Adverse drug reactions (ADRs) are an important and potentially preventable cause of morbidity among hospitalized obstetric patients, with implications for both maternal and fetal safety, yet evidence from low-resource settings remains limited. This prospective observational study, conducted from February to May 2025 at Debre Tabor Comprehensive Specialized Hospital, Ethiopia, aimed to determine the magnitude, characteristics, preventability, and determinants of ADRs among hospitalized pregnant women and postpartum women within six weeks of delivery. ADRs were identified through daily chart review and patient interviews and confirmed using the Naranjo Adverse Drug Reaction Probability Scale, while severity and preventability were assessed using the modified Hartwig and Siegel scale and the Schumock and Thornton criteria, respectively. Multivariate logistic regression was used to identify factors independently associated with ADR occurrence. Among the 354 patients included, 52 experienced at least one ADR, yielding a prevalence of 14.7%. Most ADRs were mild to severe (88.5%) and classified as definitely preventable (82.7%). Polypharmacy (4-6 medications) was independently associated with ADR occurrence (adjusted odds ratio [AOR] = 4.02; 95% CI: 1.63-9.93). Additionally, patients with a history of adverse pregnancy outcomes (AOR = 6.28; 95% CI: 2.64-14.95) and those with underlying medical comorbidities (AOR = 2.95; 95% CI: 2.23-9.76) had significantly higher odds of experiencing ADRs. ADRs were relatively common among hospitalized obstetric patients, and the predominance of preventable events highlights the need for strengthened pharmacovigilance systems and targeted medication safety interventions to reduce preventable harm and improve maternal and fetal outcomes in resource-limited settings.

Adverse drug reactions (ADRs) are a major cause of morbidity, hospital admissions, and in-hospital mortality, yet remain incompletely captured by post-marketing pharmacovigilance, which suffers from underreporting. Electronic health records (EHRs) contain clinical narratives that can reveal otherwise unreported ADRs. Natural language processing (NLP) offers a scalable means to extract structured information from clinical narratives, supporting ADR detection and assessment. We conducted a retrospective cross-sectional study within a multisite hospital network in Southern Switzerland to develop and evaluate NLP systems for ADR detection and information extraction from electronic discharge summaries. ADR classification models were trained on 400 discharge summaries and compared across multiple machine learning and vectorization strategies against a regular expression (regex) system. Drug and clinical event extraction were evaluated using 100 manually annotated summaries, benchmarking a dictionary-based approach against a two-step deep learning (DL) pipeline integrating transformer-based named entity recognition (NER) with a pharmacovigilance-oriented contextual relevance classifier. Performance was evaluated using standard metrics and a custom top-k ranking metric aligned with pharmacovigilance experts' daily capacity for reviewing positive cases to confirm the presence of ADRs. Logistic regression with Bag-of-Words achieved the best overall performance, combining high precision and effective case ranking. In a simulated deployment, this model identified nearly twice as many discharge summaries containing confirmed ADRs than as regex system. The two-step DL pipeline outperformed the dictionary-based approach for drug and clinical event recognition and accurately classified them according to pharmacovigilance purposes. These results demonstrate that NLP-based analysis of real-world clinical narratives can enhance pharmacovigilance while maintaining a manageable expert workload.

Factors influencing identification capability of adverse drug reactions in children aged 8-18years based on social cognitive theory.

Insomnia is a common symptom in depressive disorder, affecting up to 80% of those patients. Evidences suggest that sleep symptom improvements could alleviating depressive symptoms and reducing relapse. This article evaluated the efficacy of three antidepressants-agomelatine, mirtazapine, and trazodone-in treating insomnia symptoms in depressed patients, with a focus on polysomnographic (PSG) data, subjective sleep experience, improvement in depressive symptoms, and adverse drug reactions. A systematic search of PubMed, Cochrane Library, MEDLINE, Embase, and Web of Science was conducted for studies published from 1974 to August 2025; 30 studies (16 randomized controlled trials and 14 non-randomized controlled trials) were included. The primary outcomes were PSG measures; secondary outcomes included PSQI and HAMD scores, as well as adverse medication reactions. The PSG results showed that agomelatine may not significantly change percentage N1 of sleep period time (N1%) and Latency of REM sleep (L-REM). Mirtazapine significantly increased total sleep time (TST), slow-wave sleep of sleep period time (SWS%), and sleep efficiency (SE%), while reducing percentage wake after sleep onset of sleep period time (WASO%). Trazodone notably improved TST, and SE%. For adverse effects, agomelatine was well-tolerated; mirtazapine commonly caused weight gain and sedation; and trazodone frequently led to dizziness, sedation, headache, nausea, and somnolence. All three medications significantly enhance subjective sleep perception and alleviate depressive symptoms. However, agomelatine may lack a definitive effect on improving objective sleep parameters in depressed patients. Future studies should involve larger, high-quality trials with unified methodologies to strengthen the reliability of conclusions.

Safety evaluation of an effervescent curcuminoids-ascorbic acid-polysaccharide-β-cyclodextrin (CUR-A-Poly-β-CD) inclusion complex powder in healthy volunteers: A non-placebo-controlled pilot study.

A Real-World Pharmacovigilance Study of Cilostazol Based on the Food and Drug Administration Adverse Event Reporting System: A Cross-Sectional Disproportionality Analysis.

National data on clinical pharmacy implementation can inform health policy, resource allocation, workforce planning, and academic development. In Chile, such data are limited, particularly for therapeutic drug monitoring (TDM). The objective of this study was to characterize the clinical pharmacy workforce in Chilean hospitals and describe the implementation of core clinical activities, with an emphasis on TDM. A national cross-sectional survey was conducted among pharmacists performing clinical functions in Chilean hospitals, using the 2024 registry of the Clinical Pharmacy Division of the Chilean Society of Intensive Care Medicine as the sampling frame. Descriptive analyses were performed; workforce capacity was expressed as full-time equivalents (FTEs) and regional density per 10 000 inhabitants. Of 220 invited pharmacists, 181 responded (82.3%), representing 83 institutions across 15 of 16 administrative regions. Median age was 35 years (interquartile range [IQR] 31-39); 28.2% were registered Clinical Pharmacy Specialists, and 77.1% worked in public hospitals. The highest density was in the Metropolitan Region (0.12 FTE/10000 inhabitants), followed by Tarapacá and Antofagasta (0.09 each). Deployment was most frequent in Infectious Diseases (36.5%) and intensive care units (34.8%). Pharmacotherapy follow-up and medication therapy review were each reported by 94.5%, adverse drug reaction reporting by 87.3%, and involvement in TDM by 85.1%. Teaching and research were reported by 44.8% and 30.4%, respectively, but 95.5% reported no formally protected time. TDM was available in 81.9% of centers, most commonly for vancomycin (80.7%), valproic acid (63.9%), amikacin (60.2%), and phenytoin (57.8%); pharmacokinetic software to support dose individualization was used in 61.4% of centers. Clinical pharmacy services in Chile are broadly integrated into hospital care-particularly in infectious diseases, critical care, and TDM-while gaps persist in formal credentialing, regional workforce distribution, and institutional structures supporting academic activities.

Identifying and discontinuing the offending drug(s) in severe cutaneous adverse drug reactions (SCARs) can be particularly challenging, especially in polymedicated patients. For many years, patch tests (PTs) were considered the only safe and reliable method for investigating SCARs. However, intradermal tests (IDTs), once thought to be contraindicated, have recently garnered increasing interest. Similarly, oral provocation tests, previously avoided due to safety concerns, are now being more frequently employed in SCAR assessment. We analysed SCARs reported at Monastir University Hospital. Allergy work-up included PTs, IDTs and oral provocation tests, with evaluation of cross-reactivity, co-sensitisation and neo-sensitization. We identified 190 SCAR episodes in 188 patients. DRESS was most frequent (75%), followed by AGEP (19%) and SJS/TEN (6%). Causative drugs were identified in 97.9% of cases, mainly anti-infectives. Skin tests were conducted in 69.5% of patients, yielding positivity rates of 49% for PTs and 77% for IDTs in DRESS, and 52% and 66%, respectively, in AGEP. Cross-reactivity was noted in 7% of DRESS and 11.1% of AGEP, while neo-sensitization was documented in 32.5% of DRESS patients. Allergological investigations are valuable tools in SCAR management, enabling identification of culprit drugs, assessment of cross-reactivity, detection of neo-sensitization and selecting safe alternatives.

This post-marketing surveillance study assessed the safety and effectiveness of guanfacine hydrochloride extended-release (GXR) in adults with attention-deficit/hyperactivity disorder (ADHD) in routine clinical practice in Japan. In this prospective, multicenter study, adults (≥ 18years) were followed for 1year after initiating GXR treatment or until treatment discontinuation, whichever occurred first (enrollment: June 2020-March 2022). Hypotension and bradycardia, syncope, blood pressure elevation upon discontinuation, and QT prolongation were key safety concerns for evaluation. Missing data were not imputed; therefore, effectiveness outcomes reflect only the observed data. In total, 961 patients were enrolled across 155 sites; case report forms were collected for 949 patients. Of these, 912 and 784 were included in the safety and effectiveness analyses, respectively. The 12-month GXR continuation rate was 45.2%. Adverse drug reactions (ADRs) reported in ≥ 1% of patients were somnolence (15.02%), dizziness (3.95%), malaise (3.73%), postural dizziness (2.85%), thirst (2.52%), decreased blood pressure (1.86%), hypotension (1.54%), and constipation (1.43%). Seventeen serious ADRs occurred in 13 patients: bradycardia, cerebral ischemia, mental impairment, and syncope (n = 2 each) and decreased blood pressure, delusions, dizziness, postural dizziness, erectile dysfunction, hallucination, psychomotor hyperactivity, somnolence, and suicidal ideation (n = 1 each). Forty-one patients (4.50%) experienced 42 hypotension and bradycardia events (3 were serious). Two patients (0.22%) experienced a syncope event (preferred term: syncope); although both were assessed as non-serious by the investigator, they were classified as serious per the Important Medical Events list. In accordance with the Japanese Risk Management Plan, these two events were also recorded as QT prolongation events (preferred term: syncope). Improvement rates in Clinical Global Impression-Improvement and Patient Global Impression-Improvement scales increased over the 1-year observation period. ADHD-Rating Scale-IV total and subscale scores also improved over time, with significant improvements from baseline observed at all time points (p < 0.0001). No ADRs requiring new safety measures were observed. The effectiveness of GXR in adult ADHD was evident among patients remaining on treatment. UMIN Clinical Trials Registry (identifier: UMIN000040429).

Pharmacovigilance (PV) plays a critical role in monitoring and evaluating adverse drug reactions (ADRs) to ensure the safety of marketed medical products. This study aimed to assess the quality of ADR reports submitted to the national PV center of Nepal by comparing pre- and post-training periods, and to identify factors associated with ADR reporting quality. A retrospective analysis of ADR reports submitted to the national PV center was conducted over a three year period. Reports from January 2020 to November 2022 were classified as the pre-training phase while reports from December 2022 to April 2023 consitituted the post-training phase. In December 2022, the research team developed and implemented a capacity building plan that included a two-day training program for regional PV center contact persons, consisting of pharmacists and other health care professionals (HCPs) responsible for submitting ADR reorts through the VigiFlow system. The quality of ADR reports was assessed using the validated Adverse Drug Report Quality Algorithm (AQUA-12) tool. Statistical analysis was performed using Microsoft Excel and R. A total of 86 reports were evaluated, 57 from the pre-training phase and 29 from the post-training phase. Overall, 35% (n = 30) of the reports were classified as high quality according to the AQUA-12 criteria. Prior to the training, only 16% (n = 9) met the high quality level whereas this proportion increased to 72% (n = 21) following the training. This improvement in ADR reporting quality was statistically significant (p = 0.000; p < 0.05). The training significantly improved the quality of ADR reports, underscoring the value of continuous quality improvement within PV systems. Targeted programs for health care professionals, particularly pharmacists and regulatory authority personnel, are essential to strengthen ADR reporting quality and enhancing patient safety.

An adverse drug reaction (ADR) is a harmful, unwanted patient response to a drug that happens at doses normally used for prevention, diagnosis, or treatment. Despite limited and inconsistent primary evidence on the cost of ADRs in Africa, this systematic review aims to synthesize the magnitude of ADR-related costs and assess the reporting quality of existing studies. The authors followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist. Three databases (PubMed, Scopus, and ScienceDirect) and a hand search were employed. All empirical African cost-of-illness studies on ADRs were included regardless of publication year, disease type, or population, while letters to the editor, case reports, conference proceedings, and abstracts were excluded. Two independent authors conducted screening, data extraction, and quality assessment. A consensus-based cost-of-illness checklist was used to assess reporting quality. The primary outcome was the cost of adverse drug reactions, reported in 2024 international dollars (I$); the secondary outcome was the reporting quality of studies. A total of 324 studies were identified, of which eight were included in the final analysis. Nearly all studies reported only direct medical costs, excluding direct non-medical and indirect costs. ADR-related hospitalization costs per patient ranged from I$54.75 in Nigeria to I$7438.47 in South Africa. Costs were mainly driven by hospitalization, medications, and investigations, and influenced by patient, disease, and health system-related factors. While all studies described their population, objectives, time horizon, and data collection methods, many failed to report important methodological details. Adverse drug reactions impose a substantial economic burden through direct medical costs influenced by multiple factors; however, many studies lacked key reported details. Future research should adopt recommended methodologies and comprehensive cost reporting to improve the reliability of cost estimates.

In South Korea, belimumab is indicated for patients with systemic lupus erythematosus (SLE), including paediatric patients aged ≥ 5 years, and for adults with lupus nephritis, based on clinical trial evidence; however, real-world data in this population remain limited. To assess the real-world safety and effectiveness of intravenous (IV) belimumab administered in patients with SLE in South Korea. This observational study (GSK Study 216984) enrolled patients with active SLE and patients with lupus nephritis across 18 South Korean institutions (July 2021-February 2023). Patients received on-label IV belimumab plus standard therapy (antimalarials, glucocorticoids and immunosuppressants). Data were collected for a minimum of 48 weeks as part of routine clinical practice (July 2021-March 2024). Safety was assessed by monitoring the incidence of adverse events (AEs), adverse drug reactions (ADRs), serious AEs (SAEs)/ADRs and AEs of special interest (including psychiatric events) and summarised descriptively. Changes in SELENA-SLEDAI scores, laboratory biomarkers and glucocorticoid dosage from baseline to week 24 or 48 were tested using the Wilcoxonsigned-rank test. Of 126 enrolled patients, 105 were eligible for the ≥ 48-week safety evaluation (completed ≥ 24 weeks of belimumab treatment). Patients were mostly female (91.4%, n = 96/105), with mean (SD) SLE duration of 9.9 (8.1) years; 45.7% (n = 48/105) of patients had lupus nephritis. AEs and SAEs were experienced by 66.7% (n = 70/105) and 18.1% (n = 19/105) of patients; most events were mild or moderate in severity and unlikelyto be related to belimumab. ADRs were reported for 3.8% (n = 4/105) of patients, and psychiatric events for 2.9% (n = 3/105). SELENA-SLEDAI and laboratory biomarkers significantly improved, and glucocorticoid dosage significantly reduced, between baseline and weeks 24 and 48. This real-world study identified no new safety concerns and demonstrated effectiveness of belimumab, supporting its use in Korean patients.

ALZ-101 is a therapeutic vaccine comprised of a stabilised oligomeric derivative of amyloid-β42 (Aβ42), denoted Aβ42CC, that elicits antibodies targeting a low-abundance, neurotoxic Aβ oligomer species. This first-in-human, single-center Phase 1b trial evaluated the safety, tolerability, and immunogenicity of ALZ-101, with exploratory biomarker and clinical outcomes, in participants with early Alzheimer's disease (AD). Thirty‑two participants with biomarker‑confirmed early AD (mean age ∼69 years, ∼30% female, Mini‑Mental State Examination ∼24, Alzheimer's Disease Composite Score [ADCOMS] ∼0.55, Clinical Dementia Rating-Sum of Boxes ∼3.0, ∼70% APOE ε4 carriers) were enrolled in a randomised, double‑blind, placebo‑controlled main study (Part A1) and a semi‑blinded extension (Part B). In Part A1, participants received intramuscular ALZ‑101 125µg (n = 10) or 250µg (n = 10) or placebo (n = 6) at Weeks 0, 4, 8, and 16. After ≥ 14 weeks of follow‑up, eligible participants (n = 23) entered Part B and received two or four additional 250µg doses of ALZ‑101 with partial blinding of original allocation. An open‑label arm (Part A2) explored ALZ‑101 400µg (n = 6) on the same schedule as Part A1. Primary endpoints were safety and tolerability. Secondary and exploratory endpoints included Aβ‑specific antibody responses, cerebrospinal fluid (CSF) and plasma biomarkers, and cognitive/functional scales. ALZ-101 was not associated with any clear safety signals, and no serious adverse drug reactions were observed. Sixteen asymptomatic ARIA‑H events, including two superficial siderosis events, occurred in nine participants (two initially on placebo, six on 125µg, one on 250µg), and one asymptomatic ARIA‑E occurred in the extension phase in a participant originally randomised to placebo; no ARIA was observed in the 400µg arm. ALZ‑101 induced robust Aβ‑specific IgG responses in nearly all vaccinated participants, with classical primary/booster kinetics and high responder rates at all dose levels. No statistically significant between‑group differences were detected for pre‑specified CSF biomarkers or cognitive and functional outcomes versus placebo in the randomised phase. Over longer follow‑up in Part B, participants initially randomised to ALZ‑101 showed numerically smaller increases in CSF neurofilament light (NfL) and tau and a flatter ADCOMS trajectory than those initially on placebo, but these differences were not statistically significant. For CSF tau, attenuation of the increase seemed to be present already in Part A1, whereas for the more slowly changing NfL, potential attenuation emerged only over the longer Part B. In this small Phase 1 study in early AD, ALZ‑101 was not associated with clear safety signals and elicited strong, durable Aβ‑specific antibody responses. Exploratory biomarker and ADCOMS findings are compatible with a possible disease‑modifying effect, but formal evidence of clinical efficacy is lacking, and all non‑primary analyses should be interpreted with caution. These results support further evaluation of ALZ‑101 in larger, adequately powered trials. Registered at clinicaltrials.gov: NCT05328115, 14 April 2022.

To evaluate the long-term safety outcomes of recombinant human growth hormone (rhGH) administered to Korean pediatric patients with growth disorders, including growth hormone deficiency, Turner syndrome, idiopathic short stature, small for gestational age, chronic kidney disease, and Prader-Willi syndrome, using 10-year interim data from the nationwide LG Growth Study registry in the Republic of Korea. Prospective, multicenter, observational registry. This interim analysis included 5,040 patients from 96 centers, representing 19,878 patient-years of treatment between November 2011 and December 2022. Although the registry spans 10 years, follow-up was limited to periods of active GH treatment and therefore varied across patients. Patients received daily or weekly rhGH. Adverse events (AEs), adverse drug reactions (ADRs), serious AEs (SAEs), and serious ADRs (SADRs) were recorded and compared with international registry data. Overall, AEs occurred in 34.2% of patients, ADRs in 7.0%, SAEs in 3.2%, and SADRs in 0.3%. The most frequent AE was scoliosis (1.6%), followed by headache (0.8%) and injection site pain (0.5%). Three malignant neoplasms were reported, yielding a standardized incidence ratio of 1.1 (95% confidence interval, 0.21-2.69), comparable to expected national rates. Craniopharyngioma recurrence occurred in 14.3% of affected patients, consistent with international data. Over 10 years, rhGH therapy in Korean pediatric patients demonstrated a low incidence of ADRs and SADRs, with malignancy and tumor recurrence rates similar to those in global registries. These findings support the long-term safety of rhGH for pediatric growth disorders, with continued surveillance warranted. Using 10 years of real-world data from a pediatric registry, conducted in the Republic of Korea, this study provides one of the largest single-nation safety evaluations of rhGH therapy across multiple etiologies of short stature. The low incidence rates of ADRs and SADRs, in alignment with rates reported for other large-scale international registries, provide reassuring evidence of the safety of rhGH for clinicians and caregivers.

Coproporphyrin I (CPI) is an established endogenous biomarker for detecting drug-drug interactions (DDIs) involving the hepatic uptake transporter Organic Anion Transporting Polypeptide 1B1 (OATP1B1, gene SLCO1B1). While CPI has been extensively studied in healthy volunteers using controlled pre- and post-OATP1B1-inhibitor sampling, its applicability in samples obtained in clinical routine from multimorbid, polymedicated patients remains poorly characterized. In this study, we evaluated whether single timepoint CPI concentrations obtained in clinical routine can be used to assess in vivo OATP1B1 activity by integrating genetic and pharmacological information. Serum CP levels were measured in patients undergoing pharmacist-led medication reviews following therapy failure or adverse drug reactions. CPI concentrations were analyzed in relation to genotype-predicted OATP1B1 phenotypes and exposure to drugs with potential impact on OATP1B1, which were identified following a previously published work by Stäuble et al., and their interaction with OATP1B1 was further evaluated with the herein presented in vitro transporter assay. CPI levels showed an association with drug intake and genotype-predicted phenotypes. Moreover, patients with decreased- or normal function phenotypes taking putative OATP1B1 inhibitors exhibited CPI levels comparable to patients carrying the poor-function or decreased-function phenotype without intake of such drugs, respectively, consistent with phenoconversion. These findings provide initial evidence that CPI may serve as an endogenous biomarker for identifying drug-drug-gene interactions in clinical routine to support a safer and more effective drug therapy. Furthermore, our data emphasize the need for further investigations in larger and more diverse patient populations to validate the findings on CPI.

ABSTRACT Background Polypharmacy is a growing concern in the management of patients with Type 2 diabetes mellitus (T2DM), as multiple comorbidities necessitate complex pharmacological regimens. However, excessive medication use has been associated with adverse drug reactions, medication non-adherence, and poor clinical outcomes. Understanding the impact of polypharmacy in patients with T2DM is essential for optimizing treatment strategies. Methods This nationwide, cross-sectional study analyzed data from a 2023 survey involving 4,956 patients with T2DM across Türkiye. Polypharmacy was defined as the use of five or more medications. Demographic characteristics, comorbidities, diabetes-related complications, and laboratory parameters were compared between patients using 1–4 medications and those with polypharmacy. Logistic regression analysis identified independent predictors of polypharmacy. Results Polypharmacy was observed in 46.7% (n = 2,312) of the patients. Those with polypharmacy were significantly older, had a longer diabetes duration, higher body mass index, and elevated systolic blood pressure (p < 0.001). The prevalence of macrovascular and microvascular complications was higher in this group (p < 0.001), and severe hypoglycemia was more frequent (p = 0.034). Regression analysis identified older age, longer diabetes duration, dyslipidemia, hypertension, nonalcoholic fatty liver disease, hypothyroidism, osteoporosis, coronary artery disease, cerebrovascular disease, neuropathy, and nephropathy as factors independently associated with polypharmacy (p < 0.001). Conclusion Polypharmacy is highly prevalent in older adults with T2DM and is associated with an increased burden of complications. These findings highlight the importance of careful medication assessment in patients with T2DM with complex comorbidity profiles. Clinical trial registration www.clinicaltrials.gov identifier is NCT06347445.

This systematic review and meta-analysis are aimed at evaluating the incidence of adverse drug reactions (ADRs) following administration of clinically approved ultrasound contrast agents (UCAs) in adults and children, to assess risks in patients with cardiovascular disease and in pregnancy, and to evaluate the effectiveness of emergency management of severe ADRs. A PRISMA 2020 systematic review was conducted searching PubMed, Scopus, and Embase. Two reviewers independently screened, extracted data, and assessed quality. Incidence estimates were pooled when feasible, stratified by age group, contrast agent, and administration route. Seventy-four studies encompassing > 1 million adults and > 36,000 children were included, contributing multiple analytic cohorts to the quantitative synthesis. Severe acute ADRs were extremely rare (6 and 16 cases per 100,000 in adults and children, respectively) and absent following endocavitary administration in children. Non-severe acute ADRs occurred in 11 and 8 cases per 10,000 adults and children, respectively. Delayed reactions were very rare (< 1 case per million in adults). No significant safety differences emerged between UCA products. The incidence of ADRs in patients with cardiovascular disease was analogous to the general population. No ADRs were reported in pregnant women. Standard emergency management was effective in almost all serious cases, though rare fatalities occurred. UCAs show an excellent safety profile in adults and children, with very rare severe ADRs and few non-severe, typically self-limiting reactions. Strict adherence to recommended emergency management protocols mitigates the remaining risks, supporting safe use across a broad range of clinical indications. CRD42023432668. Question What is the incidence, type, and severity of acute and delayed ADRs associated with clinically approved UCAs across different patient populations? Findings Severe acute adverse reactions are very rare, and non-severe reactions are rare and self-limiting, with no significant safety differences between adults, children, or patients with cardiovascular disease. Clinical relevant UCAs show an excellent safety profile across populations. These findings support their safe clinical use as reliable alternatives to iodine-based and gadolinium-based contrast agents in routine diagnostic imaging.

Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, is widely prescribed for type 2 diabetes mellitus and chronic weight management. With its growing global use, continuous pharmacovigilance is essential to detect emerging patterns of adverse drug reactions (ADRs). To describe the global ADRs profile of semaglutide using data from the World Health Organization’s (WHO) VigiAccess pharmacovigilance database. A retrospective descriptive analysis was conducted using publicly available ADR data retrieved from the WHO-VigiAccess portal on October 18, 2025. The total number and proportion of ADRs were summarized according to the Medical Dictionary for Regulatory Activities (MedDRA) system organ class (SOC). Demographic information, including age group, sex, geographic region, and reporting year, was reviewed descriptively. A total of 81,770 ADR reports associated with semaglutide were identified. The most frequently reported SOCs were gastrointestinal disorders (28%, n = 42,574), general disorders and administration site conditions (12%, n = 19,200), and injury, poisoning and procedural complications (11%, n = 16,601). Additional categories included nervous system disorders (8%), investigations (7%), and metabolism and nutrition disorders (7%). The majority of ADRs were reported among adults aged 45 to 64 years, with most originating from Europe and the Americas. Annual reporting increased markedly between 2018 and 2025, corresponding with expanded clinical use and obesity-related approvals. Global pharmacovigilance data indicate that semaglutide ADRs are primarily gastrointestinal and systemic in nature, consistent with its known pharmacological effects. Continuous monitoring is warranted to identify emerging safety signals and support optimized patient management as use expands worldwide.

Pharmacogenomics (PGx) uses genetic information to personalize medication, reducing adverse reactions and improving efficacy. Despite its promise, low public awareness and disparities in PGx acceptability among under-represented groups may exacerbate health inequalities. The objective of this study was to elucidate a British South Asian community's attitudes toward personalised prescribing. Adults of Bangladeshi or Pakistani ancestry from the Genes & Health (G&H) study completed a survey. Community feedback guided theme prioritization. Multivariable logistic regression analyses (controlling for age and gender) explored relationships among survey variables, and case-control Genome Wide Association Studies (GWAS) and candidate variant enrichment analysis examined the genetic architecture underlying herbal remedy use. Out of 553 respondents (57% female, mostly aged 25-54), 72% reported medication inefficacy, and 54% experienced side effects. Herbal remedies were widely used (66%), notably Black seed (39%), Turmeric (37%), and Ginger (36%). Participants who reported not using traditional or herbal medicines had higher medication adherence MARS-5 scores (Odds Ratio (OR) 1.10, 95% Confidence Interval (CI) 1.05-1.16, p < 0.0002). All three commonly used herbal remedies inhibit the pharmacogenomically variable CYP2C9 enzyme responsible for metabolising commonly used medications. 58% of respondents were willing to provide DNA samples for PGx testing, yet 70% agreed that they would be more likely to take medication as instructed if PGx results suggested the medicine would suit them. Concerns about PGx testing were common (27%), especially among non-English speakers. Most (69%) were concerned about misuse of PGx data, particularly by pharmaceutical companies (82%). Importantly, 87% demanded stronger PGx data protections compared to other health data. Compared to a national UK population, the surveyed subpopulation reported higher rates of adverse drug reactions (ADRs) and perceived medication inefficacy, yet fewer respondents indicated willingness to undergo PGx testing. This highlights the need for tailored implementation strategies and underscores the importance of engaging underrepresented populations in policy development. The inverse relationship between medication adherence and herbal remedy use indicates an association between cultural health practices and medication behaviours that merits further investigation. Increased awareness of the common use of these CYP2C9 inhibitors and further research into the genetic architecture underlying herbal remedy use are warranted.

Accurate prediction of drug-drug interactions (DDIs) is crucial for preventing adverse drug reactions and improving drug development efficiency. However, most existing DDI prediction models treat chemical structure and biological knowledge separately, failing to capture multiscale biological context. We present TRACE-DDI, a hybrid framework that integrates 3 complementary modalities within a single end-to-end architecture: (a) the Simplified Molecular Input Line Entry System (SMILES)-based chemical sequences, (b) molecular graph topology, and (c) pathway-anchored biological knowledge graphs. TRACE-DDI employs a Transformer-Graph Attention Network (GAT) cross-modal context encoder that performs multilayer graph-based feature propagation across heterogeneous biological representations, enabling both fine-grained chemical understanding and global pathway-level context aggregation. Experimental results on the benchmark dataset demonstrate that TRACE-DDI consistently outperforms state-of-the-art baselines across all major evaluation metrics. Beyond predictive accuracy, TRACE-DDI provides biologically interpretable insights: pathway-level subgraph visualization and centrality analysis prioritize shared pathway nodes that occupy prominent topological positions in merged drug subgraphs, thereby providing hypothesis-generating biological context for predicted DDIs. Together, TRACE-DDI establishes a unified and interpretable framework for biologically grounded DDI prediction and offers new directions for integrating actionable biological context into artificial intelligence-driven pharmacology.