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Multiplex Therapeutic Drug Monitoring by Isotope-dilution HPLC-MS/MS of Antibiotics in Critical Illnesses
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Delirium Associations with Antibiotics: A Pharmacovigilance Study of the FDA Adverse Event Reporting System (FAERS)

Chengwen Teng1, Christopher R Frei2,3,4,5

  • 1Department of Clinical Pharmacy and Outcomes Sciences, College of Pharmacy, The University of South Carolina, 715 Sumter Street, Columbia, SC, 29208, USA. TENGC@mailbox.sc.edu.

Drugs - Real World Outcomes
|July 18, 2021
PubMed
Abstract

Insights

This study analyzed FDA Adverse Event Reporting System data and found that several antibiotics, including ertapenem and cefepime, are significantly associated with an increased risk of delirium. This highlights the importance of monitoring for delirium when prescribing these medications.

Area of Science:

  • Pharmacovigilance and Drug Safety
  • Clinical Pharmacology
  • Neuroscience and Neurology

Background:

  • Delirium is a known adverse effect of certain antibiotics, but a comprehensive comparison across many agents is lacking.
  • Previous observations linked specific antibiotics like ertapenem, cefepime, and levofloxacin to delirium.
  • The need for systematic evaluation of antibiotic-associated delirium risk is critical for patient safety.

Purpose of the Study:

  • To systematically evaluate the association between various antibiotics and the risk of delirium.
  • To utilize the FDA Adverse Event Reporting System (FAERS) database for a large-scale analysis.
  • To quantify the reporting odds ratios (RORs) for delirium associated with different antibiotic classes.

Main Methods:

  • Analysis of FDA Adverse Event Reporting System (FAERS) data from January 1, 2004, to December 31, 2018.
  • Calculation of reporting odds ratios (RORs) and 95% confidence intervals (95% CIs) to assess the strength of association.
  • Statistical significance determined by a lower limit of the 95% CI greater than 1.0.

Main Results:

  • Over 10 million reports were analyzed, including nearly 17,000 delirium reports.
  • Significant associations with delirium were found for ertapenem (ROR 21.07), cefepime (ROR 9.8), imipenem (ROR 9.68), and ofloxacin (ROR 7.73).
  • Other antibiotics with significant associations include ceftazidime, clarithromycin, cefaclor, ampicillin-sulbactam, levofloxacin, linezolid, moxifloxacin, azithromycin, piperacillin-tazobactam, trimethoprim-sulfamethoxazole, metronidazole, ciprofloxacin, and cefuroxime.

Conclusions:

  • This study confirms and quantifies the increased risk of delirium associated with a broad range of commonly prescribed antibiotics.
  • Ertapenem, cefepime, imipenem, and ofloxacin demonstrated the highest reporting odds ratios for delirium.
  • Findings underscore the necessity for clinicians to be vigilant about potential delirium when prescribing these antibiotics.

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