1130: ADVERSE EVENTS ASSOCIATED WITH IV SEDATIVE USE AND RELATED MORTALITY IN THE UNITED STATES OVER AN EIGHT YEAR PERIOD

Abstract

To maintain patient comfort, intravenous (IV) sedatives are frequently administered in both hospital and ambulatory settings. However, both the types of adverse events (AEs) and associated mortality remain unclear for currently marketed IV sedatives.

In American adults, 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).

All AEs reported in the package inserts for DE, DI, E, L, M and P were categorized using MedDRA coding by system organ class (SOC), high level group term (HLGT) and low level group terms (LLGT), where appropriate. The RXFilter® platform from Adverse Events, Inc. was used to search all relevant case reports from the FDA’s 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.

For 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: DE (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%). The 3 most frequent SOC’s (as a % of the total AEs identified for each IV sedative) were: DE [Cardiac(C)=43%, Neurologic(N)=20%, Respiratory(R)=18%]; DI [R=27%, N=26%, Injection Site(IS)=20%]; E (C=38%, N=33%, R=11%); L (N=38%, R=21%, C=17%); M (N=34%, C=27%, R=18%); and P (C=29%, N=14%, IS=13%).

The 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. The prevalence of AE combinations (including syndromes), the presence of other deleterious outcomes related to these AERS reports and AERS report incidence relative to actual IV sedative exposure requires further investigation.