Anticancer drug-induced life-threatening ventricular arrhythmias: a World Health Organization pharmacovigilance study
Study context
- Population
- Reports of drug-induced long QT and ventricular arrhythmias (VA), incl. Torsade de pointes (TdP), in VigiBase until 01/01/2019VigiBase reports
- Participants
- 18,441,659 reports
- Exposure
- Anticancer drugs vs all other drugs
- Outcome
- Disproportionate reporting of diLQT and VA, incl. TdP (IC025 >0 significant)
Methodological detailsdisproportionality analysis, international pharmacovigilance database (VigiBase), Bayesian disproportionality analysis (information component (IC025)), Proposed 3-level SD risk stratification: isolated long QT (low), VA without SD (moderate), VA with SD (high)
- Disproportionality analysis
- International pharmacovigilance database (VigiBase)
- Bayesian disproportionality analysis (IC025)
- Proposed 3-level SD risk stratification: isolated long QT (low), VA without SD (moderate), VA with SD (high)
Main finding
As reported in the abstract
Anticancer drugs with a significant signal
- Anticancer drugs significantly associated with drug-induced long QT (diLQT) (27 also associated with VA or SD)
- 40
- Reports for these drugs (13.8% fatal)
- 2301
- Drugs associated with VA without diLQT
- 9
- Drugs associated with SD
- 46.9%, 23/49
- Kinase inhibitors
- 41%, 20/49
- Hormonal therapies
- 8% (4/49)
- Immunotherapies
- 6% (3/49)
- Cytotoxics
- 24% (12/49)
- Miscellaneous
- 20% (10/49)
Observational data: associations, not effects.
Further findings
Proportion of diLQT, TdP or VA reports related to anticancer drugs over time · 1967-83 to 2014-18
- Reports of diLQT, TdP or VA, 1967-83 to 2014-18
- 580 to 15 070
- Proportion related to anticancer drugs
- 0.9% (5/580) to 14.0% (2115/15 070)
- P < 0.0001
Concordance of VigiBase signals with CredibleMeds or Food and Drug Administration (FDA) labels
- Moderate concordance (κ)
- 0.47 and 0.40
- New signals
- 23
- Flagged by CredibleMeds or FDA without VigiBase signal
- 24
- P < 0.0001
Original publication
Anticancer drug-induced life-threatening ventricular arrhythmias: a World Health Organization pharmacovigilance study. Eur Heart J. Published 9 August 2021. doi:10.
Summarised from the published abstract; every number is checked against it