Heart failure & cardiomyopathies
Drug-associated Takotsubo syndrome risk profiling: a global pharmacovigilance study
Authors' conclusion
In spontaneous pharmacovigilance reports, Takotsubo syndrome is disproportionately reported with multiple drug classes, most prominently catecholaminergic agents. Disproportionate reporting with ICIs was observed within an oncology population, although with a lower magnitude than carboplatin and paclitaxel. These findings support cautious clinical awareness while highlighting the need for confirmatory observational studies to clarify absolute risk and underlying mechanisms.
Study context
- Population
- Reports submitted to the Food and Drug Administration Adverse Event Reporting System between 2004 and the second quarter of 2025Takotsubo syndrome reports among >22 million adverse event reports
- Participants
- 5,213 participants
- Exposure
- Takotsubo syndrome reporting with each drug vs other drugs/reports
- Outcome
- Characteristics of Takotsubo syndrome reports
Methodological detailsdisproportionality methods, including reporting ORs and Bayesian information components, sensitivity analyses excluded catecholaminergic agents and selected concomitant therapies
- Disproportionality methods, including reporting ORs and Bayesian information components
- Sensitivity analyses excluded catecholaminergic agents and selected concomitant therapies
Main finding
As reported in the abstract
Women
74.8%
>60 years
44.4%
Hospitalisation
51.6%
Life-threatening outcomes
21.7%
Observational data: associations, not effects.
Further findings
Reporting disproportionality, catecholaminergic agents
| ROR (95% CI) | ||
|---|---|---|
| Dobutamine | 283.83 (226.55–355.60) | |
| Norepinephrine | 160.70 (126.42–204.28) | |
| 0.050.21520Reporting OR (log scale) |
- Catecholaminergic agents showed the highest reporting disproportionality
Disproportionality after exclusion of catecholaminergic agents (sensitivity analysis)
- Disproportionate reporting persisted across several non-catecholaminergic drug classes, including antineoplastic and central nervous system-active drugs
Immune checkpoint inhibitors (ICIs)
- ICI reports
- 219
- ICIs demonstrated disproportionate reporting
- Lower disproportionality for ICI-only reports than for carboplatin-only or paclitaxel-only reports (pairwise comparisons)
Original publication
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