Selin Akturk Esen, Dogan Uncu, Mehmet Ali Nahit Sendur
{"title":"Long-term cardiotoxicity outcomes of trastuzumab and cardiac safety of novel HER2-targeted therapies.","authors":"Selin Akturk Esen, Dogan Uncu, Mehmet Ali Nahit Sendur","doi":"10.1080/14740338.2026.2667402","DOIUrl":"https://doi.org/10.1080/14740338.2026.2667402","url":null,"abstract":"<p><strong>Introduction: </strong>Cardiotoxicity associated with HER2-targeted therapies represents an important clinical concern in the management of HER2-positive breast cancer, particularly as survival improves and patients are exposed to prolonged or sequential treatments. Trastuzumab has significantly enhanced outcomes but is associated with cardiac dysfunction, which may limit its use in patients with preexisting cardiovascular risk factors. With the expanding use of newer HER2-targeted agents, a clear understanding of their cardiac safety profiles is essential for optimizing long-term patient care.</p><p><strong>Areas covered: </strong>This review evaluates the incidence, mechanisms, and clinical relevance of cardiotoxicity associated with trastuzumab and novel HER2-targeted therapies, including monoclonal antibodies, antibody - drug conjugates, and tyrosine kinase inhibitors. A literature search was conducted using PubMed and major oncology meeting proceedings, including the American Society of Clinical Oncology (ASCO) Annual Meeting and the San Antonio Breast Cancer Symposium. Randomized clinical trials, pooled analyses, long-term follow-up studies, and selected real-world observational studies reporting cardiac outcomes were reviewed.</p><p><strong>Expert opinion: </strong>Available evidence suggests that trastuzumab-related cardiotoxicity remains clinically relevant, whereas newer HER2-targeted agents generally demonstrate favorable cardiac safety profiles with mostly asymptomatic and reversible events. These findings support individualized, risk-adapted cardiac monitoring strategies to balance oncologic efficacy with cardiovascular safety.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2026-05-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147812885","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Vancomycin and linezolid: severe cutaneous adverse reactions to drugs.","authors":"Chen-Sui-Zi Li, Mei-Fen Han, Bing Yu, Qian Gao, Hong-Liang Dong, Zhi-Ling Li","doi":"10.1080/14740338.2024.2442023","DOIUrl":"10.1080/14740338.2024.2442023","url":null,"abstract":"<p><strong>Background: </strong>Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), and Acute Generalized Exanthematous Pustulosis (AGEP), pose significant therapeutic challenges. Vancomycin and linezolid have been linked to these life-threatening conditions, necessitating a better understanding of their associated risks.</p><p><strong>Methods: </strong>We conducted a retrospective analysis using data from the FDA Adverse Event Reporting System (FAERS) database. Disproportionality and Bayesian statistical analyses were applied to evaluate the associations between vancomycin, linezolid, and SCARs, comparing the outcomes induced by these drugs.</p><p><strong>Results: </strong>Of the 11,737,133 data, there were a total of 1024 vancomycin-associated SCARs and 125 cases of linezolid-associated SCARs. Vancomycin was strongly associated with DRESS, showing a Reporting Odds Ratio (ROR) of 53.79 (95% CI: 49.75-58.16), Proportional Reporting Ratio (PRR) of 50.38, and Empirical Bayesian Geometric Mean (EBGM) of 2.32. For SJS and TEN, vancomycin reported RORs of 8.04 and 15.63, respectively. Linezolid demonstrated lower associations, with RORs of 5.14 for DRESS and 2.36 for SJS.</p><p><strong>Conclusions: </strong>Vancomycin presents a higher risk of SCARs compared to linezolid, particularly for DRESS. Underscoring the need for cautious use and the potential benefit of personalized medicine practices to improve patient safety.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"973-980"},"PeriodicalIF":3.1,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142817685","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Potential risk analysis of antipsychotics-related constipation from the FDA Adverse Event Reporting System.","authors":"Sidi He, Chuanwei Li","doi":"10.1080/14740338.2025.2468857","DOIUrl":"10.1080/14740338.2025.2468857","url":null,"abstract":"<p><strong>Background: </strong>Antipsychotics-related constipation is a frequently neglected and poorly researched adverse effects in patients in clinical practice. Constipation not only affects the physical health of patients but also increases the psychological stress to their disease burden, so it requires more attention.</p><p><strong>Methods: </strong>We queried adverse event reports of antipsychotics-related constipation from the FDA Adverse Event Reporting System (FAERS) database between January 2017 and December 2022. The report odds ratio (ROR) and 95% confidence intervals (CIs) were calculated using case/non-case methods.</p><p><strong>Results: </strong>A total of 562 constipation cases were attributed to atypical antipsychotics (AAPs) during the study period. Except for aripiprazole and ziprasidone, the <i>p</i> values of the other drugs were all less than 0.05. The RORs values in descending order: amisulpride (ROR = 4.07), paliperidone (ROR = 2.73), quetiapine (ROR = 1.83), clozapine (ROR = 1.61), olanzapine (ROR = 1.50), risperidone (ROR = 0.71).</p><p><strong>Conclusion: </strong>This study found that clozapine, olanzapine, amisulpride, quetiapine, and paliperidone were correlated with constipation, while risperidone had the least effect on gastrointestinal function. Future analysis of the FAERS database in conjunction with other data sources will be essential for continuous monitoring of antipsychotics-related constipation.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"857-862"},"PeriodicalIF":3.1,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143440409","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The importance and utility of post market drug safety monitoring in cancer therapy.","authors":"Dominique Levêque","doi":"10.1080/14740338.2025.2575099","DOIUrl":"10.1080/14740338.2025.2575099","url":null,"abstract":"<p><strong>Introduction: </strong>Most of the new agents in cancer therapy (referred to as targeted therapies in the paper) come to the market with limited and preliminary data concerning activity and tolerance. Although better tolerated than classical chemotherapy, safety issues of targeted agents must not be underestimated.</p><p><strong>Areas covered: </strong>The aim of this mini review is to present some pharmacological specifities of targeted anticancer agents and to examine tolerance challenges observed after approval through some examples. References were identified through searches of PubMed for articles published up to March 2025 using the term postmarketing safety AND anticancer agent. Relevant articles were also searched for in high impact journals and specialty journals.</p><p><strong>Expert opinion: </strong>Considering the clinical immaturity of targeted agents at their launch, partly due to expedited approvals, the new mechanisms of cell killing and the novel technologies of manufacturing, the postmarketing safety surveillance is a critical feature to secure their use. Pharmacoepidemiologic studies based on electronic health-based data will help to identify emergent and late safety events and to investigate their etiology along with predisposition factors. Work is also needed to elucidate the sex differences in toxicity of targeted therapies and to harmonize withdrawal decisions of drug regulatory agencies for safety reasons.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"823-835"},"PeriodicalIF":3.1,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145299403","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The antidepressants and sexual dysfunction: a pharmacovigilance-pharmacodynamic study of the FDA adverse event reporting system.","authors":"Yu Cheng, Youjun Chen, Xue Zhao, Fan Mou, Yingting Tan, Wanying Wang, Ruiyi Qian, Qingqing Xu, Shunying Yu","doi":"10.1080/14740338.2024.2443956","DOIUrl":"10.1080/14740338.2024.2443956","url":null,"abstract":"<p><strong>Background: </strong>Sexual dysfunction (SD) is a commonly occurring yet often underestimated adverse event associated with the use of antidepressants. This study aimed to analyze the reporting of SD associated with the use of antidepressants in comparison with one another, and to explore potential receptor mechanisms based on the real-world data from the Food and Drug Administration Adverse Event Reporting System (FAERS).</p><p><strong>Methods: </strong>Disproportionality analysis was conducted based on FAERS reports (2004 Q1 to 2024 Q2) using reporting odds ratios (ROR) and information components (IC) methods. Spearman correlation analysis was performed to explore the relationship between ROR and the related receptor-binding properties.</p><p><strong>Results: </strong>In total, 233 significant signals involving 9767 cases were included. The analysis confirmed that the selective serotonin reuptake inhibitors and serotonin-norepinephrine reuptake inhibitors exhibited significant signals, consistent with previous research. Additionally, unexpected signals were detected for vortioxetine (ROR = 13.60), suggesting a potential risk despite its low reported incidence rates of SD. Spearman correlation analysis revealed potential effects for the binding affinities of serotonin transporter, 5-HT1B, and 5-HT2A receptors on reduced sexual desire.</p><p><strong>Conclusions: </strong>The present investigation has detected new and unexpected signals of antidepressant-related SDs. Further research is needed to validate and clarify the observed associations.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"897-907"},"PeriodicalIF":3.1,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142853617","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Shu Zhou, Li Lei, Ling Jiang, Chuhan Fu, Jiangfeng Huang, Keyi Zhang, Yaqing Wen, Jing Chen, Qinghai Zeng
{"title":"Adverse event of ruxolitinib cream: a real-world analysis based on FDA Adverse Event Reporting System from 2021 to 2024.","authors":"Shu Zhou, Li Lei, Ling Jiang, Chuhan Fu, Jiangfeng Huang, Keyi Zhang, Yaqing Wen, Jing Chen, Qinghai Zeng","doi":"10.1080/14740338.2024.2446432","DOIUrl":"10.1080/14740338.2024.2446432","url":null,"abstract":"<p><strong>Background: </strong>Ruxolitinib cream, a topical Janus kinase (JAK) inhibitor, is a widely used treatment for various dermatological diseases. This study employs the FDA Adverse Event Reporting System (FAERS) database to examine adverse events (AEs) associated with ruxolitinib cream.</p><p><strong>Methods: </strong>This study employed disproportionate analysis methods, including reported odds ratio and proportional reporting ratio, to collate AEs reported from the fourth quarter of 2021 to the first quarter of 2024.</p><p><strong>Results: </strong>After data processing, 803 reports involving ruxolitinib cream were analyzed. Statistically significant signals were identified for 4 system organ classes (SOCs) and 29 preferred terms (PTs). The most notable signal observed in the SOCs was associated with skin and subcutaneous tissue disorders. For PTs, the AEs observed included clinical symptoms such as pruritus, skin irritation, and burning sensations, as well as signs such as rash, scratching, erythema, and dry skin. Additionally, other observed AEs included diseases such as acne, drug hypersensitivity, and herpes zoster.</p><p><strong>Conclusions: </strong>This study offers insights into the safety of ruxolitinib cream, improving understanding of its AEs and guiding safer clinical practices. However, the FAERS database lacks data on AE severity and the ability to establish causality, requiring further research to clarify mechanisms behind certain AEs.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"981-986"},"PeriodicalIF":3.1,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142871951","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"What are the main cardiovascular risks of ADHD medications?","authors":"Samuele Cortese, Zheng Chang, Henrik Larsson","doi":"10.1080/14740338.2025.2588601","DOIUrl":"10.1080/14740338.2025.2588601","url":null,"abstract":"","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"809-811"},"PeriodicalIF":3.1,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145481205","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Brad Jordan, Luke Arbogast, Matthew Clemens, Lihua Huang, Matthew Snyder
{"title":"A novel, widespread impurity in mass-compounded tirzepatide/B12 products: potential patient safety implications.","authors":"Brad Jordan, Luke Arbogast, Matthew Clemens, Lihua Huang, Matthew Snyder","doi":"10.1080/14740338.2026.2663185","DOIUrl":"10.1080/14740338.2026.2663185","url":null,"abstract":"<p><strong>Background: </strong>Compounded versions of tirzepatide are widely available in the U.S. in the form of fixed‑dose combinations of tirzepatide and various analogs of vitamin B12. These combinations are mass marketed in the U.S. and other countries as comparable to FDA‑approved tirzepatide products even though they undergo no evaluation of their potency or impurity profiles.</p><p><strong>Research design and methods: </strong>Samples of compounded tirzepatide combined with B12 obtained from various sources in the U.S. market were tested using various analytical methods. Samples were assessed for unacceptable levels of peptide-related impurities.</p><p><strong>Results: </strong>Our testing identified a widespread and previously unidentified impurity in compounded tirzepatide-B12 products resulting from a chemical reaction between tirzepatide and certain analogs of B12.</p><p><strong>Conclusion: </strong>Despite the presence of this impurity, these products continue to be mass marketed as 'personalized' treatments. Our findings underscore the importance of testing and FDA approval before new drugs are marketed and highlight potential risks for patients associated with untested combinations. A novel impurity, present at substantial levels in compounded tirzepatide/B12 products, highlights risks inherent in marketing complex therapies outside the drug‑approval framework. Although clinical effects of this impurity are unknown, the identification of a widespread impurity adds to the existing quality concerns presented by compounded tirzepatide.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"837-845"},"PeriodicalIF":3.1,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147728713","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Gen Ba, Weiwen Hao, Qifang Shi, Hao Sun, Hua Jin, Meng Li, Yun Cao, Jie Qiao, Min Xie, Juan Zhou, Zhenzhen Huang, Zihao Wang, Ying Zhou, Guiping Jiang, Jinsong Zhang
{"title":"Epidemiological investigation of adult emergency infusion adverse drug reactions (EIADR) in Nanjing, China: a prospective cross-sectional study (EIADR II).","authors":"Gen Ba, Weiwen Hao, Qifang Shi, Hao Sun, Hua Jin, Meng Li, Yun Cao, Jie Qiao, Min Xie, Juan Zhou, Zhenzhen Huang, Zihao Wang, Ying Zhou, Guiping Jiang, Jinsong Zhang","doi":"10.1080/14740338.2024.2443789","DOIUrl":"10.1080/14740338.2024.2443789","url":null,"abstract":"<p><strong>Objective: </strong>To analyze the clinical characteristics of adverse drug reactions (ADRs) in adults receiving emergency infusions at a tertiary hospital.</p><p><strong>Methods: </strong>We conducted a prospective observational cohort study involving 585 adult patients who experienced adverse drug reactions (ADRs) between 20 November 2019, and 20 November 2023, during intravenous infusions in the emergency infusion room of a tertiary hospital. The analysis included patients' gender, age, type of drugs involved, organ-system involvement, clinical manifestations of ADRs, severity grading of ADRs, and preventability of ADRs.</p><p><strong>Results: </strong>The highest percentage of ADRs occurred in the 30-39 age group. Antimicrobials were the most common cause of ADRs, with skin manifestations being the predominant clinical feature. Approximately 23.93% of ADRs were deemed preventable.</p><p><strong>Conclusion: </strong>Monitoring ADRs related to antimicrobials is crucial in adult emergency infusions. The 30-39 age group is particularly susceptible to ADRs. Preventive measures and a well-established Electronic Health Record (EHR) system can effectively reduce ADRs incidence.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"873-879"},"PeriodicalIF":3.1,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142827945","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Li Lin, Xinlei Zheng, Min Wu, Yan Chen, Qichun Nian, Yu Lin, Maohua Chen
{"title":"A real-world disproportionality analysis of FDA Adverse Event Reporting System (FAERS) events for ramucirumab.","authors":"Li Lin, Xinlei Zheng, Min Wu, Yan Chen, Qichun Nian, Yu Lin, Maohua Chen","doi":"10.1080/14740338.2024.2441286","DOIUrl":"10.1080/14740338.2024.2441286","url":null,"abstract":"<p><strong>Background: </strong>Ramucirumab (IMC-1121B) is a fully human immunoglobulin G1 monoclonal antibody, approved by the US Food and Drug Administration (FDA) for treating various cancers, including gastric, colorectal, liver, and non-small cell lung cancer. This study aimed to investigate the adverse events (AEs) associated with ramucirumab by utilizing data mining techniques on the FDA Adverse Event Reporting System (FAERS).</p><p><strong>Methods: </strong>We collected ramucirumab-related data from the FAERS database, spanning from January 2014 to June 2023. Our analysis incorporated both Frequentist and Bayesian methodologies in disproportionality analysis to determine the relationship between the drug and specific AEs.</p><p><strong>Results: </strong>Among the 14,605,547 reports in FAERS database, 12,692,407 were identified as primary suspected AEs related to ramucirumab. These AEs involved 26 different organ systems, with 24 significant disproportionality Preferred Terms (PTs) identified across four algorithms. Notably, unexpected significant AEs, such as peripheral neuropathy, hemolytic uremic syndrome, rectal stenosis, anaphylactic shock, bladder tamponade, hydronephrosis, and spontaneous pneumothorax, were also observed.</p><p><strong>Conclusion: </strong>This study makes a significant contribution to the field by emphasizing the importance of long-term monitoring of approved agents to further expand on potential adverse events and to distinguish between events that are disease-related versus those more directly related to the particular treatment.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"987-996"},"PeriodicalIF":3.1,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142800122","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}