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Pharmaceuticals
Special Issues
Pediatric Drug Therapy: Safety, Efficacy, and Personalized Medicine
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Pediatric Drug Therapy: Safety, Efficacy, and Personalized Medicine

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 4872

Special Issue Editor

Prof. Dr. Catherine M. T. Sherwin

E-Mail Website1 Website2
Guest Editor
1. Department of Pediatrics and Department of Pharmacology & Toxicology, Wright State University Boonshoft School of Medicine, Dayton, OH, USA
2. Internal Medicine, UWA Medical School, The University of Western Australia, Perth, Australia
Interests: clinical pharmacology; clinical toxicology; pharmacometrics; pediatric pharmacology; maternal-fetal pharmacology; population pharmacokinetics; interventional trials; optimal trial design

Special Issue Information

Dear Colleagues,

Pediatric pharmacotherapy has unique problems owing to children's specific physiological features and developmental stages, which can markedly affect drug metabolism, effectiveness, and safety. Historically, several drugs have been administered to children without thorough pediatric-specific research, resulting in possible dangers and inadequate therapeutic results. Recent breakthroughs in pharmacogenomics and model-informed precision dosing have facilitated personalized medicine approaches in kids, seeking to customize therapies according to individual genetic profiles and unique requirements. This Special Issue investigates recent research and advancements in pediatric pharmacotherapy, emphasizing safety evaluations, effectiveness assessments, and customized medicine approaches. We solicit submissions that explore subjects including pharmacokinetic and pharmacodynamic research in pediatric populations, the influence of pharmacogenomics on drug response prediction, novel clinical trial methodologies for children, and case studies illustrating the effective application of personalized therapies in pediatric healthcare. By aggregating these findings, we want to improve the comprehension and implementation of safe and effective pharmacological treatments specifically designed for the pediatric demographic.

Prof. Dr. Catherine M. T. Sherwin
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 100 words) can be sent to the Editorial Office for announcement on this website.

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

  • pediatric pharmacotherapy
  • drug safety in children
  • pediatric drug efficacy
  • personalized medicine in pediatrics
  • pediatric pharmacokinetics
  • pediatric pharmacodynamics
  • pharmacogenomics in children
  • pediatric clinical trials
  • pediatric dosing strategies
  • pediatric drug formulations

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Published Papers (4 papers)

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10 pages, 215 KiB  
Article
Spontaneous Adverse Drug Reaction Reporting of Congenital Malformations: A Danish National Register Study
by Ulrik Lausten-Thomsen, Rasmus Huan Olsen, Michael Christiansen, Paula L. Hedley, Ida Marie Heerfordt, Jon Trærup Andersen and Christina Gade
Pharmaceuticals 2025, 18(6), 917; https://doi.org/10.3390/ph18060917 - 18 Jun 2025
Viewed by 402
Abstract
Background/Objectives: Maternal use of medication during pregnancy may have teratogenic effects, as seen with drugs like thalidomide, valproate, and phenytoin. Despite rigorous testing, both new and established drugs still pose a risk of teratogenesis, particularly if the teratogenic effects are probabilistic and [...] Read more.
Background/Objectives: Maternal use of medication during pregnancy may have teratogenic effects, as seen with drugs like thalidomide, valproate, and phenytoin. Despite rigorous testing, both new and established drugs still pose a risk of teratogenesis, particularly if the teratogenic effects are probabilistic and not deterministic. Public health organizations maintain registers to centralize and evaluate adverse drug reactions (ADR). However, underreporting in these registries can obscure the signals of drug-related congenital malformations. This study aims to evaluate potential ADR-associated congenital malformations in Denmark over the past decade; Methods: An observational cross-sectional study was conducted using data from the national Danish Medicines Agency’s pharmacovigilance database, which includes all spontaneous ADR reports submitted to the Danish Medicines Agency from 1 July 2013 to 30 June 2023. Maternal antenatal drug use was identified, and reported ADRs were assessed for congenital malformations; Results: We identified reports of potential ADR-related congenital malformations in 75 children, with 92 diagnoses as classified by ICD-10. Eighty-five different drugs from 58 ATC codes were implicated. Only three diagnoses were reported in five or more children. The reports were generally sporadic, with no new signals detected; Conclusions: Public awareness is crucial when novel threats arise from medications, infections, or technologies, as these may pose risks to unborn children. Ongoing monitoring of potential ADR-related congenital malformations remains a critical component of public health. Given the potential underreporting, we encourage a low threshold for reporting ADRs based on suspicion alone, with final causality assessments made by health authorities. Full article
(This article belongs to the Special Issue Pediatric Drug Therapy: Safety, Efficacy, and Personalized Medicine)
17 pages, 1981 KiB  
Article
Real-World Safety Profile of Proton Pump Inhibitors in Infants as Reported in the FDA Adverse Event Reporting System (FAERS): Tiny Tummies, Key Decisions
by Hülya Tezel Yalçın, Nadir Yalçın and Karel Allegaert
Pharmaceuticals 2025, 18(5), 730; https://doi.org/10.3390/ph18050730 - 16 May 2025
Viewed by 1226
Abstract
Background: Proton pump inhibitors (PPIs) are widely used for gastric acid suppression, yet their efficacy and safety in neonates and infants remain unclear. While esomeprazole is the only Food and Drug Administration (FDA)-approved PPI for neonates and infants under 1 year of [...] Read more.
Background: Proton pump inhibitors (PPIs) are widely used for gastric acid suppression, yet their efficacy and safety in neonates and infants remain unclear. While esomeprazole is the only Food and Drug Administration (FDA)-approved PPI for neonates and infants under 1 year of age, other PPIs are also frequently prescribed. Objectives: This study utilizes FDA Adverse Event Reporting System (FAERS) data to evaluate potential adverse drug events (ADEs) of PPIs, providing crucial real-world insights into their safety in this vulnerable population. Methods: This observational cross-sectional study was conducted using an individual case safety report (ICSR) database. Only reports in neonates or infants receiving omeprazole, pantoprazole, lansoprazole, rabeprazole, or esomeprazole monotherapy were evaluated. The most frequently prescribed PPI, the most common indication, the most reported ADE, the seriousness of AEs, and the countries reporting the highest ADE number were analyzed using 2D disproportionality analyses (e.g., reporting odds ratio (RORs)). Results: A total of 464 patients were included; 323 (69.6%) of them were stated as serious and 15 (3.2%) of them were stated as time-related to mortality. Most of the ADEs were reported for lansoprazole (45.9%). The most reported PPI-associated ADE was vomiting (8.8%). According to the RORs analysis, vomiting associated with PPI monotherapy was more likely to occur (RORs: 2.88, 95% CI: 2.09–3.96), which is followed by diarrhea, hypertrichosis, choking, and erythema. Additionally, medication errors were reported in 50 (10.8%) patients. Conclusions: ICSR databases are valuable pharmacovigilance tools. The absence of access to a causality assessment is a limitation since it limits its ability to confirm whether the ADEs are truly caused by the suspected drug, mitigated using RORs analysis. Integrating neonatal-specific algorithms could enhance drug safety evaluations, strengthen evidence-based decision-making, and improve risk–benefit assessments in neonates and infants. Full article
(This article belongs to the Special Issue Pediatric Drug Therapy: Safety, Efficacy, and Personalized Medicine)
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16 pages, 634 KiB  
Systematic Review
Lurasidone for Pediatric Bipolar Disorder: A Systematic Review
by Alexia Koukopoulos, Claudia Calderoni, Georgios D. Kotzalidis, Tommaso Callovini, Lorenzo Moccia, Silvia Montanari, Gianna Autullo, Alessio Simonetti, Mario Pinto, Giovanni Camardese, Gabriele Sani and Delfina Janiri
Pharmaceuticals 2025, 18(7), 979; https://doi.org/10.3390/ph18070979 - 30 Jun 2025
Viewed by 537
Abstract
Background/Objectives: Lurasidone ((3aR,4S,7R,7aS)-2-{(1R,2R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl]cyclohexylmethyl}hexahydro-4,7-methano-2H-isoindole-1,3-dione) is a second-generation antipsychotic approved for schizophrenia and mood disorders. Adolescents and children with bipolar disorder receive treatments that expose them to weight gain and metabolic syndrome. Lurasidone is relatively free from such side effects, so it may constitute [...] Read more.
Background/Objectives: Lurasidone ((3aR,4S,7R,7aS)-2-{(1R,2R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl]cyclohexylmethyl}hexahydro-4,7-methano-2H-isoindole-1,3-dione) is a second-generation antipsychotic approved for schizophrenia and mood disorders. Adolescents and children with bipolar disorder receive treatments that expose them to weight gain and metabolic syndrome. Lurasidone is relatively free from such side effects, so it may constitute a useful alternative for the treatment of these patients. We focused on the use of lurasidone in children and adolescents with bipolar disorder. Methods: On 11 June 2025, we used the following strategy on PubMed: lurasidone AND (“bipolar disorder” OR “bipolar depression” OR mania OR manic). We filtered for humans and ages 0–18 years and included case reports and clinical studies. Similar strategies adapted to each database were used to carry out our systematic review on CINAHL, PsycINFO/PsycARTICLES, Scopus, and the ClinicalTrials.gov register on the same date. We excluded reports without children/adolescent participants, those grouping adult participants with children/adolescents without providing data separately, reviews, and opinions/editorials with no data. Eligibility was determined through Delphi rounds; it was required that consensus was reached among all authors. We followed the PRISMA-2020 Statement. Results: Our search produced 38 results on PubMed on 11 June 2025. We included four case reports/series and five studies. One additional eligible study emerged from our Scopus inquiry, raising the number of eligible studies to six. One case series was moderately positive; one case report was neutral, another was positive, and one reported the induction of mania. The six longitudinal studies involved 16,735 participants and showed generally good efficacy. Conclusions: The use of lurasidone in adolescents/children with bipolar disorder obtains favorable results regarding the excitatory and depressive symptoms of bipolar disorder with no significant side effects. Full article
(This article belongs to the Special Issue Pediatric Drug Therapy: Safety, Efficacy, and Personalized Medicine)
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19 pages, 483 KiB  
Systematic Review
Omalizumab and Oral Immunotherapy in IgE-Mediated Food Allergy in Children: A Systematic Review and a Meta-Analysis
by Enrico Vito Buono, Giuliana Giannì, Sara Scavone, Susanna Esposito and Carlo Caffarelli
Pharmaceuticals 2025, 18(3), 437; https://doi.org/10.3390/ph18030437 - 20 Mar 2025
Cited by 2 | Viewed by 2153
Abstract
Background: Food allergies are a growing global health concern, particularly among children, with no widely approved curative treatment beyond strict allergen avoidance. Oral immunotherapy (OIT) has emerged as a promising strategy to induce desensitization, yet its implementation is limited due to high rates [...] Read more.
Background: Food allergies are a growing global health concern, particularly among children, with no widely approved curative treatment beyond strict allergen avoidance. Oral immunotherapy (OIT) has emerged as a promising strategy to induce desensitization, yet its implementation is limited due to high rates of allergic reactions and patient non-compliance. Omalizumab, a monoclonal anti-IgE antibody, has been proposed as an adjunct to OIT to enhance safety and efficacy. Objective: This systematic review and meta-analysis aim to evaluate the efficacy and safety of omalizumab in combination with OIT for IgE-mediated food allergy in children. Methods: A systematic literature search was conducted in PubMed/MEDLINE and Cochrane Central databases to identify randomized controlled trials (RCTs), controlled clinical trials (CCTs), and observational studies assessing omalizumab as an adjunct to OIT in pediatric food allergy. Studies were evaluated for desensitization rates, immunological changes, adverse events, and quality-of-life improvements. Results: OIT combined with omalizumab led to significantly higher rates of desensitization, allowing patients to tolerate higher doses of allergens in a shorter timeframe compared to OIT alone. Omalizumab was associated with a reduction in adverse reactions, including anaphylaxis, and improved treatment adherence. However, the long-term sustainability of tolerance post-omalizumab discontinuation remains uncertain. Conclusions: Omalizumab facilitates rapid and effective desensitization in pediatric food allergy, enhancing the safety of OIT. Further research is needed to determine optimal treatment duration, long-term outcomes, and cost-effectiveness before widespread clinical adoption. Full article
(This article belongs to the Special Issue Pediatric Drug Therapy: Safety, Efficacy, and Personalized Medicine)
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