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Pharmaceuticals
Special Issues
Pharmacovigilance in Drug Therapy and Adverse Reactions
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Pharmacovigilance in Drug Therapy and Adverse Reactions

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

Deadline for manuscript submissions: 30 June 2026 | Viewed by 1933

Editor

Dr. Jaime Conceição

E-Mail Website
Guest Editor
Faculty of Sciences and Technology, University of Algarve, Campus de Gambelas, 8005-139 Faro, Portugal
Interests: pharmacotherapy; pharmacovigilance; regulatory affairs; history of pharmacy

Special Issue Information

Dear Colleagues,

Pharmacovigilance is essential for the continuous monitoring of drug safety after marketing authorization has been obtained. This Special Issue, entitled ‘Pharmacovigilance in Drug Therapy and Adverse Reactions’, aims to highlight recent advances and applications in Pharmacovigilance. Authors are invited to submit original and review articles focusing on three primary areas, namely,

  1. Pharmacovigilance and Core Artificial Intelligence Technologies (e.g., machine learning, natural language processing and robotic process automation);
  2. Pharmacovigilance and Biological Medicinal Products (e.g., CAR T-cell therapy, monoclonal antibodies and vaccines);
  3. Pharmacovigilance and High-Impact Diseases (e.g., cancer, diabetes, cardiovascular and respiratory diseases, neurological and mental disorders and infectious diseases).

We look forward to your valuable contributions.

Dr. Jaime Conceição
Guest Editor

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. 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

  • pharmacovigilance
  • adverse reactions
  • drug safety
  • artificial intelligence
  • biological drugs
  • high-impact diseases

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

Published Papers (2 papers)

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Research

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22 pages, 1450 KB  
Article
Impact of Reporter Type on Signal Detection of Cancer Therapy-Induced Alopecia: A Hypothesis-Generating Study Using the FDA Adverse Event Reporting System
by Airi Yajima and Yoshihiro Uesawa
Pharmaceuticals 2026, 19(3), 445; https://doi.org/10.3390/ph19030445 - 10 Mar 2026
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Abstract
Background/Objectives: Cancer therapy-induced alopecia (CTIA) profoundly affects patients’ quality of life. This study conducted a disproportionality analysis of CTIA using the FDA Adverse Event Reporting System (FAERS) database to provide an overview of drug-specific signal distributions by systematically evaluating the impact of [...] Read more.
Background/Objectives: Cancer therapy-induced alopecia (CTIA) profoundly affects patients’ quality of life. This study conducted a disproportionality analysis of CTIA using the FDA Adverse Event Reporting System (FAERS) database to provide an overview of drug-specific signal distributions by systematically evaluating the impact of reporter type on CTIA signal detection. Methods: FAERS data from January 2004 to September 2024 were analyzed to extract alopecia-related Preferred Terms included under the Medical Dictionary for Regulatory Activities High Level Term “Alopecias.” Reporting odds ratios (RORs) were calculated to assess disproportionality. A primary analysis including all reports and a stratified analysis restricted to reports submitted by healthcare professionals (HCPs) were performed. No individual case-level clinical review was conducted. Results: Approximately 90% of alopecia reports were associated with female patients, and approximately 40% of these reports were linked to breast cancer. In the disproportionality analysis including all reporters, the highest ROR [95% confidence interval (CI)] was observed for docetaxel [58.31 (57.46–59.17)]. In the analysis restricted to HCP reports, the highest ROR was observed for vismodegib [23.92 (21.86–26.17)], whereas that for docetaxel markedly decreased to 3.68 (3.48–3.89). For molecular targeted agents, statistically significant signals were maintained even in the HCP-restricted analysis. Conclusions: Reporter characteristics substantially influence the detection of alopecia signals, with patients amplifying signals reflecting psychological harm and HCPs amplifying signals reflecting pharmacological plausibility. These findings should be interpreted as hypothesis-generating and warrant further validation using prospective or clinical datasets. Full article
(This article belongs to the Special Issue Pharmacovigilance in Drug Therapy and Adverse Reactions)
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14 pages, 1282 KB  
Systematic Review
Efficacy and Safety of Octreotide for Gastrointestinal Bleeding Due to Portal Hypertension in Children—A Systematic Review
by Ann Kozak, Grace Nolder, Giusy Ranucci and Alessio Provenzani
Pharmaceuticals 2026, 19(7), 978; https://doi.org/10.3390/ph19070978 (registering DOI) - 24 Jun 2026
Abstract
Background: Portal hypertension can lead to complications such as ascites, hepatic encephalopathy, esophageal varices, and gastrointestinal (GI) bleeding, all of which are associated with significant morbidity and mortality. Variceal bleeding is the most severe complication, with an estimated mortality of up to [...] Read more.
Background: Portal hypertension can lead to complications such as ascites, hepatic encephalopathy, esophageal varices, and gastrointestinal (GI) bleeding, all of which are associated with significant morbidity and mortality. Variceal bleeding is the most severe complication, with an estimated mortality of up to 30%. In children, evidence-based guidelines for the management of GI bleeding secondary to portal hypertension are lacking. In this con-text, octreotide, a synthetic somatostatin analog approved for other indications, has been increasingly used off-label and represents a paradigmatic example of drug re-purposing in pediatrics. Methods: Following the 2020 PRISMA guidelines, this systematic review evaluated the efficacy and safety of octreotide for the treatment of portal hyperten-sion-related GI bleeding in children. A comprehensive search of six sources, including five bibliographic databases (PubMed, Embase, Web of Science, Cochrane Library, and EBSCOhost) and the ClinicalTrials.gov registry, was conducted to identify studies in-cluding pediatric patients with GI bleeding secondary to portal hypertension. Results: Three non-randomized observational studies were included, assessing bleeding recurrence, packed red blood cell requirements, and adverse events following octreotide admin-istration. Overall, 33 patients were analyzed, with a mean age of 6.3 years. One study reported a reduction in rebleeding episodes and transfusion requirements after oc-treotide treatment. Across all included studies, no serious adverse events were ob-served; mild and reversible hyperglycemia was the only reported drug-related effect. Quantitative synthesis was not feasible due to substantial heterogeneity, missing data, and a serious risk of bias, resulting in very low certainty of evidence. Conclusions: Octreotide may represent a feasible therapeutic option for portal hypertension-related GI bleeding in children; however, further prospective and standardized studies are needed to establish its long-term safety and efficacy. Full article
(This article belongs to the Special Issue Pharmacovigilance in Drug Therapy and Adverse Reactions)
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