ArticleEcho research and practice2026
Reported safety events from ultrasound enhancing agents: a critical reappraisal.
Article in Echo research and practice, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Authors and funding
11 authors.
Funding
Abstract
backgroundReported adverse events (AEs) to the Food and Drug Administration Adverse Event Reporting System (FAERS) have suggested an increased rate of serious AEs (SAEs) during the COVID-19 pandemic, but the extent to which this may be related to overall changes in reporting during this time period is uncertain. Accordingly, we aimed to evaluate trends in SAE reporting across commercially available ultrasound enhancing agent (UEA) brands as a function of overall trends in AE reporting.
methodsWe retrospectively analyzed the FAERS public database, 2014-2024, to evaluate risks of UEAs overall and by brand, compared to similar contrast media.
resultsBetween 2014 and 2024, 21,960,760 AEs were reported to FAERS, of which 11,450,891 (52.1%) were categorized as SAEs. Overall SAE reports to FAERS increased from 678,953 in 2014 to 1,368,393 in 2021 before subsequently declining to 1,065,845 in 2024 (-7.9% change from 2021 to 2024). During the same period, overall death reports to FAERS increased from 124,055 in 2014 to 195,207 in 2018 before declining to 147,046 in 2024. During this period of decline, there was a 23.9% relative increase in SAEs to UEAs which peaked in 2023 at 350 before declining to 326 in 2024. Deaths attributed to SAEs increased from 1 in 2014 to 19 in 2023 before declining to 9 in 2024. Overall, these data suggest that 11.2% of the observed increase in SAEs to UEAs can be attributed to reporting changes. Despite changes in relative risks for SAEs, absolute SAE rates remained small and lower than other types of contrast media.
conclusionsIn this analysis of the FAERS dataset, 2014-2024, 11.2% of SAEs to UEAs were attributable to temporal changes in AE reporting. Absolute risks are small and declining, suggesting broad safety of UEAs as a class. Collectively, these results support continued use of UEAs, but motivate improved safety screening and preparedness to mitigate small but existing risks.
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