Adverse Events Associated with IV Sedative Use and Related Mortality in the United States over an Eight Year Period

Abstract

Introduction: Types of adverse events (AEs) and associated mortality remain unclear for currently marketed IV sedatives in the USA. Hypothesis: AE frequency, AE type(s) and associated mortality differ between the following IV sedatives: dexmedetomidine (DE), diazepam (DI), etomidate (E), lorazepam (L), midazolam (M) and propofol (P). æMethods: æAll AEs were categorized using MedDRA coding by system organ class (SOC), HLGT and LLGT, where appropriate. The RXFilter¬ platform from Adverse Events, Inc. was used to search all relevant case reports from the FDAÍs Adverse Event Reporting System (AERS) from 2004 to 2011 where IV DE, DI, E, L, M or P was the primary suspected drug, the pt was ? 18 yo, and was cared for in the U.S.A. Results: æFor each IV sedative over the 8 year period, the number of pts with an AERS report, the total AEs described in these reports, the average AEs/report and the AERS reports where death was reported (%), were: æDE (141 pts, 261 AEs, 1.9, 8.5%); DI (113 pts, 208 AEs, 1.6, 11.7%); E (109 pts, 169 AEs, 1.6, 7.3%); L (150 pts, 380 AEs, 2.5, 14%); M (574 pts, 954 AEs, 1.6, 10.4%) and P (1,770 pts, 3,582 AEs, 2.0, 12.8%). æConclusions: æThe number of AERS reports attributable to the administration of IV sedatives over the past 8 years among American adults, the number and types of AEs contained in each report and the proportion of patients in these reports who died, vary substantially between currently marketed IV sedatives.