Author:
Buchholz Udo,Richards Chesley,Murthy Rekha,Arduino Matthew,Pon Doreen,Schwartz Wayne,Fontanilla Elsie,Pegues Clare,Boghossian Noemy,Peterson Carol,Kool Jacob,Mascola Laurene,Jarvis William R.
Abstract
Objective:To identify risk factors associated with an unexpected outbreak of pyrogenic reactions (PR) following intravenous gentamicin.Design:We conducted two cohort studies. PRs were defined as chills, rigors, or shaking within 3 hours after initiating the gentamicin infusion during the preepidemic (December 1, 1997-January 15,1998) or epidemic (May 1-June 15,1998) periods. We tested gentamicin vials for endotoxin using the limulus amebocyte lysate assay.Setting:Inpatient services of a large community hospital in Los Angeles, California.Results:During the epidemic period, 22 (15%) of 152 patients developed documented PRs following intravenous gentamicin. PRs were more likely among patients receiving single daily dosing (SDD) than multiple daily dosing gentamicin (20/73 [27%] vs 2/79 [3%]; relative risk, 10.8; 95% confidence interval, 2.644.7). Laboratory analysis of gentamicin vials found endotoxin levels that were higher among Fujisawa-brand gentamicin (implicated brand) than gentamicin used after the outbreak terminated (non-implicated brand). Although endotoxin levels in the vials did not exceed US Pharmacopeia limits (1.7 endotoxin units/mg gentamicin), the use of SDD gentamicin may place patients at greater risk of receiving doses of endotoxin above the threshold for PRs in humans.Conclusions:Reassessment of the acceptable amounts of endotoxin in gentamicin and other parenteral products should be considered when dosing intervals used in clinical practice change.
Publisher
Cambridge University Press (CUP)
Subject
Infectious Diseases,Microbiology (medical),Epidemiology
Cited by
7 articles.
订阅此论文施引文献
订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献
1. Emerging Immune Context;Endotoxin Detection and Control in Pharma, Limulus, and Mammalian Systems;2019
2. Gentamicin;Meyler's Side Effects of Drugs;2016
3. ANTIBACTERIAL DRUGS;Meyler's Side Effects of Antimicrobial Drugs;2010
4. Gentamicin;Meyler's Side Effects of Drugs: The International Encyclopedia of Adverse Drug Reactions and Interactions;2006
5. Endotoxin-Like Reactions With Intravenous Gentamicin Results From Pharmacovigilance Tools Under Investigation;Infection Control & Hospital Epidemiology;2005-04