Search for Articles:
Title / Keyword
Author / Affiliation / Email
Journal
Article Type
 
 
Advanced Search
 
Section
Special Issue
Volume
Issue
Number
Page
 
7.1
3.9
Journals
Life
Special Issues
Drug Safety
share announcement

Drug Safety

A special issue of Life (ISSN 2075-1729). This special issue belongs to the section "Pharmaceutical Science".

Deadline for manuscript submissions: 31 March 2027 | Viewed by 1702

Editors

Dr. Andrej Belančić

E-Mail Website
Guest Editor
Department of Basic and Clinical Pharmacology and Toxicology, Faculty of Medicine, University of Rijeka, Rijeka, Croatia
Interests: cardiometabolic diseases; clinical pharmacology; evidence-based medicine; pharmacoeconomics; pharmacovigilance; real-world evidence
Special Issues, Collections and Topics in MDPI journals
Prof. Dr. Slobodan Jankovic

E-Mail Website
Guest Editor
Department of Pharmacology and Toxicology, Faculty of Medical Sciences, University of Kragujevac, Kragujevac, Serbia
Interests: clinical pharmacology; evidence-based medicine; pharmacoeconomics; pharmacovigilance

Special Issue Information

Dear Colleagues,

In the Special Issue titled ‘Drug Safety’, we aim to present current advances and emerging perspectives in the field of drug safety, with a particular emphasis on its role within clinical and translational research. This Special Issue, edited by Dr. Andrej Belančić and Prof. Slobodan Janković, will explore the complex and multifactorial nature of drug safety and its integration into modern research environments.

We welcome contributions from a wide array of fields, including clinical medicine, pharmacology, pharmacy, and translational research. Topics of interest include, but are not limited to, adverse drug reactions, pharmacovigilance, drug interactions, and medication safety in clinical practice. Particular emphasis will be placed on translational approaches that bridge basic pharmacological research and clinical application, including the use of biomarkers, personalized medicine, and innovative methodologies in drug safety assessment.

This Special Issue seeks to gather novel findings and expert perspectives that will advance our understanding of drug safety in both research and clinical settings. We believe that Life provides an excellent platform for multidisciplinary discussion, facilitating the integration of translational science and clinical practice. We hope this Special Issue will attract researchers and clinicians, and serve as a valuable resource for those involved in improving medication safety and patient outcomes.

If you are interested in contributing an article that fits the scope of this Special Issue, please feel free to contact the Guest Editors or the Editorial Board. We look forward to your submissions and to a fruitful collaboration.

Dr. Andrej Belančić
Prof. Dr. Slobodan Jankovic
Guest Editors

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 250 words) can be sent to the Editorial Office for assessment.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-anonymized peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Life is an international peer-reviewed open access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2600 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • adverse drug reactions
  • drug safety
  • pharmacovigilance
  • drug interactions
  • signal detection
  • personalized medicine

Benefits of Publishing in a Special Issue

  • Ease of navigation: Grouping papers by topic helps scholars navigate broad scope journals more efficiently.
  • Greater discoverability: Special Issues support the reach and impact of scientific research. Articles in Special Issues are more discoverable and cited more frequently.
  • Expansion of research network: Special Issues facilitate connections among authors, fostering scientific collaborations.
  • External promotion: Articles in Special Issues are often promoted through the journal's social media, increasing their visibility.
  • Reprint: MDPI Books provides the opportunity to republish successful Special Issues in book format, both online and in print.

Further information on MDPI's Special Issue policies can be found here.

Published Papers (5 papers)

Download All Papers
Order results
Result details
Show export options expand_more Show export options expand_less
Select all
Export citation of selected articles as:

Research

Jump to: Review

13 pages, 894 KB  
Article
Increased Prevalence of Multidrug-Resistant Escherichia coli as an Adverse Effect of Excessive Antibiotic Use in a Tertiary Care Hospital in Serbia
by Vladimir Zivanovic, Teodora Vitorovic, Dejan Stojakov, Biljana Carevic, Ana Bukarica, Ilija Doknic and Ljiljana Gojkovic Bukarica
Life 2026, 16(9), 1392; https://doi.org/10.3390/life16091392 - 24 Aug 2026
Abstract
One of the most important adverse consequences of antibiotic use is the development of bacterial resistance. This study investigated the prevalence and antimicrobial resistance patterns of multidrug-resistant (MDR) Escherichia coli in a tertiary care hospital during 2013–2015 and 2024, together with trends in [...] Read more.
One of the most important adverse consequences of antibiotic use is the development of bacterial resistance. This study investigated the prevalence and antimicrobial resistance patterns of multidrug-resistant (MDR) Escherichia coli in a tertiary care hospital during 2013–2015 and 2024, together with trends in antibiotic consumption and the molecular characteristics of resistance genes in 2024 isolates. Identification and susceptibility testing were performed using the Vitek® 2 system, antibiotic consumption was assessed according to WHO ATC/DDD methodology, and resistance genes were detected by PCR. No significant differences were observed in the total number of isolates, patients, or the proportion of E. coli isolates during 2013–2015. However, the isolation rate of MDR E. coli significantly declined from 36.9% to 30%. Total antibiotic consumption remained stable, with no correlation between consumption and MDR isolation rates, although ampicillin resistance increased significantly. In 2024, MDR E. coli accounted for 24.3% of isolates despite lower antibiotic consumption. Compared with 2015, resistance significantly increased to amoxicillin–clavulanic acid, cefotaxime, cefepime, ceftazidime, ciprofloxacin, and levofloxacin, while ceftriaxone resistance decreased. The blaCTX-M gene was detected in 53% of bloodstream isolates, indicating widespread dissemination of ESBL-producing E. coli and highlighting the need for continuous surveillance and antimicrobial stewardship. Full article
(This article belongs to the Special Issue Drug Safety)
►▼ Show Figures

Figure 1

12 pages, 1610 KB  
Article
Late-Onset Neutropenia and Hypogammaglobulinemia After Dose-Adjusted R-EPOCH in Unfavorable Diffuse Large B-Cell Lymphoma
by Marko Lucijanić, Rafaela Filipan, Martina Sedinić Lacko, Marija Ivić Čikara, Zdravko Mitrović and Ozren Jakšić
Life 2026, 16(9), 1388; https://doi.org/10.3390/life16091388 - 23 Aug 2026
Viewed by 132
Abstract
Background: Late-onset neutropenia (LON) and hypogammaglobulinemia are recognized sequelae of rituximab therapy in B-cell non-Hodgkin lymphoma, and both may leave patients vulnerable to infection once treatment has ended. Methods: Fifty-three patients with newly diagnosed, unfavorable diffuse large B-cell lymphoma (DLBCL) who entered remission [...] Read more.
Background: Late-onset neutropenia (LON) and hypogammaglobulinemia are recognized sequelae of rituximab therapy in B-cell non-Hodgkin lymphoma, and both may leave patients vulnerable to infection once treatment has ended. Methods: Fifty-three patients with newly diagnosed, unfavorable diffuse large B-cell lymphoma (DLBCL) who entered remission on dose-adjusted (DA) R-EPOCH immunochemotherapy were retrospectively evaluated. Neutropenia (absolute neutrophil count < 1.5 × 109/L, CTCAE-graded), hypogammaglobulinemia and infections were registered at treatment completion and 6 and 12 months later. Results: All laboratory parameters changed significantly over time. Most reached their nadir at the end of treatment, whereas the absolute neutrophil count alone reached its lowest value later, at 6 months. Neutropenia, largely mild to moderate, affected 17.6% of patients at treatment completion, 22.4% at 6 months and 7.9% at 12 months. Neutropenia at 6 months was a new event, with no overlap with end-of-treatment neutropenia, and was mostly transient. Hypogammaglobulinemia (IgG < 5 g/L) occurred in 33.3%, 16.7% and 20.0%, respectively; median IgG declined to a nadir at the end of treatment and recovered thereafter, although the deficit tended to persist in the same patients. Post-treatment infections were recorded in 73.6% of patients (mostly respiratory); neutropenia was not associated with infection at any time point, whereas end-of-treatment hypogammaglobulinemia was associated with respiratory infection (p = 0.040). The independent predictors of 6-month neutropenia were a greater number of dose-escalated cycles, lower baseline leukocyte count and the absence of on-treatment infection, whereas 6-month hypogammaglobulinemia was predicted by autologous transplantation and the absence of B symptoms. In exploratory body composition analyses, lower baseline psoas muscle mass was associated with end-of-treatment neutropenia (p = 0.042) and greater muscle loss with other site (skin and gastrointestinal) infection (p = 0.004). Conclusions: After DA-R-EPOCH, LON is a delayed and largely transient event separate from end-of-treatment neutropenia, whereas hypogammaglobulinemia is more persistent and clinically relevant for respiratory infections. Full article
(This article belongs to the Special Issue Drug Safety)
►▼ Show Figures

Figure 1

13 pages, 238 KB  
Article
Potentially Clinically Relevant Drug–Drug Interactions in Oncology Patients Receiving Chronic Opioid Therapy: Prevalence and Associated Factors
by Gorana Nedin Ranković, Dane Krtinić, Aleksandar Nikolić, Ana Cvetanović, Mirjana Todorović Mitić, Milica Mihajlović, Irena Conić, Nikola Milenković, Nemanja Dimić, Nada Pejčić and Iva Binić
Life 2026, 16(8), 1280; https://doi.org/10.3390/life16081280 - 2 Aug 2026
Viewed by 325
Abstract
Background: Patients with malignant diseases receiving chronic opioid therapy are particularly susceptible to drug–drug interactions because of extensive polypharmacy, multimodal anticancer treatment, supportive care, and comorbidities. This study aimed to determine the prevalence of potentially clinically relevant drug–drug interactions and to identify factors [...] Read more.
Background: Patients with malignant diseases receiving chronic opioid therapy are particularly susceptible to drug–drug interactions because of extensive polypharmacy, multimodal anticancer treatment, supportive care, and comorbidities. This study aimed to determine the prevalence of potentially clinically relevant drug–drug interactions and to identify factors associated with their occurrence. Methods: This exploratory observational cross-sectional pilot study included 49 adult oncology patients receiving chronic opioid therapy. Complete medication regimens were screened using the Medscape Drug Interaction Checker and Lexicomp. Lexicomp category D and X interactions were analysed descriptively. Because category D interactions were nearly universal and category X interactions were rare, the presence of at least one Medscape “Serious—Use Alternative” interaction was used pragmatically as the binary outcome for regression modelling. Potential predictors were assessed using univariable binary logistic regression and a parsimonious adjusted model with covariates selected using a clinically informed approach. Because of quasi-complete separation, Firth’s penalized-likelihood logistic regression was used as the primary adjusted analysis. Results: Lexicomp category D interactions were identified in 48 of 49 patients (98.0%), whereas category X interactions were present in 2 patients (4.1%). Medscape serious interactions were detected in 33 patients (67.3%). In the Firth-adjusted model, female sex was associated with lower odds of a Medscape serious interaction (adjusted OR 0.12, 95% CI 0.02–0.52), while cardiovascular disease was associated with higher odds (adjusted OR 5.16, 95% CI 1.27–26.31). Stage IV disease showed a positive but statistically non-significant association, and total medication count was not independently associated with the outcome in sensitivity analysis. Because of the small pilot sample and the resulting wide confidence intervals, these findings should be interpreted as exploratory and hypothesis-generating. Conclusions: Oncology patients receiving chronic opioid therapy had a high burden of potentially clinically relevant drug–drug interactions, predominantly Lexicomp category D interactions, warranting consideration of therapy modification and individualized monitoring rather than absolute avoidance. Regular medication review, use of complementary interaction databases, and individualized clinical assessment may improve pharmacotherapy safety in this vulnerable population. Full article
(This article belongs to the Special Issue Drug Safety)
17 pages, 1928 KB  
Article
Drug-Associated Vanishing Bile Duct Syndrome: Screening for Potential Pharmaceutical Triggers Using the WHO Pharmacovigilance Database
by João Pereira Soares, Andreas E. Kremer and Jérôme Bonzon
Life 2026, 16(8), 1232; https://doi.org/10.3390/life16081232 - 25 Jul 2026
Cited by 1 | Viewed by 537
Abstract
Vanishing bile duct syndrome (VBDS) is a rare cholestatic liver disease often associated with drug-induced liver injury, yet systematic data on pharmaceutical triggers remain limited. Using WHO VigiBase, we applied Bayesian disproportionality analysis (IC0.25) to identify drug-event associations that may not [...] Read more.
Vanishing bile duct syndrome (VBDS) is a rare cholestatic liver disease often associated with drug-induced liver injury, yet systematic data on pharmaceutical triggers remain limited. Using WHO VigiBase, we applied Bayesian disproportionality analysis (IC0.25) to identify drug-event associations that may not be readily apparent in clinical trials or pre-marketing studies. Product labels approved by Swissmedic or the FDA, as well as LiverTox, were reviewed to determine whether VBDS was already acknowledged as an adverse event. Signal detection was deliberately restricted to reports naming a single suspect drug. Among these single-agent reports, 22 drugs demonstrated a positive IC0.25 signal, of which nevirapine, dapsone and azithromycin showed the strongest disproportionality signal. Only one of these agents (carbamazepine) explicitly labelled VBDS as an adverse event. These findings are based on spontaneous reporting data: disproportionality analysis is a hypothesis-generating signal-detection method that does not establish causality and requires further validation. This study expands the current understanding of drug-induced VBDS by reinforcing the associations with known drugs and generating pharmacovigilance signals for new potential VBDS triggers across several drug categories. Full article
(This article belongs to the Special Issue Drug Safety)
►▼ Show Figures

Figure 1

Review

Jump to: Research

18 pages, 456 KB  
Review
Safety Monitoring of High-Risk Antibiotics Using Artificial Intelligence: A Narrative Review with Focus on Real-World Evidence
by Mila Kostić, Marta Krpan, Paula Bulić, Martin Bobek, Jakov Kožić and Robert Likić
Life 2026, 16(7), 1158; https://doi.org/10.3390/life16071158 - 13 Jul 2026
Viewed by 367
Abstract
High-risk antibiotics remain indispensable in contemporary infectious diseases practice, yet they account for a disproportionate share of preventable toxicity, therapeutic drug monitoring complexity, and antimicrobial stewardship workload. Vancomycin, aminoglycosides, colistin, linezolid, daptomycin, selected beta-lactams, and amphotericin B are particularly challenging because clinically relevant [...] Read more.
High-risk antibiotics remain indispensable in contemporary infectious diseases practice, yet they account for a disproportionate share of preventable toxicity, therapeutic drug monitoring complexity, and antimicrobial stewardship workload. Vancomycin, aminoglycosides, colistin, linezolid, daptomycin, selected beta-lactams, and amphotericin B are particularly challenging because clinically relevant exposure-toxicity relationships coexist with marked inter-patient variability and fragmented post-marketing safety surveillance. Artificial intelligence and real-world evidence are increasingly proposed as complementary approaches to address these limitations, although the evidence base remains heterogeneous and predominantly retrospective. This narrative review synthesises literature from PubMed/MEDLINE, Scopus, and Web of Science published between 2019 and April 2026, supplemented by citation chaining and regulatory pharmacovigilance resources, with studies prioritised by implementation maturity, external validation status, and stewardship relevance. Current evidence indicates that artificial intelligence may improve safety monitoring when embedded within clinically rich data environments: machine learning models show promising discrimination for nephrotoxicity and haematological toxicity in vancomycin, colistin, and linezolid therapy; natural language processing may enhance adverse drug event extraction from clinical text; and Bayesian, model-informed tools already demonstrate clinical utility in vancomycin and aminoglycoside dosing. However, prospective implementation data remain sparse, external validation is uncommon, and evidence that these tools improve real-world antibiotic safety outcomes, as opposed to predictive discrimination alone, remains limited. Artificial intelligence-enabled antibiotic safety monitoring is therefore transitioning from methodological promise towards conditional clinical utility rather than proven benefit. Near-term value is most likely to arise from integration with therapeutic drug monitoring, antimicrobial stewardship, and pharmacology-led clinical review rather than autonomous decision-making, with clinical pharmacologists and stewardship teams leading local implementation, validation, and governance of these tools. Full article
(This article belongs to the Special Issue Drug Safety)
►▼ Show Figures

Figure 1

Show export options expand_more Show export options expand_less
Select all
Export citation of selected articles as:
 
Displaying articles 1-5
Back to TopTop