Cardiovascular Safety Signals of Osteoporosis Therapies: A FAERS Pharmacovigilance Study.
Denosumab and abaloparatide showed lower cardiovascular risk signals compared to other osteoporosis medications, but further evaluation is needed to confirm these findings.
Where it sits
this study against the rest of the abaloparatide (tymlos) corpusSummary and findings
This study evaluated associations between osteoporosis medications and major adverse cardiovascular events (MACE) using FDA Adverse Event Reporting System data. The analysis included medications such as abaloparatide and assessed outcomes like myocardial infarction and stroke. Findings indicated that denosumab and abaloparatide had the lowest reporting odds ratios for cardiovascular outcomes.
Abstract
Objective To evaluate the associations between commonly used osteoporosis medications and major adverse cardiovascular events (MACE) using data from the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). Methods We conducted a retrospective pharmacovigilance analysis of FAERS reports between January 2019 and December 2024, identifying all reports involving alendronate, risedronate, zoledronic acid, denosumab, teriparatide, abaloparatide, or romosozumab. MACE outcomes included myocardial infarction (MI), stroke, atrial fibrillation (A-fib), and cardiac failure (CF), defined using Medical Dictionary for Regulatory Activities Preferred Terms. Disproportionality was assessed using reporting odds ratios (RORs), with signals defined by a lower 95% confidence interval >1. All analyses were descriptive and hypothesis-generating. Results FAERS contained more than 30 million adverse event reports during the study period. Romosozumab demonstrated the highest ROR for MI (2.38) and stroke (3.72), and also showed elevated signals for A-fib and CF (ROR 3.76). Zoledronic acid showed notable associations with stroke (ROR 2.42) and A-fib (ROR 3.22). Denosumab and abaloparatide were associated with the lowest RORs across all cardiovascular outcomes. Alendronate and risedronate demonstrated intermediate disproportionality signals, particularly for A-fib and CF. Conclusion Romosozumab and zoledronic acid demonstrated prominent cardiovascular disproportionality signals in FAERS, whereas denosumab, abaloparatide, and teriparatide showed more favorable reporting profiles. These findings should not discourage osteoporosis treatment but underscore the importance of individualised cardiovascular risk assessment and the need for further prospective evaluation to inform safe therapy selection.