL and 194 (9.20%) reported other OAR (e.g., tinnitus, ear discomfort, vertigo), with 47 (2.23%) reporting both. Disproportionality analysis showed a reported odds ratio (ROR) for OARs-HL of 44.33 (95% confidence interval [CI], 37.40-52.55; p < 0.001). Age was associated with RORs of 1.02 (95% CI, 1.01-1.04) and 1.04 (95% CI, 1.02-1.07) for developing OARs and specifically OARs-HL, respectively (p < 0.01). Age 50 and 65 years and older were associated with RORs of 2.54 (95% CI, 1.16-6.38) and 3.36 (95% CI, 1.75-6.53), respectively, for OARs-HL (p < 0.05). CONCLUSION: This study using FAERS data suggests an increased risk of OARs, specifically hearing loss, associated with teprotumumab. Increasing age was a significant predictor of OARs. Audiometric counseling and evaluation should be considered with teprotumumab therapy in Graves' orbitopathy patients, especially in older patients.

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