ArticleThe Journal of clinical endocrinology and metabolism2024
Postmarketing Safety Concerns of Teprotumumab: A Real-World Pharmacovigilance Assessment.
Article in The Journal of clinical endocrinology and metabolism, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
8 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Comparative efficacy and safety of rituximab, tocilizumab, and teprotumumab in Graves' orbitopathy: a systematic review and meta-analysis.Eye (London, England) · 2025Pooled it
- Comparison of the 2021 EUGOGO guidelines and the 2022 ATA/ETA consensus statement for the management of Graves' orbitopathy.European thyroid journal · 2025Review
- Targeting IL-6 Receptor Signaling with Satralizumab in Thyroid Eye Disease: Design of the Phase 3 SatraGO-1 and SatraGO-2 Trials.Ophthalmology and therapy · 2025Article
- Redefining Treatment Paradigms in Thyroid Eye Disease: Current and Future Therapeutic Strategies.Journal of clinical medicine · 2025Review
- Real world pharmacovigilance study of antineoplastic drug related vitiligo risks.Scientific reports · 2025Article
- Assessment of Hearing Dysfunction in Patients With Graves' Disease and Thyroid Eye Disease Without or With Teprotumumab.The Journal of clinical endocrinology and metabolism · 2025Article
- Emerging therapeutic approaches in graves' ophthalmopathy: an update on pharmacological interventions.Frontiers in immunology · 2025Review
- Linear IgA bullous dermatosis secondary to drugs: a real-world pharmacovigilance study of the FDA adverse event reporting system.Frontiers in medicine · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
Abstract
contextTeprotumumab, which targets the insulin-like growth factor-1 receptor, is the only drug approved by the US Food and Drug Administration (FDA) for the treatment of thyroid eye disease (TED).
objectiveThis study aimed to identify potential safety signals of teprotumumab by analyzing postmarketing safety data from the FDA Adverse Event Reporting System (FAERS) database in 2023.
methodsThe case/noncase approach was used to estimate the reporting odds ratio (ROR) and information component (IC) with relevant 95% CI for adverse events (AEs) that numbered 3 or more.
resultsA total of 2158 cases were included in the analysis. Main safety signals identified were ear and labyrinth disorders, reproductive system and breast disorders, metabolism and nutrition disorders, and gastrointestinal disorders. Specifically, autophony (ROR [95% CI] = 4188.34 [1403.29-12500.8]), eyelid retraction (ROR [95% CI] = 2094.17 [850.69-5155.29]), permanent deafness (ROR [95% CI] = 1552.35 [789.07-3053.98]), bilateral deafness (ROR [95% CI] = 73.12 [41.14-129.97]), inflammatory bowel disease (ROR [95% CI] = 23.26 [13.46-40.19]), hyperglycemic hyperosmolar nonketotic syndrome (ROR [95% CI] = 17.75 [5.70-55.28]), and amenorrhea (ROR [95% CI] = 47.98 [36.22-63.54]) showed significant safety signals with teprotumumab.
conclusionThis study identified ear and labyrinth disorders, and reproductive system and breast disorders, as specific safety signals of teprotumumab. Clinicians and pharmacists should be vigilant regarding these AEs. However, available data are currently insufficient, and further pharmacovigilance and surveillance are needed to fully understand this issue.
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Registered trials
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