{"title":"Drug-induced Guillain-Barré Syndrome: a disproportionality analysis based on the US FDA adverse event reporting system.","authors":"Rujia Zhong, Jiahao Li, Feng Zhang, Yi Guo","doi":"10.1080/14740338.2025.2493781","DOIUrl":"https://doi.org/10.1080/14740338.2025.2493781","url":null,"abstract":"<p><strong>Background: </strong>Guillain-Barré Syndrome (GBS) is a rare but severe neurological disorder often precipitated by infections, vaccines, and potentially by certain medications. Drug-induced GBS, though less commonly reported, presents significant diagnostic and therapeutic challenges. This study investigates the correlation between various medications and the onset of GBS.</p><p><strong>Research design and methods: </strong>We conducted a retrospective pharmacovigilance analysis using data from the FDA Adverse Event Reporting System (FAERS) from Q1 2004 to Q1 2024. The analysis focused on identifying drugs frequently associated with GBS and examining the time-to-onset and severity of these events.</p><p><strong>Results: </strong>From over 17 million adverse events, 1,869 cases were identified as drug-induced GBS. Monoclonal antibodies and immunomodulators were the most frequently implicated drug classes. The median time-to-onset for GBS was within the first 30 days following drug exposure. Approximately 51.8% of the cases resulted in severe outcomes, such as hospitalization or disability. Drugs such as brentuximab vedotin and efalizumab showed strong associations with GBS occurrences.</p><p><strong>Conclusions: </strong>This study highlights the importance of monitoring for GBS symptoms following the administration of certain medications, particularly those that affect immune function, and underscores the need for healthcare providers to be aware of the potential neurological risks associated with these medications.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-9"},"PeriodicalIF":3.0,"publicationDate":"2025-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143960760","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}
Mei Zhan, Qinran Long, Jinhan He, Litao Huang, Ran Liu, Bin Wu, Ting Xu
{"title":"Pancreatic adverse events induced by immune checkpoint inhibitors: a real-world observational study.","authors":"Mei Zhan, Qinran Long, Jinhan He, Litao Huang, Ran Liu, Bin Wu, Ting Xu","doi":"10.1080/14740338.2025.2493783","DOIUrl":"https://doi.org/10.1080/14740338.2025.2493783","url":null,"abstract":"<p><strong>Background: </strong>Immune checkpoint inhibitor (ICI)-induced pancreatic adverse events (AEs) are rare occurrences that are poorly documented in the literature.</p><p><strong>Research design and methods: </strong>We conducted a retrospective review of patients who had ICI up to June 2023. Patient follow-up was extended until death or to May 2024. The primary outcome was the incidence of severe ICI-related pancreatic AEs. Logistic regression was used to investigate the associations between clinical characteristics and severe ICI-related pancreatic AEs.</p><p><strong>Results: </strong>The study included 7,840 participants who received ICI. The study population was predominantly male (74.50%), with a median age of 59.20 years [IQR 51.90-67.70 years]. Among them, 49 patients (0.63%) developed severe ICI-related pancreatic AEs. Logistic regression revealed that pancreatic cancer (OR 5.47; [95% CI, 1.12-26.82], <i>p</i> = 0.036), lung cancer (OR 2.62; [95% CI, 1.09-6.34], <i>p</i> = 0.032), younger patients (OR 0.97; [95% CI, 0.94-0.99], <i>p</i> = 0.015), and using PD-L1 inhibitor (OR 3.09, [95% CI 1.46 to 6.52], <i>p</i> = 0.003) were associated with a higher risk of severe ICI-related pancreatic AEs.</p><p><strong>Conclusions: </strong>This study demonstrated that most ICI-related pancreatic AEs were asymptomatic. Primary tumor type, age, and ICI type may be predictive factors for severe ICI-related pancreatic AEs.</p><p><strong>Clinical trial registration: </strong>https://www.chictr.org.cn identifier is ChiCTR2300075974.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-6"},"PeriodicalIF":3.0,"publicationDate":"2025-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143974056","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":"Retrospective analysis of clinical features of liver injury induced by levofloxacin.","authors":"Zhaoquan Wu, Wei Sun, Chunjiang Wang","doi":"10.1080/14740338.2025.2494685","DOIUrl":"https://doi.org/10.1080/14740338.2025.2494685","url":null,"abstract":"<p><strong>Background: </strong>Current understanding of the relationship between levofloxacin exposure and hepatic injury primarily relies on case reports. This article aims to investigate the features of levofloxacin-induced liver injury.</p><p><strong>Research design and methods: </strong>We incorporated case series and reports regarding levofloxacin-induced hepatotoxicity published prior to 30 June 2024, utilizing an extensive search database. The data from 40 patients were collected and subjected to descriptive analysis.</p><p><strong>Results: </strong>The median age of the 40 patients was 60 years (range 10, 99), and the median time to exacerbation was 5 days (range 1 199). Liver injury was categorized as hepatocellular (62.5%), cholestatic (12.5%), and mixed (25.0%). Clinical manifestations included asymptomatic elevations in liver enzymes, jaundice, dark urine, nausea, vomiting, anorexia, hepatic encephalopathy. Laboratory evaluations revealed varying degrees of elevation in aminotransferases and total bilirubin. Biopsy results indicated hepatic necrosis, cholestasis, steatosis, and inflammatory infiltrates. After levofloxacin discontinuation, the median time to normalization of liver function was 21 days (range 3, 103), and 8 patients ultimately succumbing to the condition.</p><p><strong>Conclusions: </strong>Hepatotoxicity is an uncommon but severe adverse effect associated with levofloxacin. Immediate discontinuation of levofloxacin is warranted if there is a rapid increase in aminotransferase levels or the emergence of hepatitis symptoms.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-7"},"PeriodicalIF":3.0,"publicationDate":"2025-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143999719","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}
Henan Qin, Yibin Teng, Peiyao Yu, Zhen Ning, Jiwei Liu
{"title":"Cardiovascular adverse events associated with EGFR and HER2 dual TKIs: a pharmacovigilance study based on the FAERS database.","authors":"Henan Qin, Yibin Teng, Peiyao Yu, Zhen Ning, Jiwei Liu","doi":"10.1080/14740338.2025.2489529","DOIUrl":"10.1080/14740338.2025.2489529","url":null,"abstract":"<p><strong>Background: </strong>EGFR and HER2 dual TKIs have been approved for the treatment of advanced breast cancer in patients who are HER2-positive for second and/or third-line treatment. However, there is a lack of attention to the cardiovascular adverse events (AEs) caused by EGFR and HER2 dual TKIs.</p><p><strong>Research design and methods: </strong>We analyzed data spanning between March 2007 and June 2024 using the FAERS database and the reporting odds ratio, proportional reporting ratio, and Bayesian confidence propagation neural network to perform disproportionality analysis.</p><p><strong>Results: </strong>Compared with non-cardiovascular AEs, cardiovascular AEs were associated with more severe clinical outcomes, such as higher rates of hospitalization, life-threatening events, disability, and death. Our analysis revealed that lapatinib had a higher-than-expected reporting rate for three SMQs, including cardiac failure, embolic and thrombotic events, and cardiomyopathy. No significant cardiovascular signals were observed for neratinib.</p><p><strong>Conclusion: </strong>Disproportionality analysis results revealed a positive signal for cardiac failure, embolic and thrombotic events, and cardiomyopathy of lapatinib, and no positive signal for neratinib. We should pay attention to high-risk signals in clinical practice and monitor them appropriately.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-9"},"PeriodicalIF":3.0,"publicationDate":"2025-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143803009","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":"Does the use of generative AI chatbots by patients introduce risk of adverse drug events?","authors":"Roger S McIntyre","doi":"10.1080/14740338.2025.2493351","DOIUrl":"https://doi.org/10.1080/14740338.2025.2493351","url":null,"abstract":"","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-3"},"PeriodicalIF":3.0,"publicationDate":"2025-04-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143980410","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}
Praneeth Kudaravalli, Michael B Andrews, Douglas G Adler
{"title":"Comprehensive analysis of adverse drug reactions associated with teduglutide: post-marketing insights and safety implications.","authors":"Praneeth Kudaravalli, Michael B Andrews, Douglas G Adler","doi":"10.1080/14740338.2025.2493355","DOIUrl":"https://doi.org/10.1080/14740338.2025.2493355","url":null,"abstract":"<p><strong>Background: </strong>Intestinal failure often necessitates teduglutide, a glucagon-like peptide-2 (GLP-2) analog that enhances intestinal adaptation by increasing absorptive surface area, thereby reducing reliance on intravenous supplementation (IVS). This study analyzes adverse drug reactions (ADRs) associated with teduglutide when used to treat short bowel syndrome (SBS) to inform clinical practice and enhance post-marketing surveillance.</p><p><strong>Research design and methods: </strong>Retrospective analysis was conducted using the FDA Adverse Event Reporting System (FAERS) database. ADRs reported from teduglutide's FDA approval in 2012 through 20 August 2024 were analyzed using descriptive statistics and presented as [N (%)] or [median (IQR)].</p><p><strong>Results: </strong>Of the 4,533 reports, 2,669 were females, and patients had a median age of 56 years, with 2,787 reports involving hospitalization and 443 associated with death. Gastrointestinal ADRs were the most frequently reported (<i>N</i> = 3,881), followed by infections (<i>N</i> = 2,273), cardiovascular events (<i>N</i> = 1,318), weight changes (<i>N</i> = 754), neuropsychiatric concerns (<i>N</i> = 651), and device-related infections (<i>N</i> = 618) were prominent. Mortality associated ADRs included infections (<i>N</i> = 222), gastrointestinal events (<i>N</i> = 172), and cardiovascular complications (<i>N</i> = 132).</p><p><strong>Conclusions: </strong>Teduglutide is associated with significant ADRs necessitating vigilant monitoring while managing SBS patients, particularly for gastrointestinal health and infection risks. FAERS data limitations restrict causality determination, highlighting the need for further research to optimize safety.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-6"},"PeriodicalIF":3.0,"publicationDate":"2025-04-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144005114","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":"Ophthalmotoxicity induced by antibody-drug conjugates: a pharmacovigilance study of the FDA adverse event reporting system (FAERS).","authors":"Wenxia Zhao, Xin Feng, Shan Yang, Guosen Yuan, Min Huang, LinXiaoxiao Ding, Zhichao He, Junyan Wu","doi":"10.1080/14740338.2025.2491125","DOIUrl":"10.1080/14740338.2025.2491125","url":null,"abstract":"<p><strong>Background: </strong>Antibody-drug conjugates (ADCs) have demonstrated remarkable therapeutic efficacy in refractory cancers, however, ophthalmotoxicity remains a serious concern. This study aimed to investigate the association between ADCs and ophthalmotoxicity.</p><p><strong>Research design and methods: </strong>A retrospective pharmacovigilance study was conducted utilizing data extracted from the U.S. Food and Drug Administration Adverse Events Reporting System (FAERS) from 2004 to 2023. Disproportionality analyses were performed using the reporting odds ratio (ROR) and information component (IC), with sensitivity analyses and subgroup evaluations by age and sex.</p><p><strong>Results: </strong>A total of 1992 cases of ophthalmotoxicity linked to ADCs were identified, with a median latency of 40 days. The correlation between ophthalmotoxicity and ADCs was higher than with other medications (IC = 0.67, 95% CI:0.64-0.70). Signal detection revealed 36 adverse events unreported in product labeling. Sensitivity analyses confirmed the robustness of our results on the association between ADCs and ocular toxicity, with higher reporting in females compared to males (OR = 1.25, 95% CI: 1.11-1.40).</p><p><strong>Conclusions: </strong>ADCs had different profiles of ophthalmotoxicity. Our pharmacovigilance study suggested increased reporting of ophthalmotoxicity associated with ADCs.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-11"},"PeriodicalIF":3.0,"publicationDate":"2025-04-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143810818","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":"Pharmacovigilance study and genetic target prediction analysis of FDA adverse event reports (FAERS) for drug-induced sinusitis.","authors":"Enze Wang, Yingxuan Sun, He Zhao, Zhiwei Cao","doi":"10.1080/14740338.2025.2484474","DOIUrl":"10.1080/14740338.2025.2484474","url":null,"abstract":"<p><strong>Background: </strong>Drug-induced sinusitis has been widely reported as an adverse drug reaction in recent years, yet the pharmacogenetic mechanisms and risk factors associated with sinusitis remain elusive.</p><p><strong>Objective: </strong>We aimed to identify the major drugs reported in the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) in relation to sinusitis and to analyze their pharmacogenetic mechanisms through drug target analysis.</p><p><strong>Methods: </strong>We conducted a review of the publicly available FAERS database from 2004 to the third quarter of 2023. We extracted genetic tools corresponding to each drug, utilized colocalization analysis, Mendelian randomization (MR) analysis, and cross-tissue drug target analysis to predict the impact of drug targets on sinusitis.</p><p><strong>Results: </strong>Following the validation of drug-related risks, a total of 13 medications were ultimately identified, including TNF inhibitors: pomalidomide (ROR: 14.77), certolizumab pegol(ROR: 8.21), etanercept (ROR: 7.961), lenalidomide (ROR: 6.998), adalimumab (ROR: 6.677), infliximab (ROR: 3.939); C4B-targeted drugs: human immunoglobulin G (ROR:3.846) and other risk drugs were commonly reported. Co-localization analysis and MR analysis suggests associations between TNF, C4B, and LTA and sinusitis.</p><p><strong>Conclusion: </strong>We demonstrated the risk of sinusitis associated with 13 drugs, including pomalidomide, and the impact of TNF and C4B drugs on sinusitis, which provides guidance for the use of related drugs and the prevention of sinusitis.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-9"},"PeriodicalIF":3.0,"publicationDate":"2025-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143699638","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":"A real-world pharmacovigilance case/non-case study of FDA adverse event reporting system events for mannitol.","authors":"Zhi Jin, Yu Liu, Zongren Zhao","doi":"10.1080/14740338.2025.2492742","DOIUrl":"https://doi.org/10.1080/14740338.2025.2492742","url":null,"abstract":"<p><strong>Background: </strong>Mannitol, an osmotic diuretic, is widely used to treat edema, intracranial hypertension, and cerebral edema. This study analyzed mannitol-related adverse events (AEs) using the FDA adverse event reporting system (FAERS) data to identify potential safety signals.</p><p><strong>Research design and methods: </strong>A retrospective pharmacovigilance study was conducted using FAERS data from Q1 2013 to Q4 2023. Signal detection algorithms, including the reporting odds ratio (ROR) and proportional reporting ratio (PRR), were employed to identify and evaluate mannitol-related AEs. The analysis focused on the frequency, severity, and clinical relevance of reported AEs.</p><p><strong>Results: </strong>Among 39,061,894 reports, 1,014 mentioned mannitol. Common AEs included increased intracranial pressure, hyperosmolar state, hyperchloremia, and hypernatremia. 80% of AEs fell under 'renal and urinary disorders' (295 cases), 'skin and subcutaneous tissue disorders' (371 cases). Specific preferred terms (PTs) linked with mannitol included 'hyperosmolar state', (ROR = 665.98 (95% CI: 272.28-1628.95), PRR = 664.53 (95% CI: 269.75-1637.1)), 'hyperchloremia,' 'hypernatremia' (ROR = 25.18 (95% CI: 17.66-35.9), PRR = 24.85 (95% CI: 17.46-35.36)).</p><p><strong>Conclusions: </strong>This study underscores the need for vigilant monitoring of mannitol use. Further research is required to understand the mechanisms behind unexpected AEs and establish a comprehensive safety profile.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-8"},"PeriodicalIF":3.0,"publicationDate":"2025-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143974600","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":"Adverse events associated with obeticholic acid: a real-world, pharmacovigilance study.","authors":"Chunxia Zhang, Jianguo Wang","doi":"10.1080/14740338.2025.2487144","DOIUrl":"10.1080/14740338.2025.2487144","url":null,"abstract":"<p><strong>Background: </strong>Primary biliary cholangitis (PBC) is a chronic autoimmune liver disease predominantly affecting middle-aged women. While ursodeoxycholic acid (UDCA) is the first-line treatment, 30-40% of patients do not respond adequately, necessitating alternative therapies like Obeticholic Acid (OCA), an FXR agonist. The long-term safety of OCA remains insufficiently studied.</p><p><strong>Research design and methods: </strong>This study utilized the US FDA Adverse Event Reporting System (FAERS) to evaluate OCA safety through large-scale data mining, using disproportionality analyses (ROR, PRR, BCPNN, and MGPS) to identify adverse event signals.</p><p><strong>Results: </strong>From Q2 2016 to Q1 2024, 5,864 reports linked to OCA usage were identified among 13,245,871 AE reports. Significant signals across 27 System Organ Classes were found, with pruritus (12.54%), fatigue (4.16%), and nausea (1.64%) being the most prevalent adverse events. Severe hepatic events like liver failure were rare (0.6%). Median time to onset of AEs was 178 days. The most common outcomes reported were important medical events (18.6%), hospitalization (17.8%), and death (6.5%).</p><p><strong>Conclusion: </strong>This study provides key insights into the safety profile of OCA, highlighting the importance of monitoring for pruritus and hepatic complications, particularly within the first six months of treatment.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-9"},"PeriodicalIF":3.0,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143751681","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}