Adverse Drug Reactions Relevant to Drug Resistance and Ineffectiveness Associated with Meropenem, Linezolid, and

Bogdan Ioan Vintila1,2, Anca Maria Arseniu3, Anca Butuca3

  • 1Clinical Surgical Department, Faculty of Medicine, "Lucian Blaga" University of Sibiu, 550169 Sibiu, Romania.

Insights

Antimicrobial resistance (AMR) poses a significant public health threat. Pharmacovigilance, through analyzing adverse drug reaction reports, can detect potential drug resistance or ineffectiveness, aiding in better patient outcomes in intensive care units.

Area of Science:

  • Pharmacovigilance and Drug Safety
  • Infectious Diseases and Public Health
  • Critical Care Medicine

Background:

  • Antimicrobial resistance (AMR) is a critical global health challenge, particularly impacting intensive care unit (ICU) patient outcomes.
  • Pharmacovigilance systems, utilizing spontaneous adverse drug reaction (ADR) reports, are vital for identifying potential drug resistance (DR) and drug ineffectiveness (DI).

Purpose of the Study:

  • To analyze ADRs associated with meropenem, colistin, and linezolid, focusing on DR and DI signals.
  • To evaluate the reporting frequency of DR and DI for these specific antibiotics compared to other antimicrobials using disproportionality analysis.

Main Methods:

  • Descriptive analysis of Individual Case Safety Reports (ICSRs) from EudraVigilance up to December 31, 2022.
  • Focus on ADRs related to meropenem, colistin, and linezolid, specifically identifying DR and DI.
  • Disproportionality analysis to compare reporting rates of DR/DI for the studied antibiotics against other antimicrobials.

Main Results:

  • ADRs related to DR and DI constituted 2.38–8.42% and 4.15–10.14% of total reported ADRs for the analyzed antibiotics, respectively.
  • Disproportionality analysis indicated specific reporting patterns for DR and DI concerning meropenem, colistin, and linezolid.

Conclusions:

  • Post-marketing drug safety monitoring is crucial for detecting early warning signals of antimicrobial resistance.
  • Identifying DR and DI through pharmacovigilance can contribute to reducing antibiotic treatment failures in critical care settings.

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