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 November 2025 | Viewed by 799

Special Issue Editors


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Guest Editor
Pharmacovigilance Unit, Faculty of Health Sciences, University of Beira Interior, Covilhã, Portugal
Interests: pharmacovigilance; drug safety; adverse drug reactions

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Guest Editor
CICS—Health Sciences Research Center, Faculty of Health Sciences, University of Beira Interior, 6201-001 Covilhã, Portugal
Interests: design of bioactive compounds; chemical synthesis; biological evaluation; compounds with medicinal and pharmaceutical interests
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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

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Keywords

  • adverse drug reaction
  • pharmacovigilance
  • drug safety
  • signal detection
  • risk management

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Published Papers (1 paper)

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Research

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
Viewed by 591
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
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