A real-world pharmacovigilance study of abaloparatide based on the FDA Adverse Event Reporting System (FAERS)
Authors' conclusion
Our study provided a deeper and broader understanding of abaloparatide's safety profiles, which would help healthcare professionals to mitigate the risk of AEs in clinical practice, a low number of unexpected AEs supporting ongoing additional pharmacovigilance.
Study context
- Population
- FAERS reports with abaloparatide as the primary suspected drug, 2017 Quarter 2 to 2022reports
- Participants
- 11,487 reports
- Outcome
- Signals of abaloparatide-related adverse events (AEs)
Methodological detailsdisproportionality analysis of the FAERS database, retrospective, data mining, reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN) and MGPS signal detection, serious vs non-serious cases compared by Mann-Whitney U or χ2 test
- Disproportionality analysis of the FAERS database
- Retrospective
- Data mining
- ROR, PRR, BCPNN and MGPS signal detection
- Serious vs non-serious cases compared by Mann-Whitney U or χ2 test
Main finding
As reported in the abstract
Abaloparatide-related AE signals
- Signals conforming to all four algorithms
- 99
- Unexpected signals
- 35
- Growing pains (unexpected signal), reports
- 13
- Waist circumference increased (unexpected signal), reports
- 21
- Sensory disturbance (unexpected signal), reports
- 103
- Tinnitus (unexpected signal), reports
- 65
- Visual acuity reduced (unexpected signal), reports
- 54
- Blood alkaline phosphatase increased (unexpected signal), reports
- 61
- Hair growth abnormal (unexpected signal), reports
- 13
Observational data: associations, not effects.
Further findings
Reporter type
- Reports by healthcare professionals (n=4154)
- 36.16%
- Reports by consumers (n=7140)
- 62.26%
Association of patient age with AE severity
- Patient age might be associated with increased risk of AE severity
- P < 0.001
Time to AE onset
- Most common timeframe for AE occurrence
- 0-7 days
Original publication
A real-world pharmacovigilance study of abaloparatide based on the FDA Adverse Event Reporting System (FAERS). Osteoporos Int. Published 18 August 2023. doi:10.
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