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Pharmaceuticals
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Pharmacovigilance Insights: Addressing Drug Misuse and Enhancing Drug Safety
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Pharmacovigilance Insights: Addressing Drug Misuse and Enhancing Drug Safety

A special issue of Pharmaceuticals (ISSN 1424-8247). This special issue belongs to the section "Pharmacology".

Deadline for manuscript submissions: 25 April 2026 | Viewed by 8339

Special Issue Editors

Dr. Cristina Sofia De Jesus Monteiro

E-Mail Website
Guest Editor
Pharmacovigilance Unit, Faculty of Health Sciences, University of Beira Interior, Covilhã, Portugal
Interests: pharmacovigilance; drug safety; adverse drug reactions
Prof. Dr. Samuel Martins Silvestre

E-Mail Website
Guest Editor
RISE-Health, Faculty of Sciences, University of Beira Interior, Rua Marquês d'Ávila e Bolama, 6201-001 Covilhã, Portugal
Interests: design of bioactive compounds; chemical synthesis; biological evaluation; compounds with medicinal and pharmaceutical interests
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

The evolution of pharmacovigilance is increasingly challenged by phenomena such as drug misuse, off-label use and medication errors, all of which can be linked to underlying pharmacological mechanisms. These issues not only pose a significant risk to patient safety but also emphasise the importance of understanding how pharmacodynamic and pharmacokinetic factors contribute to adverse drug reactions (ADRs) and treatment failures. This Special Issue, entitled “Insights into Pharmacovigilance: Addressing Drug Misuse and Enhancing Drug Safety”, seeks contributions that explore the pharmacological basis of drug safety issues and propose mechanism-based approaches to improve pharmacovigilance systems. We invite original research articles and systematic reviews that go beyond observational data to investigate molecular targets, receptor interactions, metabolic pathways, drug–drug interactions or genetic polymorphisms that may affect drug safety.By linking pharmacological insights with regulatory and clinical perspectives, this Special Issue aims to provide a science-based framework for the optimisation of post-market surveillance and the advancement of drug safety science.

Dr. Cristina Sofia De Jesus Monteiro
Dr. Samuel Martins Silvestre
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-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Pharmaceuticals 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 2900 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 reaction
  • pharmacovigilance
  • drug safety
  • signal detection
  • risk management

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Published Papers (5 papers)

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Research

23 pages, 1835 KB  
Article
Divergent System Organ Class Safety Profiles of Isotretinoin Versus Topical Retinoids: An EudraVigilance Disproportionality Analysis
by Denisa Viola Szilagyi, Delia Mirela Tit, Ruxandra Cristina Marin, Gabriela S. Bungau, Mirela Marioara Toma, Manuela Bianca Pasca, Daniela Gitea and Laura Maria Endres
Pharmaceuticals 2026, 19(1), 127; https://doi.org/10.3390/ph19010127 - 11 Jan 2026
Viewed by 352
Abstract
Background/Objectives: Isotretinoin remains an essential therapy for severe acne, yet its safety profile continues to raise concerns. This study analyzed adverse event reporting patterns for isotretinoin versus topical retinoids using EudraVigilance data. Methods: Aggregated ADR data for isotretinoin and four topical retinoids (tretinoin, [...] Read more.
Background/Objectives: Isotretinoin remains an essential therapy for severe acne, yet its safety profile continues to raise concerns. This study analyzed adverse event reporting patterns for isotretinoin versus topical retinoids using EudraVigilance data. Methods: Aggregated ADR data for isotretinoin and four topical retinoids (tretinoin, adapalene, tazarotene, trifarotene) were retrieved from the EMA ADRreports portal (April 2025). Disproportionality was assessed using reporting odds ratios (RORs) with 95% confidence intervals at the MedDRA system organ class (SOC) level. Significant demographic differences (age and sex; both p < 0.001) justified stratified ROR analyses for SOCs showing positive signals. Results: Among 35,030 isotretinoin and 3795 topical retinoid reports, isotretinoin showed strong over-reporting in six SOCs: psychiatric disorders (ROR 11.96; 95% CI 10.11–14.14), gastrointestinal disorders (3.88; 3.50–4.31), musculoskeletal and connective tissue disorders (2.89; 2.50–3.35), surgical and medical procedures, social circumstances, and ear and labyrinth disorders. Fourteen SOCs demonstrated significant under-reporting, including neoplasms, immune system disorders, cardiac disorders, and blood/lymphatic disorders. Stratified analyses confirmed the robustness of the positive signals. Psychiatric disorders exhibited the highest disproportionality in males (22.10; 16.11–30.31) and adolescents aged 12–17 (25.85; 13.32–50.19). Gastrointestinal and musculoskeletal signals remained significant across all age and sex strata. Conclusions: Isotretinoin presents a distinct safety profile characterized by consistently elevated reporting of psychiatric, gastrointestinal, and musculoskeletal adverse events, independent of age and sex. These results refine the comparative safety landscape of systemic versus topical retinoids and support focused pharmacovigilance monitoring. Full article
(This article belongs to the Special Issue Pharmacovigilance Insights: Addressing Drug Misuse and Enhancing Drug Safety)
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17 pages, 406 KB  
Article
Balancing Pain Relief and Safety: Gastrointestinal and Cardiovascular Risk Assessment in Nonsteroidal Anti-Inflammatory Drug Users and the Role of Gastroprotective Co-Therapy
by Javedh Shareef, Sathvik Belagodu Sridhar, Zainab Mohamed Saeed and Amal Mohamed Rashed Alsereidi
Pharmaceuticals 2026, 19(1), 67; https://doi.org/10.3390/ph19010067 - 29 Dec 2025
Viewed by 548
Abstract
Background/Objectives: Nonsteroidal anti-inflammatory drugs (NSAIDs) are widely used for pain management but pose gastrointestinal (GI) and cardiovascular (CV) risks, particularly during long-term use. This study evaluated NSAID-prescribing patterns and the appropriateness of gastroprotective co-therapy among patients with varying GI and CV risk [...] Read more.
Background/Objectives: Nonsteroidal anti-inflammatory drugs (NSAIDs) are widely used for pain management but pose gastrointestinal (GI) and cardiovascular (CV) risks, particularly during long-term use. This study evaluated NSAID-prescribing patterns and the appropriateness of gastroprotective co-therapy among patients with varying GI and CV risk profiles. Methods: An observational, cross-sectional study was conducted in the outpatient pharmacy department over six months (March 2023 to August 2023) at a public secondary care facility. Data pertaining to patient demographics, NSAIDs prescription, and GI/CV risks were collected and reviewed from electronic health records. Descriptive statistics, chi-square tests, and logistic regression were performed. Results: A total of 1005 prescriptions containing 2051 NSAIDs were analyzed. Selective COX-2 inhibitors and non-selective NSAIDs were the most frequently prescribed. Only 42.1% of patients received proton-pump inhibitors despite guideline recommendations. Non-selective NSAIDs were significantly associated with CV history and GI risk (p < 0.0001). Logistic regression showed age, gender, CV history, and GI risk significantly influenced NSAID selection. Notably, non-selective NSAIDs continued to be prescribed among moderate- and high-GI-risk patients. Conclusions: Suboptimal adherence to guideline-recommended gastroprotective strategies was evident, particularly among high-risk patients. Comprehensive GI and CV risk assessment and the rational use of gastroprotective co-therapy are essential. Integrating evidence-based digital tools may enhance safer NSAID prescribing in routine practice. Full article
(This article belongs to the Special Issue Pharmacovigilance Insights: Addressing Drug Misuse and Enhancing Drug Safety)
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18 pages, 480 KB  
Article
Safety of Drugs Used in Difficult-to-Treat Epileptic Syndromes: A Disproportionality Analysis Using the Eudravigilance Database
by Arianna Scala, Teresa Angela Trunfio, Chiara Pennisi, Giovanni Enrico Lombardo, Vincenzo Micale, Serena Di Martino, Giorgia Fiorenza, Adriana Carol Eleonora Graziano, Marilena Briglia, Fabio Allia, Giovanni Giurdanella, Roberta Malaguarnera, Rosalia Battaglia, Cecilia Gozzo, Fanny Erika Palumbo, Calogero Vetro, Giovanni Improta, Mario Damiano Toro, Filippo Drago, Giovanni Luca Romano and Lucia Gozzoadd Show full author list remove Hide full author list
Pharmaceuticals 2025, 18(12), 1895; https://doi.org/10.3390/ph18121895 - 16 Dec 2025
Viewed by 671
Abstract
Background/Objectives: Difficult-to-treat epileptic syndromes include conditions typically emerging in the first years of life and are characterized by a high rate of drug refractoriness. This study aimed to better define the safety profile of drugs used as adjunctive therapies for seizures associated [...] Read more.
Background/Objectives: Difficult-to-treat epileptic syndromes include conditions typically emerging in the first years of life and are characterized by a high rate of drug refractoriness. This study aimed to better define the safety profile of drugs used as adjunctive therapies for seizures associated with these syndromes using real-world pharmacovigilance data. Methods: We retrospectively analyzed the publicly available data regarding Individual Case Safety Reports (ICSRs), presenting stiripentol, cannabidiol, or fenfluramine as suspected drugs, reported on the Eudravigilance database until the third quarter of 2024. Data were evaluated with descriptive analyses and then with disproportionality measures, including the reporting odds ratio. Results: A total of 5986 ICSRs met the inclusion criteria (71.6% from cannabidiol, 14.5% fenfluramine, and 13.9% stiripentol). Significantly higher probabilities of reporting Cardiac disorders, Vascular disorders, and Respiratory, thoracic, and mediastinal disorders were observed with fenfluramine. Cannabidiol was associated with Product issues, whereas stiripentol was associated with injury, poisoning, procedural complications, Metabolism and nutrition disorders, and Blood and lymphatic system disorders. Conclusions: Our analysis did not highlight new and unexpected serious safety signals but confirmed the need to strictly monitor patients for the risk of adverse events. However, further prospective studies are required to better clarify the safety profile of these drugs in order to optimize their use. Full article
(This article belongs to the Special Issue Pharmacovigilance Insights: Addressing Drug Misuse and Enhancing Drug Safety)
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19 pages, 1157 KB  
Article
Prescribed Drugs and Interpersonal Violence: A Case–Non-Case Study in the Spanish Pharmacovigilance Database
by Ana Avedillo-Salas, Ana Fanlo-Villacampa, Francisco Javier Lanuza-Giménez and Jorge Vicente-Romero
Pharmaceuticals 2025, 18(12), 1845; https://doi.org/10.3390/ph18121845 - 3 Dec 2025
Viewed by 777
Abstract
Background/Objectives: Interpersonal violence is an increasing public health concern, and its prediction and prevention remain global challenges. This study aimed to identify prescribed medications associated with interpersonal violence in Spain. Methods: A descriptive, longitudinal and retrospective study and case-non case study of [...] Read more.
Background/Objectives: Interpersonal violence is an increasing public health concern, and its prediction and prevention remain global challenges. This study aimed to identify prescribed medications associated with interpersonal violence in Spain. Methods: A descriptive, longitudinal and retrospective study and case-non case study of spontaneous reports of adverse drug reactions corresponding to interpersonal violence recorded in the Spanish Pharmacovigilance Database (FEDRA®) from 1984 to 31 March 2021. Results: 533 cases were reported in the study period. The mean age was 46.70 years with ages ranging from 1 to 99 years. There were no sex differences except in child and adolescent age group where most reports were from male. Main therapeutic groups involved were nervous system (62.3%), anti-infectives for systemic use (10%) and respiratory system (8.6%). Mostly drugs reported were montelukast, levetiracetam, bupropion, donepezil, perampanel, quetiapine, fluoxetine, and lorazepam. A statistically significant association/disproportion in the notification has been found in the reporting of interpersonal violence and different drugs according to the literature, notably atomoxetine, perampanel, memantine, donepezil, montelukast and methylphenidate. Conclusions: The results highlight that interpersonal violence, while rare, could occur as a clinically relevant adverse reaction to a small subset of medications. They underscore the importance of careful prescribing, especially in vulnerable populations and in individuals with a history of psychiatric disorders. Full article
(This article belongs to the Special Issue Pharmacovigilance Insights: Addressing Drug Misuse and Enhancing Drug Safety)
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25 pages, 1030 KB  
Article
Real-World Evidence of Neuropsychiatric Adverse Reactions to Isotretinoin: Insights from EudraVigilance (2005–2025)
by Denisa Viola Szilagyi, Delia Mirela Tit, Claudia Teodora Judea-Pusta, Andrei-Flavius Radu, Gabriela S. Bungau, Ada Radu, Laura Maria Endres and Ruxandra-Cristina Marin
Pharmaceuticals 2025, 18(9), 1252; https://doi.org/10.3390/ph18091252 - 24 Aug 2025
Cited by 2 | Viewed by 5340
Abstract
Background/Objectives: Isotretinoin is a highly effective therapy for severe acne, but its potential neuropsychiatric adverse reactions (NPsRs) have been controversial. This study evaluated EudraVigilance data from 2005 to 2025 to better understand the frequency, typology, and predictors of such events. Methods: We conducted [...] Read more.
Background/Objectives: Isotretinoin is a highly effective therapy for severe acne, but its potential neuropsychiatric adverse reactions (NPsRs) have been controversial. This study evaluated EudraVigilance data from 2005 to 2025 to better understand the frequency, typology, and predictors of such events. Methods: We conducted a retrospective analysis of 33,381 individual case safety reports (ICSRs) related to isotretinoin. Using descriptive statistics, chi-square tests, and logistic regression, we assessed associations between NPsRs and variables such as age, sex, geographic region, and reporter type. Results: A total of 9793 cases (29.3%) involved at least one NPsR. Depression (31%) and suicidal ideation (8.6%) were the most frequently reported symptoms. Adolescents (12–17 years) had the highest proportion of NPsR cases, while male patients and reports submitted by non-healthcare professionals were significantly overrepresented. Reports from non-European Economic Area countries also had slightly increased odds of including NPsRs. All predictors were statistically significant in the logistic regression model, though the explained variance was modest (Nagelkerke R2 = 0.065). Conclusions: Neuropsychiatric reactions remain a prominent and persistent signal in isotretinoin pharmacovigilance, particularly among younger patients and non-professional reporters. Although causality cannot be inferred from spontaneous reporting data and confounding factors like acne-related depression cannot be excluded, these findings highlight the clinical value of pre-treatment psychiatric screening, patient-centered education, and proactive mental health monitoring throughout isotretinoin therapy. Full article
(This article belongs to the Special Issue Pharmacovigilance Insights: Addressing Drug Misuse and Enhancing Drug Safety)
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