Postmarketing Safety Concerns of Teprotumumab: A Real-World Pharmacovigilance Assessment
Authors' conclusion
This 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.
Study context
- Population
- Postmarketing AE reports of teprotumumab, Food and Drug Administration (FDA) Adverse Event Reporting System (FDA Adverse Event Reporting System (FAERS)), 2023
- Participants
- 2,158 cases
- Outcome
- Safety signals: Reporting odds ratio (ROR) and information component (IC) with 95% CI for adverse events (AEs) numbering 3 or more
Methodological detailsdisproportionality analysis of the FAERS database, case/noncase approach, postmarketing
- Disproportionality analysis of the FAERS database
- Case/noncase approach
- Postmarketing
Main finding
As reported in the abstract
Safety signals of teprotumumab
TeprotumumabROR (95% CI)
Autophony
4188.34(1403.29–12500.8)
Eyelid retraction
2094.17(850.69–5155.29)
Permanent deafness
1552.35(789.07–3053.98)
Bilateral deafness
73.12(41.14–129.97)
Inflammatory bowel disease
23.26(13.46–40.19)
Hyperglycemic hyperosmolar nonketotic syndrome
17.75(5.70–55.28)
Amenorrhea
47.98(36.22–63.54)
Observational data: associations, not effects.
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Postmarketing Safety Concerns of Teprotumumab: A Real-World Pharmacovigilance Assessment. J Clin Endocrinol Metab. Published 15 June 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →