The occurrence of an adverse drug event (ADE) has become a serious social concern of public health. Early detection of ADEs can lower the risk of drug safety as well as the expense of the drug. While post-market spontaneous reports of ADEs remain a cornerstone of pharmacovigilance, most existing signal detection algorithms rely on substantial accumulated data, limiting their applicability to early ADE detection when reports are scarce. To address this issue, we propose a label propagation model for generating enhanced drug safety signals using multiple drug features. We first construct multiple drug similarity networks using a range of drug features. We then calculate initial drug safety signals using conventional signal detection algorithms. These original signals are subsequently propagated across each drug similarity network to obtain enhanced drug safety signals. We evaluate our proposed model using two common signal detection algorithms on data from the FDA Adverse Event Reporting System (FAERS). Results demonstrate that enhanced drug safety signals with pre-clinical information outperform the standard safety signal detection algorithms on early ADE detection. In addition, we systematically evaluate the performance of different drug similarities against different types of ADEs. Furthermore, we have developed a web interface (http://drug-drug-sim.aimedlab.net/) to display our multiple drug similarity scores, facilitating access to this valuable resource for drug safety monitoring.
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http://dx.doi.org/10.1016/j.heliyon.2024.e39728 | DOI Listing |
Cytotherapy
November 2024
Department of Translational and Precision Medicine, University of Rome, Rome, Italy. Electronic address:
Cellular and gene therapy (CGT) products have emerged as a popular approach in regenerative medicine, showing promise in treating various pancreatic and liver diseases in numerous clinical trials. Before these therapies can be tested in human clinical trials, it is essential to evaluate their safety and efficacy in relevant animal models. Such preclinical testing is often required to obtain regulatory approval for investigational new drugs.
View Article and Find Full Text PDFAm J Sports Med
January 2025
Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.
Background: Selective androgen receptor modulators (SARMs) are small-molecule compounds that exert agonist and antagonist effects on androgen receptors in a tissue-specific fashion. Because of their performance-enhancing implications, SARMs are increasingly abused by athletes. To date, SARMs have no Food and Drug Administration approved use, and recent case reports associate the use of SARMs with deleterious effects such as drug-induced liver injury, myocarditis, and tendon rupture.
View Article and Find Full Text PDFRheumatol Ther
January 2025
Biosplice Therapeutics, Inc., 9360 Towne Centre Dr, San Diego, CA, 92121, USA.
Introduction: Lorecivivint (LOR), a CDC-like kinase/dual-specificity tyrosine kinase (CLK/DYRK) inhibitor thought to modulate inflammatory and Wnt pathways, is being developed as a potential intra-articular knee osteoarthritis (OA) treatment. The objective of this trial was to evaluate long-term safety of LOR within an observational extension of two phase 2 trials.
Methods: This 60-month, observational extension study (NCT02951026) of a 12-month phase 2a trial (NCT02536833) and 6-month phase 2b trial (NCT03122860) was administratively closed after 36 months as data inferences became limited.
Acta Vet Scand
January 2025
Department of Veterinary and Animal Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Grønnegårdsvej 2, 1870, Frederiksberg C, Denmark.
Background: Prevention of iron deficiency in suckling piglets by intramuscular injection of a standardized amount of iron dextran or gleptoferron in the first days of life can lead to over- or underdosage with respective health risks. Currently, combined iron products containing an active substance against coccidia are also used on farms. When using a combination product targeting two diseases, an adjustment of the necessary amount of iron to prevent anaemia in the frame of a farm-specific treatment protocol is not possible.
View Article and Find Full Text PDFBMC Chem
January 2025
Energy Systems Engineering Department, Engineering Faculty, Adana Alparslan Türkeş Science and Technology University, 01250, Adana, Türkiye.
Although the antiallergic properties of compounds such as CAPE, Melatonin, Curcumin, and Vitamin C have been poorly discussed by experimental studies, the antiallergic properties of these famous molecules have never been discussed with calculations. The histamine-1 receptor (H1R) belongs to the family of rhodopsin-like G-protein-coupled receptors expressed in cells that mediate allergies and other pathophysiological diseases. In this study, pharmacological activities of FDA-approved second generation H1 antihistamines (Levocetirizine, desloratadine and fexofenadine) and molecules such as CAPE, Melatonin, Curcumin, Vitamin C, ADMET (Absorption, Distribution, Metabolism, Excretion, Toxicity) profiles, density functional theory (DFT), molecular docking, biological targets and activities were compared by calculating.
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