BMC Pharmacology & Toxicology最新文献

{"title":"Safety analysis of romiplostim, eltrombopag, and avatrombopag post-market approval: a pharmacovigilance study based on the FDA Adverse Event Reporting System.","authors":"Xiaoling Wang, Yunsong Li, Wei Zhuang","doi":"10.1186/s40360-025-00873-8","DOIUrl":"10.1186/s40360-025-00873-8","url":null,"abstract":"<p><strong>Background: </strong>Romiplostim, eltrombopag, and avatrombopag, as new-generation thrombopoietin receptor agonists (TPO-RAs), have been widely used in the treatment of immune thrombocytopenia (ITP). Given their similar efficacy, a comprehensive evaluation of their safety is crucial for optimizing treatment choices. This study aims to explore the potential safety issues of three major drugs for treating ITP: romiplostim, eltrombopag, and avatrombopag, thereby providing references and research directions for subsequent high-quality clinical studies.</p><p><strong>Methods: </strong>We retrieved data from the FDA Adverse Event Reporting System (FAERS) database from the first quarter of 2018 to the second quarter of 2023. Using reporting odds ratio (ROR), proportional reporting ratio (PRR), bayesian confidence propagation neural network (BCPNN), and multiple gamma poisson shrinkage (MGPS), we mined and analyzed adverse events (AEs) associated with romiplostim, eltrombopag, and avatrombopag. The Designated Medical Event (DME) list from the European Medicines Agency (EMA) was used to screen out the DME of three drugs. Venn analysis was used to screen the specific AEs of each drug.</p><p><strong>Results: </strong>The study included 2,851 cases of romiplostim, 10,297 cases of eltrombopag, and 973 cases of avatrombopag. Venn analysis revealed nine common AEs across the three drugs. The number of significant specific AEs associated with romiplostim, eltrombopag, and avatrombopag were 58, 98, and 15 respectively. DMEs for romiplostim included autoimmune haemolytic anaemia (ROR = 6.1, n = 3), haemolytic anaemia (ROR = 8.13, n = 7), sudden hearing loss (ROR = 5.24, n = 3), haemolysis (ROR = 3.89, n = 3). DMEs for eltrombopag included hepatic infection (ROR = 9.56, n = 6), granulocytopenia (ROR = 2.91, n = 4), autoimmune haemolytic anaemia (ROR = 3.03, n = 5), haemolytic anaemia (ROR = 3.46, n = 10), haemolysis (ROR = 4.65, n = 12), hepatic failure (ROR = 2.51, n = 23). Not a single DME was found for avatrombopag.</p><p><strong>Conclusion: </strong>This study indicates that eltrombopag manifests significant safety signals within the hepatic system. This implies that monitoring liver function during treatment is advisable. Avatrombopag shows relatively lower hepatotoxicity signals; however, further large-scale studies are needed to validate these observations. Moreover, both romiplostim and eltrombopag therapies may be linked to a risk of sudden hearing loss or deafness, which merits clinical attention. These findings offer crucial safety references for clinical drug use. Nevertheless, the causal relationship between the drugs and AEs necessitates further in-depth investigation.</p>","PeriodicalId":9023,"journal":{"name":"BMC Pharmacology & Toxicology","volume":"26 1","pages":"46"},"PeriodicalIF":2.8,"publicationDate":"2025-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11869546/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143522685","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development and validation of a nomogram to predict linezolid-induced thrombocytopenia in hospitalized adults.","authors":"Ya Yang, Xiaogang Hu, Ya Ran, Hongqian Wang, Peishu Fu, Pengpeng Wan, Zhongqing Deng, Xiaoqin Lang, Ning Wang, Fengjun Sun, Yahan Fan, Yuntao Jia","doi":"10.1186/s40360-025-00874-7","DOIUrl":"10.1186/s40360-025-00874-7","url":null,"abstract":"<p><strong>Background: </strong>Linezolid (LZD) is used to treat infectious diseases caused by Gram-positive bacteria, but thrombocytopenia is one of the main adverse reactions to LZD administration. Early prediction of linezolid-induced thrombocytopenia (LI-TP) is of great importance to improve the clinical outcomes and prognoses. The aim of this study was to develop and validate a prediction model for LI-TP.</p><p><strong>Methods: </strong>A retrospective cohort of hospitalized adults receiving LZD therapy (January 2014-June 2022) was analyzed. Independent risk factors for LI-TP were identified via logistic regression in the training set (n = 757). A nomogram model for LI-TP were developed based on independent risk factors, and verified in validation set (n = 123).</p><p><strong>Results: </strong>The incidence of LI-TP was 13.5% (102/757). A logistic regression model was developed based on the seven independent risk factors, including age (≥ 60 y), duration of LZD therapy (> 11 d), bPLT (< 308 × 10⁹/L), ALT (> 100 IU/L), Ccr (< 67.5 mL/min), and concomitant use with VPA or Tac (p < 0.01) and transformed into a quantifiable nomogram. The nomogram demonstrated strong discrimination with AUCs of 0.760 in training (95% CI: 0.709-0.812, P < 0.001) and 0.767 in validation (95% CI: 0.635-0.899, P < 0.001). The calibration curves and Hosmer-Lemeshow tests confirmed good reliability and specificity of the nomogram model.</p><p><strong>Conclusion: </strong>This nomogram provides a practical tool for stratifying LI-TP risk, which provide an important reference for enabling timely clinical interventions to enhance LZD safety.</p>","PeriodicalId":9023,"journal":{"name":"BMC Pharmacology & Toxicology","volume":"26 1","pages":"47"},"PeriodicalIF":2.8,"publicationDate":"2025-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11869706/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143522593","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Past use of metformin is associated with increased risk of myelodysplastic syndrome development in diabetes mellitus patients: a cross-sectional study of 54,869 patients.","authors":"Tamer Hellou, Guy Dumanis, Shir Portugez, Aviv Philip Goncharov, Eden Trodler, Asaf Stern, Imanuel Carlebach, Omer Kahlon, Maysan Abu Jwella, Ekram Nimer, Ahlam Athamna, Aya Berman, Gad Segal, Reut Kassif Lerner","doi":"10.1186/s40360-025-00882-7","DOIUrl":"10.1186/s40360-025-00882-7","url":null,"abstract":"<p><strong>Background: </strong>Myelodysplastic Syndrome (MDS) is a devastating hematologic malignancy associated with advanced age. Diabetes Mellitus (DM) is one of the most common morbidities worldwide, with metformin serving as the first line therapy for several decades. However, the potential association between previous metformin use and the risk of developing MDS remains uncertain.</p><p><strong>Methods: </strong>This cross-sectional study addressed the possible association between prior metformin use in DM patients and the subsequent development of MDS.</p><p><strong>Results: </strong>Data from 54,869 DM patients was retrieved from their medical records from a tertiary medical center. Of these, 20,318 patients had been exposed at some point in time to metformin, with 133 (0.7%) subsequently developing MDS. In contrast, among 34,551 DM patients with no prior exposure to metformin, only 154 (0.4%) developed MDS later in life. The Odds Ratio (OR) for MDS development amongst metformin users compared to the entire study population was 1.48 (95% CI 1.17-1.86; p = 0.001). A multivariate analysis adjusting for gender, age, congestive heart failure and chronic kidney disease, past exposure to metformin remained an independent risk factor for MDS development (OR = 1.6, 95% CI 1.26-2.03; p < 0.001).</p><p><strong>Conclusion: </strong>Previous exposure to metformin amongst DM patients is associated with an increased risk for MDS development later in life. This is a preliminary, cross-sectional study that show that larger studies in variable MDS patient populations are warranted.</p>","PeriodicalId":9023,"journal":{"name":"BMC Pharmacology & Toxicology","volume":"26 1","pages":"45"},"PeriodicalIF":2.8,"publicationDate":"2025-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11869568/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143522684","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Haemorrhage-related adverse events profles of lenvatinib and pembrolizumab alone or in combination: a real-world pharmacovigilance study based on FAERS database.","authors":"Shiqiao Wang, Guizhi Ren, Heng Pan, Jiayi Chen, Jiayu Huang, Qinghua Mei, Zhongze Li, Guosheng Zou","doi":"10.1186/s40360-025-00878-3","DOIUrl":"10.1186/s40360-025-00878-3","url":null,"abstract":"<p><strong>Objective: </strong>Limited understanding exists regarding the haemorrhagic risk resulting from potential interactions between lenvatinib and pembrolizumab. We investigated haemorrhagic adverse events (ADEs) associated with co-administration of lenvatinib and pembrolizumab using data from the Food and Drug Administration Adverse Event Reporting System (FAERS) in an effort to provide recommendations for their safe and sensible use.</p><p><strong>Methods: </strong>The FAERS database's bleeding events linked to lenvatinib and pembrolizumab were carefully examined. Haemorrhagic signals mining was performed by the reported odds ratios (RORs) and information component (IC), corroborated by additive and multiplicative models.</p><p><strong>Results: </strong>A total of 38,416,055 adverse event cases were analyzed, with 1188 bleeding events records in the lenvatinib alone, 952 bleeding events records in the pembrolizumab alone and 420 bleeding events reports in the combination therapy, respectively. We observed a significantly higher risk of haemorrhage with the combination of lenvatinib and pembrolizumab compare with pembrolizumab alone. In addition, in the baseline model analysis of suspected bleeding adverse reactions, the additive model detected an increased incidence of small intestinal haemorrhage caused by combination therapy, and found no risk signals of tumour haemorrhage and tracheal haemorrhage; the results of multiplicative model are all negative.</p><p><strong>Conclusion: </strong>The analysis of FAERS data reveals different levels of haemorrhagic risk when lenvatinib and pembrolizumab are administered concurrently, highlighting the significance of being cautious when using them in clinical practice.</p>","PeriodicalId":9023,"journal":{"name":"BMC Pharmacology & Toxicology","volume":"26 1","pages":"44"},"PeriodicalIF":2.8,"publicationDate":"2025-02-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11863795/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143498887","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real world results of ibrutinib in patients with relapsed or refractory chronic lymphocytic leukemia: a meta-analysis of clinical studies.","authors":"Mohammad Amin Karimi, Hanieh Norooziseyedhosseini, Reza Khademi, Alireza Ghajary, Haniyeh Kargar, Seyyedeh Sana Abdollahi, Mohaddeseh Belbasi, Mahdyieh Naziri, Niloofar Deravi, Sajjad Hajihosseini, Saharnaz Mofidi","doi":"10.1186/s40360-024-00832-9","DOIUrl":"10.1186/s40360-024-00832-9","url":null,"abstract":"<p><strong>Background: </strong>Chronic lymphocytic leukemia (CLL) is a B-cell malignancy primarily diagnosed in older adults. For younger patients, treatment options often include regimens based on fludarabine, cyclophosphamide, and rituximab; however, at least 20% of patients exhibit resistance to these therapies. Ibrutinib, a covalent Bruton's tyrosine kinase (BTK) inhibitor, has demonstrated enhanced safety compared to conventional treatments. This meta-analysis examines the efficacy and safety of ibrutinib in managing relapsed/refractory CLL.</p><p><strong>Method: </strong>Relevant keywords were used to conduct a comprehensive search across online databases, including PubMed, Scopus, and Google Scholar. Data related to complete response (CR), overall response rate (ORR), and adverse events were extracted to evaluate the efficacy and safety of ibrutinib treatment. The results were presented in forest plots illustrating event rates and risk ratios with 95% confidence intervals (CI), while heterogeneity was assessed using I² statistics. Funnel plots were employed to examine potential publication bias visually.</p><p><strong>Result: </strong>Twenty-one studies were included in this meta-analysis. Ibrutinib as a single-agent treatment was associated with a 9% complete response (CR) rate (95% CI: 5-14%) and a 77% overall response rate (ORR) (95% CI: 70-83%). When combined with other agents, ibrutinib achieved a CR rate of 21% (95% CI: 9-41%) and an ORR of 84% (95% CI: 80-88%). Adverse events were not significantly correlated with treatment outcomes. Funnel plots indicated no significant publication bias.</p><p><strong>Conclusion: </strong>Single-agent ibrutinib has proven to be an effective therapy for patients with relapsed/refractory CLL. However, combining ibrutinib with other agents has demonstrated enhanced treatment efficacy. Further studies are needed to evaluate the safety profile of this therapeutic regimen thoroughly.</p>","PeriodicalId":9023,"journal":{"name":"BMC Pharmacology & Toxicology","volume":"26 1","pages":"43"},"PeriodicalIF":2.8,"publicationDate":"2025-02-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11853497/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143498889","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correction: Effects of cypermethrin exposure on learning and memory functions and anxiety-like behavior in rats.","authors":"Mansour Nazari, Mohammadmahdi Sabahi, Arash Salehipour, Sara Ami Ahmadi, Azin Kazemi, Shahab Razipour, Nafiseh Faraji, Alireza Komaki","doi":"10.1186/s40360-025-00876-5","DOIUrl":"10.1186/s40360-025-00876-5","url":null,"abstract":"","PeriodicalId":9023,"journal":{"name":"BMC Pharmacology & Toxicology","volume":"26 1","pages":"42"},"PeriodicalIF":2.8,"publicationDate":"2025-02-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11863487/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143498789","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real-world safety analysis of deutetrabenazine post-marketing: a disproportionality study leveraging the FDA Adverse Event Reporting System (FAERS) database.","authors":"Guangwei Qing, Shiyi Ye, Bo Wei, Yuanjian Yang","doi":"10.1186/s40360-025-00872-9","DOIUrl":"10.1186/s40360-025-00872-9","url":null,"abstract":"<p><strong>Background: </strong>Deutetrabenazine, a selective vesicular monoamine transporter type 2 (VMAT2) inhibitor, has been demonstrated efficacy in treating refractory neurologic disorders such as Tardive Dyskinesia (TD) and Huntington's disease but have potential adverse events (AEs) that require detailed pharmacovigilance. This study aimed to comprehensively assess the safety profile of deutetrabenazine in real-world settings by analyzing AEs reported from the FDA Adverse Event Reporting System (FAERS) database.</p><p><strong>Methods: </strong>We conducted a retrospective pharmacovigilance study using FAERS data from Q3 2017 to Q3 2024, focusing on deutetrabenazine-related AEs. We applied four disproportionality analysis methods-Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN) and Multinomial Gamma Poisson Shrinkage (MGPS)--to identify potential safety signals. Furthermore, we utilized the Weibull distribution model to analyze the temporal risk of AEs.</p><p><strong>Results: </strong>Among the 10,571,578 reports obtained from the FAERS database, 4,337 AE reports were associated with deutetrabenazine. Using four independent computational methods at the preferred term (PT) level, we identified 1,131 PTs that indicated noteworthy adverse reactions. The drug's label-listed adverse reactions, including depression, somnolence, suicidal ideation, and fatigue, showed remarkable signals. Furthermore, we detected potential adverse reactions that were not specified on the label, such as drug ineffectiveness, dyskinesia, death, falls, and insomnia. The majority of these AEs were reported within the initial month of deutetrabenazine treatment, with a median time to onset of 40.5 days.</p><p><strong>Conclusion: </strong>This research has yielded initial safety insights into the practical use of deutetrabenazine, validating established adverse reactions and uncovering further possible risks. These findings present essential safety considerations for physicians when prescribing deutetrabenazine for the clinical treatment.</p>","PeriodicalId":9023,"journal":{"name":"BMC Pharmacology & Toxicology","volume":"26 1","pages":"41"},"PeriodicalIF":2.8,"publicationDate":"2025-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11846250/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143476219","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Neuroprotective effects of berberine in preclinical models of ischemic stroke: a systematic review.","authors":"Ghasem Dolatkhah Laein, Elahe Boumeri, Saghar Ghanbari, Amin Bagherian, Fatemeh Ahmadinasab, Vahid Poudineh, Shima Payandeh, Negar Rashidi","doi":"10.1186/s40360-025-00843-0","DOIUrl":"10.1186/s40360-025-00843-0","url":null,"abstract":"<p><strong>Background/objective: </strong>Berberine, a naturally occurring alkaloid, has shown promise as a neuroprotective agent in preclinical models of ischemic stroke. This systematic review aims to comprehensively evaluate the neuroprotective effects of berberine in animal models of cerebral ischemia and elucidate its potential mechanisms of action.</p><p><strong>Methods: </strong>A systematic search was conducted across nine databases, including PubMed, Embase, Cochrane CENTRAL, Web of Science, Scopus, ScienceDirect, Europe PMC, DOAJ, and Google Scholar, from inception to June 30, 2024. Controlled in vivo studies investigating the neuroprotective effects of berberine in animal models of focal cerebral ischemia were included. Two independent reviewers screened studies, extracted data, and assessed the risk of bias using the SYRCLE tool.</p><p><strong>Results: </strong>Eighteen studies met the inclusion criteria, encompassing various animal models of ischemic stroke. Berberine treatment consistently resulted in significant reductions in infarct volume and improvements in neurological function compared to control groups. Specifically, berberine doses ranging from 10 mg/kg to 300 mg/kg significantly decreased infarct sizes (p < 0.05). Berberine also exhibited anti-inflammatory effects by reducing pro-inflammatory cytokines such as TNF-α, IL-1β, and IL-6, and downregulating the TLR4/NF-κB signaling pathway (p < 0.05). Antioxidant effects were evidenced by decreased malondialdehyde levels and increased antioxidant enzymes like superoxide dismutase and glutathione (p < 0.05). Additional findings from studies with smaller sample sizes indicated that berberine reduced apoptotic cell death by decreasing TUNEL-positive cells and modulating apoptosis-related proteins, including increasing Bcl-2 and decreasing cleaved caspase-3 levels (p < 0.05). Berberine also promoted neurogenesis and synaptic plasticity by increasing the expression of BDNF, TrkB, and synaptic proteins SYP and PSD95 (p < 0.05), and enhanced autophagic flux by modulating key autophagy markers (p < 0.05). The risk of bias varied among studies, with some lacking detailed reporting on randomization and blinding procedures.</p><p><strong>Conclusion: </strong>Berberine demonstrates significant neuroprotective effects in preclinical models of ischemic stroke through multiple mechanisms, including anti-inflammatory, antioxidant, anti-apoptotic, and neuroregenerative actions. These findings support the potential of berberine as a multifaceted therapeutic agent for ischemic stroke. Further well-designed clinical trials are warranted to confirm its efficacy and safety in human patients.</p>","PeriodicalId":9023,"journal":{"name":"BMC Pharmacology & Toxicology","volume":"26 1","pages":"40"},"PeriodicalIF":2.8,"publicationDate":"2025-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11844076/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143476218","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Risk factors for gastrointestinal complications during glucocorticoid therapy in internal medicine inpatients: a real-world retrospective analysis.","authors":"Pengpeng Liu, Guangyao Li, Qinglin Yang, Kai Cao, Jiawei Wang","doi":"10.1186/s40360-025-00871-w","DOIUrl":"10.1186/s40360-025-00871-w","url":null,"abstract":"<p><strong>Background: </strong>The risk factors for gastrointestinal complications during glucocorticoid therapy in internal medicine inpatients are rarely reported. This study aimed to investigate the risk factors for gastrointestinal complications in internal medicine patients using glucocorticoids.</p><p><strong>Methods: </strong>Internal medicine inpatients receiving glucocorticoid therapy from February 2023 to September 2023 were included. Gastrointestinal complications were identified by careful review of the electronic medical records of these patients. The risk factors for gastrointestinal complications during glucocorticoid therapy were analyzed by univariable and multivariable logistic regression. Receiver operating characteristic (ROC) curve with Youden's index was used to determine the best cutoff point of the identified continuous variables.</p><p><strong>Results: </strong>Of the 960 inpatients included, 88 had gastrointestinal complications, with the most common complications including 27 (30.7%) with abdominal discomfort, 26 (29.5%) with acid regurgitation and heartburn, and 14 (15.9%) with asymptomatic positive fecal occult blood. Multiple logistic regression analysis showed that age ≥ 65 years [OR = 2.014, 95% CI (1.096, 3.703), p = 0.024], history of gastroesophageal reflux disease (GERD) [OR = 1.810, 95% CI (1.009, 3.250), p = 0.047], history of peptic ulcer (PU) [OR = 5.636, 95% CI (1.505, 21.102), p = 0.010], maximum dose of glucocorticoids [OR = 1.003, 95% CI (1.001, 1.004), p = 0.001], and nonsteroidal anti-inflammatory drugs (NSAIDs) [OR = 2.788, 95% CI (1.023, 7.597), p = 0.045] were associated with more gastrointestinal complications during glucocorticoid therapy in internal medicine inpatients. ROC curve analysis revealed that when the maximum dose of glucocorticoids was greater than 160 mg, gastrointestinal complications were more likely to occur.</p><p><strong>Conclusions: </strong>The study shows that age ≥ 65 years, history of GERD, history of PU, maximum dose of glucocorticoids, and NSAIDs are associated with more gastrointestinal complications during glucocorticoid therapy in internal medicine inpatients. Multidisciplinary teams, including physicians, pharmacists, and nurses, should consider increased monitoring to inpatients with high-risk factors.</p>","PeriodicalId":9023,"journal":{"name":"BMC Pharmacology & Toxicology","volume":"26 1","pages":"37"},"PeriodicalIF":2.8,"publicationDate":"2025-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11841309/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143466788","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A pharmacovigilance study of olanzapine/samidorphan based on FDA Adverse Event Reporting System (FAERS).","authors":"Luyao He, Mengting Shen, Lei Zhang, Yan Li, Huafang Li","doi":"10.1186/s40360-025-00869-4","DOIUrl":"10.1186/s40360-025-00869-4","url":null,"abstract":"<p><strong>Objects: </strong>The olanzapine/samidorphan (OLZ/SAM) combination is being regarded as a new strategy to combat weight gain induced by olanzapine (OLZ), and its safety is of significant concern. Specifically, as samidorphan is an opioid receptor-related drug, issues related to its potential for dependence and withdrawal symptoms deserve attention. This study aims to provide a comprehensive analysis of adverse events (AEs) associated with the OLZ/SAM.</p><p><strong>Methods: </strong>This study is a pharmacovigilance study based on the analysis of reports from the FDA Adverse Event Reporting System (FAERS) utilizing the Openvigil online analysis platform for the period from January 1, 2023, to June 30, 2024. Signal results were reported as Reporting Odds Ratios (ROR) along with 95% confidence intervals. A binary logistic regression model was used to analyze the association between the OLZ/SAM and specific AEs.</p><p><strong>Results: </strong>This study included 86 reports of AEs associated with the OLZ/SAM and 4,678 reports related to OLZ. In terms of frequency of OLZ/SAM-related AEs, off-label use (N = 12) and drug withdrawal syndrome (N = 11) were reported most frequently. Among various system organ classes, the highest frequency of AEs was observed in neurological disorders (SOC) (N = 23). We identified 15 signals associated with the OLZ/SAM. The results of the stepwise regression analysis indicated that in all models, the OLZ/SAM was significantly associated with drug withdrawal syndrome when compared to OLZ (p < 0.01).</p><p><strong>Conclusion: </strong>The long-term safety of the OLZ/SAM warrants attention, particularly concerning drug withdrawal syndrome.</p>","PeriodicalId":9023,"journal":{"name":"BMC Pharmacology & Toxicology","volume":"26 1","pages":"39"},"PeriodicalIF":2.8,"publicationDate":"2025-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11843756/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143466781","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}