Serious Cardiovascular Adverse Events Reported with Intravenous Sedatives: A Retrospective Analysis of the MedWatch Adverse Event Reporting System

Autor: Matthew S. Duprey, Nada S. Al-Qadheeb, Nick O’Donnell, Keith B. Hoffman, Jonathan Weinstock, Christopher Madias, Mo Dimbil, John W. Devlin
Jazyk: angličtina
Rok vydání: 2019
Předmět:
Zdroj: Drugs - Real World Outcomes, Vol 6, Iss 3, Pp 141-149 (2019)
Druh dokumentu: article
ISSN: 2199-1154
2198-9788
DOI: 10.1007/s40801-019-00161-y
Popis: Abstract Background Serious cardiovascular adverse events (SCAEs) associated with intravenous sedatives remain poorly characterized. Objective The objective of this study was to compare SCAE incidence, types, and mortality between intravenous benzodiazepines (i.e., diazepam, lorazepam, and midazolam), dexmedetomidine, and propofol in the USA over 8 years regardless of the clinical setting where it was administered. Methods The Food and Drug Administration’s MedWatch Adverse Event Reporting System was searched between 2004 and 2011 using the Evidex® platform from Advera Health Analytics, Inc. to identify all reports that included one or more of ten different SCAEs (package insert incidence ≥ 1%) and where an intravenous benzodiazepine, dexmedetomidine, or propofol was the primary suspected drug. Results Among the 2326 Food and Drug Administration’s MedWatch Adverse Event Reporting System cases reported, 394 (16.9%) were related to a SCAE. The presence of a SCAE (vs. a non-SCAE) is associated with higher mortality (34 vs. 8%, p
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