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Pyrogenic reactions associated with single daily dosing of intravenous gentamicin

U Buchholz1, C Richards, R Murthy

  • 1Epidemic Intelligence Service, Epidemiology Program Office, Centers for Disease Control and Prevention, Atlanta, Georgia 30333, USA.

Infection Control and Hospital Epidemiology
|January 5, 2001
PubMed
Abstract

Insights

An unexpected outbreak of pyrogenic reactions (PR) occurred with intravenous gentamicin. Single daily dosing (SDD) increased PR risk, possibly due to higher endotoxin exposure, necessitating a review of endotoxin limits in parenteral products.

Area of Science:

  • Pharmacology and Toxicology
  • Infectious Disease and Microbiology
  • Clinical Pharmacy

Background:

  • Pyrogenic reactions (PR) are adverse events that can occur following parenteral administration of medications.
  • Gentamicin, an aminoglycoside antibiotic, is commonly administered intravenously for serious bacterial infections.
  • Understanding risk factors for unexpected outbreaks of PR is crucial for patient safety.

Purpose of the Study:

  • To investigate the risk factors associated with an unpredicted outbreak of pyrogenic reactions (PR) linked to intravenous gentamicin administration.
  • To identify specific gentamicin formulations or dosing regimens contributing to the observed increase in PRs.

Main Methods:

  • Conducted two-period cohort studies (pre-epidemic and epidemic) at a community hospital in Los Angeles.
  • Defined PRs as chills, rigors, or shaking within 3 hours post-gentamicin infusion.
  • Assayed gentamicin vials for endotoxin levels using the limulus amebocyte lysate assay.

Main Results:

  • During the epidemic period, 15% of patients receiving intravenous gentamicin developed PRs.
  • Patients on single daily dosing (SDD) had a significantly higher risk of PRs (27%) compared to multiple daily dosing (3%).
  • Higher endotoxin levels were detected in the implicated Fujisawa-brand gentamicin vials, although within US Pharmacopeia limits.

Conclusions:

  • Single daily dosing of gentamicin may increase the risk of pyrogenic reactions by potentially exceeding safe endotoxin thresholds.
  • Re-evaluation of acceptable endotoxin limits in parenteral products is warranted, especially with changes in clinical dosing intervals.
  • This study highlights the importance of monitoring drug quality and administration practices to prevent adverse events.

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