Fall Reporting with GLP-1 Receptor Agonists in Older Adults: A FDA Adverse Event Reporting System (FAERS) Disproportionality Analysis
Falls are reported significantly more often in older adults using GLP-1 receptor agonists, with a reporting odds ratio of 2.75. This finding highlights the need for careful monitoring in this population.
Where it sits
this study against the rest of the liraglutide corpusSummary and findings
This study analyzed adverse event reports related to falls in older adults using GLP-1 receptor agonists, specifically comparing those aged 65–84 years to those younger than 65 years. The analysis included 186,942 eligible reports and found that falls were significantly overrepresented in older patients. The reporting odds ratio for falls was 2.75 (95% CI 2.47–3.06).
Abstract
Abstract Purpose This study characterize age-related differences in falls, syncope, and orthostatic hypotension reporting among users of GLP-1 receptor agonists (GLP-1 RAs), and to test whether falls are disproportionately reported in older adults independent of hemodynamic mechanisms. Methods We performed a disproportionality analysis of FAERS individual case safety reports for semaglutide, tirzepatide, liraglutide, and dulaglutide. Reporting odds ratios (RORs) compared patients aged 65–84 years with patients aged < 65 years for Fall and a secondary hemodynamic cluster (Syncope, Presyncope, Orthostatic Hypotension, Dizziness, Postural Hypotension). Multivariable adjustment, Fisher's exact/Bonferroni correction, Bayesian credibility intervals, and a supplementary ≥ 85-year analysis were performed. Results Among 186,942 eligible reports, Fall was strongly overrepresented in older patients (ROR 2.75, 95% CI 2.47–3.06), unlike Syncope (ROR 0.96, 95% CI 0.83–1.12) or Orthostatic Hypotension (ROR 1.36, non-significant). This pattern was persisted after multivariable adjustment (adjusted OR 2.34, 95% CI 2.09–2.61). Fall ROR increased with age: 2.30 (65–74y), 3.91 (75–84y), 7.13 (≥ 85y). Conclusion Falls, but not syncope or orthostatic hypotension, show a strong, age-related reporting signal in GLP-1 RA users. These hypothesis-generating findings warrant confirmation with patient studies incorporating frailty and polypharmacy adjustment.