Key result
COVID-19 vaccine reporting surge masks antineoplastic-associated cardiovascular safety signals in pharmacovigilance data.
Why the study?
Increased reports of COVID-19 vaccine-related adverse cardiovascular events in the pharmacovigilance database have affected disproportionality analysis results for antineoplastic drug-associated adverse cardiovascular events.
Does the inclusion of COVID-19 vaccine reports in pharmacovigilance databases mask safety signals for antineoplastic drug-associated adverse cardiovascular events?
Observational
Does the inclusion of COVID-19 vaccine reports in pharmacovigilance databases mask safety signals for antineoplastic drug-associated adverse cardiovascular events?
The rapid increase in COVID-19 vaccine-related adverse event reports in pharmacovigilance databases can mask safety signals for antineoplastic drug-associated cardiovascular events.
Vaccine reporting surges may obscure antineoplastic cardiovascular signals in pharmacovigilance databases; leaves open true risk estimates and requires adjusted signal-detection methods.
BACKGROUND: Antineoplastic drug-associated adverse cardiovascular events (ACEs) are a concern; however, information on new antineoplastic drugs is limited. In this situation, signal detection and hypothesis building by analyzing the pharmacovigilance database are useful. However, increased numbers of reports on COVID-19 vaccine-related ACEs in the pharmacovigilance database have affected the results of the disproportionality analysis. Therefore, examining the effect of increased reports on COVID-19 vaccine-related ACEs on detecting anticancer drug-related ACEs is critical. RESEARCH DESIGN AND METHODS: Disproportionality analysis was performed using the Japanese Adverse Drug Event Report (JADER) database. Reporting odds ratio and information components were used as indicators to detect potential associations between drugs and adverse events. The analysis was performed in two situations: using all data in the JADER database and excluding cases with the COVID-19 vaccine. RESULTS: Various antineoplastic drugs were associated with diverse ACEs. Additionally, safety signals for ACEs of some antineoplastic drugs were masked by reports on COVID-19 vaccine-related ACEs. CONCLUSIONS: The rapid increased reports on COVID-19 vaccine-related ACEs in the JADER database had an impact on signal detection activities for antineoplastic drug-associated ACEs. Therefore, the impact of reporting COVID-19 vaccine-related ACEs on current signal detection activities should be evaluated over time.
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Matsuo et al. (2024) conducted an observational in Antineoplastic drug-associated adverse cardiovascular events. Inclusion of COVID-19 vaccine reports vs. Exclusion of COVID-19 vaccine reports was evaluated on Detection of potential associations between antineoplastic drugs and adverse cardiovascular events. The rapid increase in COVID-19 vaccine-related reports in the JADER database masked safety signals for adverse cardiovascular events associated with some antineoplastic drugs.
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