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Updated: Jul 29, 2025

Multiplex Therapeutic Drug Monitoring by Isotope-dilution HPLC-MS/MS of Antibiotics in Critical Illnesses
Published on: August 30, 2018
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.
Abstract:
Antimicrobial resistance is considered one of the major threats to public health and is an important factor that influences the patient's outcome in the intensive care unit. Pharmacovigilance can help raise awareness of potential drug resistance (DR) or ineffectiveness (DI) through adverse drug reaction reports that are submitted to different spontaneous reporting systems. Based on spontaneous Individual Case Safety Reports from EudraVigilance, we conducted a descriptive analysis of adverse drug reactions associated with meropenem, colistin, and linezolid, with a focus on DR and DI. Of the total adverse drug reactions (ADRs) reported for each analyzed antibiotic by 31 December 2022, between 2.38-8.42% and 4.15-10.14% of the reports were related to DR and DI, respectively. A disproportionality analysis was conducted to evaluate the frequency of reporting adverse drug reactions relevant to the DR and DI of the analyzed antibiotics compared to other antimicrobials. Based on the analysis of the collected data, this study underlines the importance of post-marketing drug safety monitoring in raising a warning signal regarding antimicrobial resistance, thereby potentially contributing to the reduction in antibiotic treatment failure in an intensive care setting.
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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