Liver Int. 2025 Sep;45(9):e70255. doi: 10.1111/liv.70255.

ABSTRACT

BACKGROUND & AIMS: Immune checkpoint inhibitors (ICIs) are therapy for many malignancies including hepatocellular carcinoma (HCC), yet the impact of HCC on immune-mediated liver injury from checkpoint inhibitors (ILICI) remains poorly understood and no direct comparison exists for hepatotoxicity rates between ICI and sorafenib in HCC.

METHODS: In this retrospective cohort study, we extracted data on adult patients treated with five ICI regimens for HCC or non-HCC cancers, and HCC patients who received sorafenib between 2010 and 2020. The primary outcome was grade ≥ 3 ILICI or sorafenib (DILI). Logistic regression estimated adjusted odds ratios (OR) for liver injury.

RESULTS: We identified 530 patients, 129 (24%) HCC-ICI, 256 (48%) non-HCC ICI, and 145 (27%) HCC-sorafenib. Compared to non-HCC ICI, HCC-ICI and HCC-sorafenib were more often male (57%, 82%, 77%), Hispanic (14%, 35%, 34%), and cirrhotic (1%, 85%, 88%). Twenty-three patients developed grade ≥ 3 ILICI. ILICI incidence was higher for HCC-ICI (11%, CI 6-18) versus non-HCC ICI (4%, CI 2-6, p = 0.006) and DILI in HCC-sorafenib (3%, CI 1-8, p = 0.02) with incidence highest for ipilimumab-nivolumab (HCC-ICI 42%, CI 15-72 versus non-HCC 10%, CI 3-24; p = 0.02). On multivariable regression, ILICI was associated with HCC (OR 4.5, CI 1.8-11.4, p = 0.002) and treatment with ipilimumab-nivolumab (OR 6.9, CI 2.6-18.3, p < 0.001). Incidence of liver injury in HCC remained elevated for ICI versus sorafenib (OR 3.5, CI 1.2-10.4, p = 0.02).

CONCLUSIONS: We identified an elevated risk of liver injury in HCC patients receiving ICIs compared to ICI-treated non-HCC cancers and sorafenib-treated HCC, with dual ipilimumab-nivolumab therapy carrying the highest risk.

PMID:40778804 | DOI:10.1111/liv.70255

Pharmacol Res Perspect. 2025 Aug;13(4):e70164. doi: 10.1002/prp2.70164.

ABSTRACT

This study assessed whether the completeness of spontaneously reported adverse drug reaction (ADR) reports differs between consumers and healthcare professionals when submitted directly to regulators, and how this compares to reports from pharmaceutical companies. ADR reports (2014-2023) were obtained from public databases in Canada and the United Kingdom (UK), focusing on the medicine classes sodium-glucose cotransporter 2 inhibitors, glucagon-like peptide 1 receptor agonists, and dipeptidyl peptidase-4 inhibitors. ADR report completeness was assessed using vigiGrade tool variables. Descriptive statistics and chi-square tests were used for analysis. A total of 17 897 reports were analyzed-13 613 from the UK Yellow Card Scheme and 4284 from Canada. Most Canadian reports were submitted by pharmaceutical companies (55%), while in the UK, healthcare professionals submitted the majority (69%). Few reports were submitted directly by consumers in either Canada (4%) or the UK (7%). In Canada, the average completeness was 82% for consumer and healthcare professional reports and 57% for pharmaceutical companies. In the UK, completeness was 80% (consumers), 82% (healthcare professionals), and 69% (pharmaceutical companies). Canadian pharmaceutical company reports were significantly less complete for age, sex, outcome, dose, indication, and route of administration (all p < 0.001). In the UK, they were less complete for age, sex, and route of administration (all p < 0.001). In conclusion, reports submitted directly to regulators by consumers and healthcare professionals were more complete than those from pharmaceutical companies. The low consumer reporting rate, yet high completeness rate, highlights the need to encourage direct reporting to regulators to improve medicine safety monitoring.

PMID:40778745 | DOI:10.1002/prp2.70164

Front Public Health. 2025 Jul 24;13:1630412. doi: 10.3389/fpubh.2025.1630412. eCollection 2025.

ABSTRACT

BACKGROUND: Osteoporosis is a prevalent condition globally, often linked to a significant risk of fractures. Drug-induced osteoporosis (DIOP) is an increasingly recognized adverse effect of various medications, but the sex-specific risks and time-to-onset patterns remain inadequately understood. Addressing these gaps in knowledge is critical to improving patient safety and pharmacovigilance.

OBJECTIVE: This study aimed to explore sex-related differences in DIOP, identify high-risk medications, and assess the onset patterns of osteoporosis-related adverse events by analyzing data from the FDA Adverse Event Reporting System (FAERS) and validating the findings using the Canada Vigilance Adverse Reaction Online Database (Canada Vigilance ADR).

METHODS: We analyzed adverse event reports from the FAERS database covering the period from Q1 2004 to Q4 2024. Drugs were standardized using the RxNorm drug terminology system, and adverse events were matched to MedDRA 27.1. Disproportionality analysis was conducted using Reporting Odds Ratio (ROR), Multi-item Gamma Poisson Shrinker (MGPS), and Bayesian Confidence Propagation Neural Network (BCPNN) methods. To validate our findings, we performed external validation using the Canada Vigilance ADR database. Stratified analyses by sex were performed to assess differences in drug-osteoporosis associations.

RESULTS: A total of 236,928 osteoporosis-related reports were identified, with 64.6% of the reports coming from females. We identified 68 drugs associated with DIOP, including 15 male-specific and 26 female-specific potential risk drugs. Notable drugs such as tenofovir disoproxil and esomeprazole were linked to both sexes. Drugs like upadacitinib exhibited early-onset failure patterns, while others like tenofovir demonstrated cumulative risk patterns over prolonged use. External validation with the Canada Vigilance ADR confirmed 32 drugs with potential osteoporosis risks.

CONCLUSIONS: This study highlights important sex-specific differences in the risk of drug-induced osteoporosis and underscores the need for targeted pharmacovigilance strategies. The findings contribute to a more personalized approach to drug safety, promoting more informed decision-making regarding medication use in osteoporosis-prone populations.

PMID:40777658 | PMC:PMC12328446 | DOI:10.3389/fpubh.2025.1630412

Stud Health Technol Inform. 2025 Aug 7;329:1922-1923. doi: 10.3233/SHTI251280.

ABSTRACT

This study identifies key risk factors for immune-related adverse events (irAEs) in older cancer adults receiving immune checkpoint inhibitors (ICIs). Using the Flatiron Health database, the XGBoost model and SHAP analysis identified BMI, SES, ECOG score, sex, comorbidities, and pain score as significant predictors.

PMID:40776297 | DOI:10.3233/SHTI251280

Stud Health Technol Inform. 2025 Aug 7;329:1140-1144. doi: 10.3233/SHTI251017.

ABSTRACT

In this study, we combined automatically generated labels from large language models (LLMs) with a small number of manual annotations to classify adverse event-related treatment discontinuations in Japanese EHRs. By fine-tuning JMedRoBERTa and T5 on 6,156 LLM-labeled records and 200 manually labeled samples and then evaluating on a 100-record test set, T5 achieved a precision of 0.83, albeit with a recall of only 0.25. We noted that when training solely on the 200 human-labeled samples (that contained significantly few positive cases), the model failed to detect any adverse events, making a reliable measurement of precision or recall infeasible (that is, N/A). This underscores the potential of large-scale LLM-driven labeling as well as the need to improve recall and label quality in practical clinical scenarios.

PMID:40776035 | DOI:10.3233/SHTI251017

Stud Health Technol Inform. 2025 Aug 7;329:784-788. doi: 10.3233/SHTI250947.

ABSTRACT

Extracting nuanced adverse drug reactions (ADRs) from patient self-reported messages using is pivotal but challenging, particularly given HIPAA constraints. We investigate locally deployable small LLMs-Mistral-7B, Llama-3-8B, and Gemma-7B-for ADR extraction using the PsyTAR dataset of self-reported messages. We implement in-context learning, demonstration selection, and fine-tuning with QLoRA. Results show Mistral-7B excels in few-shot settings, and Fine-tuning with F1 = 86%. These approaches safeguard data privacy and offer resource-efficient solutions for healthcare organizations. Our pipeline enables real-time ADR monitoring, helping clinicians address concerns more swiftly and enhance patient outcomes. Findings underscore that smaller LLMs can be effectively used under strict data privacy constraints, allowing healthcare teams to quickly identify and address patient-reported ADRs. Ultimately, these accessible solutions bolster patient safety.

PMID:40775965 | DOI:10.3233/SHTI250947

Stud Health Technol Inform. 2025 Aug 7;329:703-707. doi: 10.3233/SHTI250931.

ABSTRACT

This study assessed the effectiveness of natural language processing (NLP) in detecting adverse events (AEs) from anticancer agents by analyzing data from over 39,000 cancer patients. A specialized machine learning model identified known AEs from anticancer agents like capecitabine, oxaliplatin, and anthracyclines, revealing a significantly higher incidence in the treatment groups compared to non-users. While the NLP approach effectively detected most symptomatic AEs requiring manual review, it struggled with rarely documented conditions and commonly used clinical terms. Overall, the method shows promise for automated AE detection in medical records, particularly for symptoms without laboratory markers or diagnosis codes.

PMID:40775949 | DOI:10.3233/SHTI250931

Stud Health Technol Inform. 2025 Aug 7;329:460-464. doi: 10.3233/SHTI250882.

ABSTRACT

Understanding cancer patients' experiences with medication safety events at home is crucial due to their impact on health outcomes. However, patients often face barriers to sharing this information with their clinicians. This study identified key factors influencing cancer patients' self-reporting behaviors through a mixed-methods approach, analyzing survey and interview data from 41 patients diagnosed with breast, lung, prostate, or colorectal cancer. Logistic regression analysis identified predictors such as beliefs about medication and perceived system usability, achieving an AUC of 0.85. Thematic analysis indicated that patients were more likely to report safety events when medications disrupted their daily routines, with perceived severity as the key trigger. System usability and relationships with clinicians also affected reporting behaviors. Our findings highlight the need for user-friendly reporting systems and supportive communication to improve patient engagement and medication safety, offering valuable insights for designing patient-centered reporting systems to facilitate patient-contributed data.

PMID:40775900 | DOI:10.3233/SHTI250882

Stud Health Technol Inform. 2025 Aug 7;329:450-454. doi: 10.3233/SHTI250880.

ABSTRACT

Adverse drug reactions are a significant concern in medical research and patient safety, and social media offers a valuable resource for broad and continuous monitoring of these reactions. However, extracting and analyzing relevant information about adverse drug reactions from social media poses several challenges for language models. Some challenges are linked to the characteristics of social media writing style, such as the use of hashtags, idiomatic expressions, and personal opinions. In this study, we identify these characteristics and investigate how language models perform in their presence in several languages. Our findings reveal that while current models can effectively classify some aspects of ADR-related content, significant challenges remain in accurately processing these social media-specific features. Further research is needed to enhance model performance and improve the reliability of ADR detection from social media data.

PMID:40775898 | DOI:10.3233/SHTI250880

Stud Health Technol Inform. 2025 Aug 7;329:352-356. doi: 10.3233/SHTI250860.

ABSTRACT

This study explores the potential of nursing records in improving pharmaceutical safety by analyzing adverse effects (AEs) using ChatGPT-4 for data categorization. A total of 927 anonymized records from a Japanese community hospital were analyzed through a three-stage protocol: identifying AEs using ChatGPT-4, constructing a co-occurrence network to analyze relationships among key terms, and identifying central patterns using network metrics. Results revealed a high proportion of entries classified as "Unknown" for both AE status (674 cases) and patient conditions (865 cases), highlighting documentation gaps. The most frequently documented medicines were Red Blood Cells (123 instances) and Fresh Frozen Plasma (87 instances), while Thermal Therapy (30 instances) and CT Scans (23 instances) were the most used medical devices. However, AE documentation was limited, with only 6 cases for medicines and 2 for devices. The co-occurrence network emphasized the importance of informed consent (IC) in communicating treatment risks, particularly in chemotherapy and antibiotic use. Despite challenges, this study underscores the critical role of nursing records in AE management and calls for standardized documentation and integration. Future efforts could explore combining large language models with human-in-the-loop feedback to further improve AE extraction accuracy from incomplete nursing notes. into clinical workflows to enhance patient safety.

PMID:40775878 | DOI:10.3233/SHTI250860

Ren Fail. 2025 Dec;47(1):2540563. doi: 10.1080/0886022X.2025.2540563. Epub 2025 Aug 7.

ABSTRACT

Medications contribute to about a quarter of acute kidney injury (AKI) cases among patients in hospitals. The impact of AKI is substantial on both families and society, and it has become a worldwide public health concern. Recently, a new framework for drug-induced acute kidney injury (DI-AKI) classification has been proposed. According to this new framework, drugs are divided into four categories. Thus, we explain the mechanism thoroughly and give examples of drugs or drug categories linked to the classes in the new framework. Furthermore, a patient's condition may dynamically shift between categories. At the same time, we also took into account some susceptibility factors. These susceptibility factors may drive inter-class variation. The new classification system may shed new light on the mechanism of DI-AKI for clinicians and researchers.

PMID:40775804 | DOI:10.1080/0886022X.2025.2540563

Orphanet J Rare Dis. 2025 Aug 7;20(1):406. doi: 10.1186/s13023-025-03934-7.

ABSTRACT

OBJECTIVE: This study aims to evaluate the adverse drug reactions associated with imiglucerase in the treatment of Gaucher disease by analyzing data from the FDA Adverse Event Reporting System (FAERS) database.

METHODS: A comprehensive analysis was conducted on 166,800,135 adverse event reports from the FAERS database, covering the period from the first quarter of 2004 to the fourth quarter of 2023. The data were processed using R software and analyzed using multiple disproportionality methods, including Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-Item Gamma Poisson Shrinker (MGPS). These methodologies were applied to identify significant adverse reaction signals across various System Organ Classes (SOCs) and Preferred Terms (PTs).

RESULTS: The analysis revealed significant adverse reaction signals in multiple SOCs, including general disorders and administration site conditions, injury, poisoning and procedural complications, infections and infestations, and nervous system disorders. Notably, general disorders and injury-related conditions had the highest number of reports. At the PT level, the term "Gaucher disease" yielded the highest statistical signal. This was identified as a critical reporting artifact, likely representing perceived treatment failure or disease progression, rather than a true adverse reaction. After accounting for this artifact, other significant adverse event signals included increased chitotriosidase, elevated acid phosphatase, and bone infarction, with musculoskeletal and connective tissue disorders being a key area of concern. A comparative analysis against other Gaucher therapies suggests this strong skeletal signal likely reflects confounding by indication rather than a drug-specific risk.

CONCLUSION: The findings underscore the importance of ongoing pharmacovigilance to monitor the safety of imiglucerase, especially among vulnerable populations such as pregnant women, long-term users, and those with comorbid hepatobiliary or skeletal conditions.

PMID:40775785 | DOI:10.1186/s13023-025-03934-7

BMC Prim Care. 2025 Aug 7;26(1):248. doi: 10.1186/s12875-025-02926-7.

ABSTRACT

BACKGROUND: Community pharmacies (CPs) are key healthcare providers, playing a significant role in optimizing drug therapy and preventing drug-related problems (DRPs). This study aims to assess the prevalence, characteristics, and related factors of DRPs in Turkish patients in the community pharmacy setting.

METHODS: A cross-sectional, prospective study was conducted between December 2023 and December 2024 in a community pharmacy. A total of 100 patients were included after excluding those with incomplete data. DRPs were evaluated using the PCNE V9.1 classification system, while Medication Adherence Report Scale (MARS) and Medication Regimen Complexity Index (MRCI) were used to assess adherence and regimen complexity.

RESULTS: A total of 162 DRPs were identified, with an average of 1.6 DRPs per patient. DRPs were significantly associated with factors such as higher body mass index (p = 0.005), polypharmacy (p < 0.001), use of antidiabetic (p < 0.001) and antihypertensive medications (p = 0.005), and a higher number of comorbidities (p = 0.005). No significant relationship was observed between medication adherence and DRPs (p > 0.05).

DISCUSSION: This study is among the first in Türkiye to evaluate DRPs in chronic disease management within a community pharmacy setting. The findings highlight the importance of clinical pharmacists in identifying and managing DRPs and suggest the need for integrated interventions in healthcare teams to improve patient outcomes and medication safety.

PMID:40775745 | DOI:10.1186/s12875-025-02926-7

BMC Gastroenterol. 2025 Aug 7;25(1):560. doi: 10.1186/s12876-025-04154-w.

ABSTRACT

BACKGROUND: The incidence of pediatric inflammatory bowel disease (IBD) significantly increased recently. Infliximab (IFX) and adalimumab (ADA), both TNF-α inhibitors, are the only FDA-approved treatments for pediatric IBD. Due to the unique physiological and developmental characteristics of children, postmarketing pharmacovigilance requires ongoing attention. We aimed to evaluate the safety of IFX and ADA in pediatric IBD using FAERS database data from Q1 2004 to Q1 2024.

METHODS: Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR) algorithms were used to identify drug-related adverse events (AEs).

RESULTS: In total, we retrieved 10,905 IFX-related reports and 5,446 ADA-related reports in pediatric IBD. Common AEs associated with IFX were infusion reactions; for ADA, they were injection site reactions. While most AEs align with approved labeling, continued vigilant monitoring appears important for specific postmarketing AEs observed with IFX, including suicide attempts, weight increased, and psoriasis. The median onset (TTO) for IFX-related AEs was 579 days (interquartile range [IQR]: 159.25-1357 days), occurring mostly after 360 days. For ADA, TTO was 79 days (IQR: 21.75-295 days), with most within 90 days of treatment initiation.

CONCLUSION: Our study revealed that although most AEs matched labeled information, rigorous post-marketing monitoring of severe AEs remains important for IFX and ADA in pediatric IBD, with additional confirmatory research warranted.

PMID:40775680 | DOI:10.1186/s12876-025-04154-w

Int J Clin Pharm. 2025 Aug 7. doi: 10.1007/s11096-025-01977-1. Online ahead of print.

ABSTRACT

BACKGROUND: The potentially inappropriate medications (PIM)-China criteria, published in 2017, require updates to reflect new therapeutic evidence and address limitations such as outdated medications and condition-specific considerations.

AIM: This study aimed to develop an updated version of the PIM-China criteria through a modified Delphi consensus methodology, ensuring evidence-based and clinically relevant recommendations for older adults in China.

METHOD: A literature review of six PIM criteria (Beers, STOPP, FORTA, EU(7)-PIM, Japan and Korea criteria) and relevant literature (2018-2023) informed a preliminary list of PIMs. A multidisciplinary panel of 33 experts, comprising 12 physicians and 21 pharmacists, evaluated 210 candidate criteria over three Delphi rounds. Statistical measures were used to validate consensus, including Kendall's W, coefficient of variation (CV), and expert authority coefficient (Cr). Cr values ≥ 0.80 indicated high reliability, while Kendall's W > 0.20 signified moderate to strong agreement.

RESULTS: The updated criteria consist of 154 items, a 57% increase from 2017, including 100 individual medications or drug classes and 54 condition-specific PIMs. Notable additions include recommendations addressing drug-drug interactions, renal function adjustments, and alternative treatments. Consensus improved significantly across rounds, with Kendall's W increasing from 0.145 to 0.271 for individual PIMs and 0.118 to 0.360 for condition-specific PIMs (P < 0.05). Cr reached 0.85, reflecting the panel's high authority.

CONCLUSION: The updated 2024 PIM-China criteria enhance prescribing safety and clinical relevance by incorporating new evidence and expert consensus. These criteria are vital for reducing adverse drug events, optimizing prescribing practices, and improving healthcare for older adults in China.

PMID:40775482 | DOI:10.1007/s11096-025-01977-1

Sci Rep. 2025 Aug 7;15(1):28886. doi: 10.1038/s41598-025-13786-7.

ABSTRACT

Vortioxetine is an antidepressant approved for the treatment of major depressive disorder (MDD). Given its widespread post-marketing clinical use, it is essential to explore its real-world safety. Reports were extracted from the FDA Adverse Event Reporting System (FAERS) from the third quarter of 2013 to the first quarter of 2025. Four disproportionality analysis methods, commonly used in pharmacovigilance to evaluate the relative reporting frequency of adverse events (AEs), were employed to identify AE signals associated with vortioxetine. These included the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Multi-item Gamma Poisson Shrink (MGPS), and Bayesian Confidence Propagation Neural Network (BCPNN). The median was used to describe the time to onset (TTO) of AEs, and Weibull distribution was employed to assess the trend of AE occurrence over time. In addition, sensitivity analyses were conducted to ensure the robustness of the findings. A total of 13,613 individual case safety reports (ICSRs) involving 34,156 AEs were analyzed. Females accounted for 60.9% of the reports, while males represented 26.5%. The median age of patients was 42 years (interquartile range: 26-59 years), with most cases (34.1%) in the 18-65 age group. The United States contributed the highest proportion of reports (77.4%). Common AEs included nausea (n = 2042, ROR = 5.11, PRR = 4.86, EBGM = 4.85, IC = 2.28), anxiety (n = 781, ROR = 5.3, PRR = 5.2, EBGM = 5.18, IC = 2.37 ), vomiting (n = 773, ROR = 3.23, PRR = 3.17, EBGM = 3.17, IC = 1.66), headache (n = 670, ROR = 1.96, PRR = 1.94, EBGM = 1.94, IC = 0.96), and somnolence (n = 212, ROR = 2, PRR = 1.99, EBGM = 1.99, IC = 0.99). Notably, several AEs not listed on the drug label, such as tinnitus (n = 79, ROR = 3.24, PRR = 3.24, EBGM = 3.23, IC = 1.69), urinary retention (n = 62, ROR = 3.57, PRR = 3.57, EBGM = 3.56, IC = 1.83), prolonged QT interval (n = 62, ROR = 3.14, PRR = 3.13, EBGM = 3.13, IC = 1.64), and restless legs syndrome (n = 48, ROR = 5.08, PRR = 5.08, EBGM = 5.06, IC = 2.34) were also identified. Most AEs occurred within the first month of treatment, with a median onset time of 15 days. Sensitivity analyses confirmed the consistency of these findings. This study provides new insights into the safety of vortioxetine and offers preliminary safety evidence. In addition, the findings may inform updates to prescribing information and guide post-marketing safety surveillance. However, the spontaneous nature of the FAERS database precludes establishing a causal relationship between vortioxetine and the reported AEs. Further prospective studies are needed to validate our findings.

PMID:40775011 | DOI:10.1038/s41598-025-13786-7

Sci Rep. 2025 Aug 7;15(1):28919. doi: 10.1038/s41598-025-14385-2.

ABSTRACT

Viloxazine and dextroamphetamine as newly approved drugs for the medical treatment of Attention Deficit Hyperactivity Disorder (ADHD) in recent years give new options for the treating of related disorders, including anxiety, and depression. In our research, we conducted an assessment of adverse drug reactions (ADRs) associated with the utilization of these two medications, as documented in the database. By analyzing the adverse drug reaction profiles and combining them with relevant reviews, we aim to help select the drug with the least risk to meet the specific needs of different patients. A retrospective descriptive analysis method was used in this study. The study classified two ADHD medications and extracted adverse drug reaction (ADR) reports for these medications from the World Health Organization-VigiAccess database. Data collected included patient demographic characteristics such as gender and age group, as well as geographic distribution based on global ADR reports. We compared the similarities and differences between the ADRs of the two drugs by calculating the proportion of ADRs reported for each drug. Finally, we also compared the most common general disorders and administration site conditions for various adverse effects. VigiAccess reported a total of 5394 adverse events (AEs) related to these two drugs. The most commonly reported age group was between 18 and 44 years and the three most common types of AEs were: general disease and site of administration conditions (2,548 cases, 20.5%), psychiatric disorders (2,012 cases, 16.1%) and neurologic disorders (1,822 cases, 14.6%). Dextroamphetamine had a significantly higher rate of reported adverse reactions in general disorders and administration site conditions compared to viloxazine. Beyond that there are other differences that exist. Using real-world data from WHO-VigiAccess and FAERS, we identified existing potential adverse reactions associated with viloxazine and dextroamphetamine, providing valuable insights for clinical reference. Although the study benefits from database utilization, its limitation lies in the spontaneous reporting system. Accurate drug safety evaluation requires future enhancements.

PMID:40775008 | DOI:10.1038/s41598-025-14385-2

PLoS One. 2025 Aug 7;20(8):e0329088. doi: 10.1371/journal.pone.0329088. eCollection 2025.

ABSTRACT

BACKGROUND: Osilodrostat is a medication recently approved for the treatment of Cushing's syndrome. However, there is a current dearth of large-scale studies on the adverse events associated with Osilodrostat. Consequently, this study aims to comprehensively evaluate these adverse events using data from the FDA Adverse Event Reporting System (FAERS).

METHODS: A disproportionality analysis was utilized to identify signals of adverse events linked to Osilodrostat. Furthermore, a Weibull distribution analysis was conducted to evaluate the temporal evolution of adverse events, and subgroup analyses were performed. The Wilcoxon test was applied to investigate differences in the temporal patterns of adverse events across different genders.

RESULTS: A total of 1,078 cases related to Osilodrostat were identified, including 3,744 adverse events. The most frequent and severe signals of adverse events were investigations, off-label use, fatigue, nausea, and adrenal insufficiency. The median time to onset of adverse events related to Osilodrostat was 52 days after starting the medication. There was a gender difference in the median time to onset of adverse events, with a median of 15 days for males and 34 days for females.

CONCLUSION: This study provides a comprehensive evaluation of adverse events related to Osilodrostat, confirming some known side effects and revealing other potential risks. This information offers valuable insights for the clinical application of Osilodrostat.

PMID:40773444 | DOI:10.1371/journal.pone.0329088

Sr Care Pharm. 2025 Aug 1;40(8):306-314. doi: 10.4140/TCP.n.2025.306.

ABSTRACT

With the increasing prevalence of polypharmacy, age-related physiological changes, and the need for individualized pharmacotherapy in older patients, understanding new drug approvals is crucial to optimizing medication management. This paper synthesizes the latest evidence and offers insights into prescribing considerations, potential drug-drug interactions, and strategies to mitigate adverse effects. We believe this work will be of significant interest to health care professionals, including pharmacists, physicians, and geriatric specialists, as they navigate the evolving landscape of pharmacotherapy in older adults.

PMID:40770590 | DOI:10.4140/TCP.n.2025.306

Sci Rep. 2025 Aug 7;15(1):28849. doi: 10.1038/s41598-025-13234-6.

ABSTRACT

Myocarditis and pericarditis are managed with various treatments, yet prior studies and case reports indicate that certain drug classes may elevate the risk for these inflammatory cardiac conditions. This research aimed to systematically identify the leading drugs most frequently associated with myocarditis and pericarditis cases. Analyses were carried out using the global database of individual case safety reports from 1968 to 2024. We identified the drugs most frequently reported in signal detection with myocarditis and pericarditis, selecting the top 10 drugs based on record count, excluding those used in the treatment of inflammatory cardiac conditions to avoid potential confounding. Two statistical indicators, the information component (IC) with IC025 and reporting odds ratio (ROR) with 95% confidence interval (CI) were used to conduct the disproportionality analysis in this study. The following five drugs were consistently observed with both myocarditis and pericarditis: clozapine, mesalazine, smallpox vaccine, influenza vaccine, and COVID-19 mRNA vaccine. The other leading drugs differed by condition, with nivolumab, pembrolizumab, ipilimumab, valproate, and metronidazole appearing more frequently for myocarditis, and ribavirin, sulfasalazine, methotrexate, omalizumab, and heparin for pericarditis. Each of these drugs showed a significant signal detection with myocarditis (ROR, 83.22 [95% CI, 81.17-85.33]; IC, 3.96 [IC025, 3.94]) and pericarditis (42.16 [41.19-43.16]; 3.66 [3.64]). Although our findings did not allow for causal inference, these findings highlight the importance of monitoring for possible adverse carditis cases when prescribing these drugs. Further studies are encouraged to investigate underlying mechanisms, assess individual patient risk factors, and explore the long-term impacts associated with myocarditis and pericarditis in relation to drug.

PMID:40770014 | DOI:10.1038/s41598-025-13234-6