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Clinical Pharmacology: Adverse Drug Reactions
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Clinical Pharmacology: Adverse Drug Reactions

A special issue of Journal of Clinical Medicine (ISSN 2077-0383). This special issue belongs to the section "Pharmacology".

Deadline for manuscript submissions: 25 November 2025 | Viewed by 1050

Special Issue Editors

Dr. Andrej Belančić

E-Mail Website
Guest Editor
1. Department of Clinical Pharmacology, Clinical Hospital Centre Rijeka, Rijeka, Croatia
2. Department of Basic and Clinical Pharmacology with Toxicology, Faculty of Medicine, University of Rijeka, Rijeka, Croatia
Interests: clinical pharmacology; diabetes; evidence-based medicine; metabolic syndrome; obesity
Special Issues, Collections and Topics in MDPI journals
Dr. Ivana Mudnić

E-Mail Website
Guest Editor
Department of Pharmacology, University of Split School of Medicine, Šoltanska 2a, 21000 Split, Croatia
Interests: rational pharmacotherapy; cardiovascular pharmacology; lifestyle medicine

Special Issue Information

Dear Colleagues,

The Journal of Clinical Medicine (JCM) is pleased to announce the launch of this Special Issue, entitled “Clinical Pharmacology: Adverse Drug Reactions”. This Special Issue aims to explore the latest advancements in understanding, detecting, and preventing adverse drug reactions (ADRs), a critical challenge in pharmacology and patient safety.

The scope of this Special Issue includes, but is not limited to, pharmacovigilance, drug interactions, genetic predispositions, real-world evidence, and innovative strategies for ADR mitigation. We welcome studies utilizing clinical trials, observational studies, and advanced analytical methods to improve drug safety and therapeutic outcomes. Submissions focusing on the role of biomarkers in ADR prediction, personalized medicine approaches, and regulatory frameworks for drug safety monitoring are highly encouraged. Additionally, research on ADRs in special populations, such as pediatric, geriatric, and polypharmacy patients, is of particular interest.

Dr. Andrej Belančić
Dr. Ivana Mudnić
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 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. Journal of Clinical Medicine is an international peer-reviewed open access semimonthly 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

  • pharmacology
  • adverse drug reactions
  • drug interactions
  • pharmacovigilance
  • drug safety

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Published Papers (2 papers)

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Research

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11 pages, 204 KiB  
Article
Post-Marketing Safety of Spinal Muscular Atrophy Therapies: Analysis of Spontaneous Adverse Drug Reactions from EudraVigilance
by Andrej Belančić, Petar Mas, Lara Miletić, Barbara Kovačić Bytyqi and Dinko Vitezić
J. Clin. Med. 2025, 14(9), 3173; https://doi.org/10.3390/jcm14093173 - 3 May 2025
Viewed by 529
Abstract
Background/Objectives: Spinal muscular atrophy (SMA) treatment has evolved with the approval of nusinersen, onasemnogene abeparvovec, and risdiplam. This study aims to assess the post-marketing safety profile of these therapies through the spontaneous adverse drug reaction (ADR) reports available in EudraVigilance (EV). Methods [...] Read more.
Background/Objectives: Spinal muscular atrophy (SMA) treatment has evolved with the approval of nusinersen, onasemnogene abeparvovec, and risdiplam. This study aims to assess the post-marketing safety profile of these therapies through the spontaneous adverse drug reaction (ADR) reports available in EudraVigilance (EV). Methods: Data from EV were retrieved via adrreports.eu for the suspected ADRs associated with nusinersen, onasemnogene abeparvovec, and risdiplam from their approval in the European Economic Area (EEA) to 31 December 2024. The ADR reports were exported and analysed using descriptive statistics in Microsoft Excel. Reporting odds ratios (RORs) with 95% confidence intervals (CIs) were calculated for suspected ADRs, focusing on reactions with a lower limit of the 95% CI exceeding 1. Results: A total of 3196, 806, and 956 individual case safety reports (ICSRs) were identified for nusinersen, onasemnogene abeparvovec, and risdiplam, respectively. The most frequently reported ADRs with significantly increased RORs included post-lumbar puncture syndrome (nusinersen: 11%), pyrexia (onasemnogene abeparvovec: 23%), and pneumonia (risdiplam: 9%). While some ADRs were therapy-specific, others were consistent with SMA disease progression and complications. Onasemnogene abeparvovec showed a notable prevalence of hepatotoxicity, while risdiplam was associated with gastrointestinal and respiratory events. Conclusions: To conclude, the analysis reinforces the known safety profiles of these SMA treatments while highlighting potential areas for further investigation. ADRs related to SMA complications require careful differentiation from true drug-related effects. Future pharmacovigilance efforts should focus on long-term safety assessments and real-world evidence to optimize treatment strategies. Full article
(This article belongs to the Special Issue Clinical Pharmacology: Adverse Drug Reactions)

Review

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25 pages, 1139 KiB  
Review
Lamotrigine Therapy: Relation Between Treatment of Bipolar Affective Disorder and Incidence of Stevens–Johnson Syndrome—A Narrative Review of the Existing Literature
by Kacper Żełabowski, Kacper Wojtysiak, Zuzanna Ratka, Kamil Biedka and Agnieszka Chłopaś-Konowałek
J. Clin. Med. 2025, 14(12), 4103; https://doi.org/10.3390/jcm14124103 - 10 Jun 2025
Viewed by 355
Abstract
Lamotrigine is the drug of choice for the treatment of depressive episodes in bipolar disorder (BD). Despite its generally favorable tolerability profile, lamotrigine use is associated with a risk of Cutaneous Adverse Drug Reactions (cADRs), including Stevens–Johnson Syndrome (SJS) and Lyell’s syndrome, also [...] Read more.
Lamotrigine is the drug of choice for the treatment of depressive episodes in bipolar disorder (BD). Despite its generally favorable tolerability profile, lamotrigine use is associated with a risk of Cutaneous Adverse Drug Reactions (cADRs), including Stevens–Johnson Syndrome (SJS) and Lyell’s syndrome, also known as toxic epidermal necrolysis (TEN). Genetic markers HLA and, in particular, HLA-B 15:02 and HLA-A 31:01 are crucial in predicting individuals’ susceptibility to developing the symptoms. The symptoms are triggered by type IV hypersensitivity developing because of CTL and NK cell activation, leading to keratinocyte apoptosis, epidermal necrosis and skin detachment. The exact pharmacotherapy that should be widely utilized in treating affected patients has not yet been established. New therapies including JAK inhibitors or cyclosporine show potential in improving outcomes by reducing mortality and enhancing the period of recovery. Key factors in preventing cADRs may include adequate patient observation, gradual titration of the patient’s dose, and reduction of risk factors through screening for HLA polymorphisms. When the initial symptoms of cADR are identified, it is imperative to make an immediate decision to discontinue treatment, as this can significantly reduce the risk of progression to SJS/TEN and systemic complications. The purpose of this review is to identify a significant correlation between lamotrigine use in BD and the occurrence of SJS by showing the risk factors, neuropharmacological mechanisms, immune response and correctness of pharmacotherapy. Full article
(This article belongs to the Special Issue Clinical Pharmacology: Adverse Drug Reactions)
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