Expert Opinion on Drug Safety最新文献

Hepatic adverse events associated with anaplastic lymphoma kinase tyrosine kinase inhibitors: a disproportionality analysis based on FAERS database and analysis of drug-gene interaction network. 肝不良事件与间变性淋巴瘤激酶酪氨酸激酶抑制剂相关：基于FAERS数据库和药物-基因相互作用网络分析的歧化分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-09-01 Epub Date: 2025-02-18 DOI: 10.1080/14740338.2025.2467830

Yan Huo, Minghua Ma, Weiwei Tian, Fang Wang, Xiaolan Liao

{"title":"Hepatic adverse events associated with anaplastic lymphoma kinase tyrosine kinase inhibitors: a disproportionality analysis based on FAERS database and analysis of drug-gene interaction network.","authors":"Yan Huo, Minghua Ma, Weiwei Tian, Fang Wang, Xiaolan Liao","doi":"10.1080/14740338.2025.2467830","DOIUrl":"10.1080/14740338.2025.2467830","url":null,"abstract":"Background: Anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitors (TKIs) are vital for treating ALK-positive cancers but have been associated with liver injury, necessitating further safety investigation. This study examines hepatic adverse event (AE) signals related to ALK TKIs using the U.S. FDA Adverse Event Reporting System (FAERS) and explores potential mechanisms of liver injury.Research design and methods: AE reports from FAERS (Q3 2011 to Q1 2024) related to liver injury were analyzed using the reporting odds ratio (ROR) and multi-item gamma Poisson shrinker (MGPS) methods. Pathway enrichment and drug-gene network analyses were performed to investigate underlying mechanisms.Results: This study identified 2,132 AE reports from the FAERS database linking hepatic AEs to ALK TKIs therapy. Significant signals were detected by ROR and MGPS methods, with common AEs including aminotransferase abnormalities, hyperbilirubinemia, and increased blood alkaline phosphatase, mainly occurring within the first 30 days of treatment. Gene analysis revealed key nodes in the protein-protein interaction (PPI) network, such as PIK3CA, SRC, and PTK2. Enriched KEGG pathways included the MAPK, PI3K-Akt, and Ras signaling.Conclusion: This pharmacovigilance study identifies significant AE signals linking ALK TKIs to liver injury, highlighting potential mechanisms and providing insights for clinical management and patient outcomes.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1661-1671"},"PeriodicalIF":3.0,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143413753","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}

引用次数: 0

GLP-1 receptor agonists in older people with type 2 diabetes: safety evidence from the real world. GLP-1受体激动剂在老年2型糖尿病患者中的应用：来自现实世界的安全性证据

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-09-01 Epub Date: 2026-03-04 DOI: 10.1080/14740338.2026.2640982

Marella Marassi, Gian Paolo Fadini

{"title":"GLP-1 receptor agonists in older people with type 2 diabetes: safety evidence from the real world.","authors":"Marella Marassi, Gian Paolo Fadini","doi":"10.1080/14740338.2026.2640982","DOIUrl":"10.1080/14740338.2026.2640982","url":null,"abstract":"Introduction: GLP-1 receptor agonists (GLP-1RA) are glucose- and body weight-lowering therapies provided with cardio-renal benefits. Use of GLP-1RA in older adults with type 2 diabetes mellitus (T2DM) is increasing but concerns remain about their safety in this age group, particularly in light of multimorbidity, frailty, and polypharmacy, as well as age-related vulnerability to adverse events (AEs).Areas covered: We discuss the opportunities and challenges of GLP-1RA in older people with T2DM, focusing on real-world (RW) safety evidence. Available RW studies confirm the established GLP-1RA safety profile, with AEs in 10-30% of older users, predominantly gastrointestinal and mild-to-moderate in severity. Age-stratified analyses provide mixed results on AE susceptibility, but discontinuation due to intolerance appears more frequent in older adults. Weight loss is preserved across age groups, with no consistent evidence of harmful unintended reductions. However, the effects on muscle mass and sarcopenia risk remain largely unexplored.Expert opinion: Current RW evidence supports GLP-1RA as a safe therapeutic option for older individuals with T2DM, without age-specific safety signals. Clinical phenotype-driven selection is essential to balance benefits and risks, particularly regarding nutritional status and frailty. Prospective, phenotype-stratified studies with body composition assessment are needed to guide optimal, individualized use in aging populations.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1623-1627"},"PeriodicalIF":3.0,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147343926","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}

引用次数: 0

Hepatic adverse events with CDK4/6 inhibitors: a systematic review combining meta-analysis and FAERS database. CDK4/6抑制剂的肝脏不良事件：一项结合meta分析和FAERS数据库的系统综述。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-09-01 Epub Date: 2025-02-23 DOI: 10.1080/14740338.2025.2468357

Yuyao Tang, Yongxin Li, Chengrong Zhang, Yinyin Ye, Tianlei Qiu, Zijun Zhu, Jiuda Zhao

{"title":"Hepatic adverse events with CDK4/6 inhibitors: a systematic review combining meta-analysis and FAERS database.","authors":"Yuyao Tang, Yongxin Li, Chengrong Zhang, Yinyin Ye, Tianlei Qiu, Zijun Zhu, Jiuda Zhao","doi":"10.1080/14740338.2025.2468357","DOIUrl":"10.1080/14740338.2025.2468357","url":null,"abstract":"Background: Cell-cycle protein-dependent kinase 4 and 6 inhibitors (CDK4/6is) in combination with endocrine therapy (ET) are widely used in patients with early and advanced breast cancer (BC). CDK4/6is also lead to numerous side effects. This study aims to elucidate the relationship between CDK4/6is and hepatotoxicities.Research design and methods: As of 31 March 2024, we conducted a systematic search of PubMed, Embase, and the Cochrane Library databases, as well as several oncology conference proceedings. We included 20 randomized controlled trials (RCTs) with 24,342 breast cancer (BC) patients and 400 cases from the FDA Adverse Event Reporting System (FAERS). Fixed-effect and random-effect models were used to calculate odds ratios (ORs) of hepatotoxicity in the RCTs, while Reporting Odds Ratios (RORs) were calculated for the FAERS data.Results: Overall, CDK4/6 inhibitors (CDK4/6is) were associated with significant hepatotoxicities compared to controls (OR = 1.76, 95%CI 1.40-2.22, I2 = 75%). Palbociclib, ribociclib, and abemaciclib exhibited significant hepatotoxicities, while dalpiciclib did not. FAERS data showed significant liver enzyme and organ toxicity signals for ribociclib and abemaciclib but not for palbociclib.Conclusions: CDK4/6is increase the risk of hepatotoxicities in patients with BC. Palbociclib, ribociclib, and abemaciclib caused liver damage, while dalpiciclib did not. The most common manifestations were elevated ALT and AST levels.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1641-1651"},"PeriodicalIF":3.0,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143440395","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}

引用次数: 0

Adverse events of concomitant use of immune checkpoint inhibitors and metformin or statin: an observational, retrospective disproportionality analysis. 同时使用免疫检查点抑制剂和二甲双胍或他汀类药物的不良事件：一项观察性、回顾性歧化分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-09-01 Epub Date: 2025-04-18 DOI: 10.1080/14740338.2025.2494684

Wenjie Li, Wei Wang

{"title":"Adverse events of concomitant use of immune checkpoint inhibitors and metformin or statin: an observational, retrospective disproportionality analysis.","authors":"Wenjie Li, Wei Wang","doi":"10.1080/14740338.2025.2494684","DOIUrl":"10.1080/14740338.2025.2494684","url":null,"abstract":"Background: Preclinical investigations have indicated that the concurrent administration of ICIs with statins or metformin may enhance the anticancer properties. Nevertheless, the patterns of potential toxicity associated with this combination have yet to be elucidated.Research design and methods: We utilized the Food and Drug Administration Adverse Event Reporting System (FAERS) to provide an overview of the adverse event landscape tied to the concomitant utilization of ICI and statins or metformin.Results: Our study reveals significant side effects associated with combining ICIs with metformin or statins, including gastrointestinal, respiratory, hepatobiliary, and renal disorders. Amalgamated treatment of ICIs plus metformin may heighten the likelihood of bone marrow aplasia, inflammatory bowel disease, intestinal perforation, hepatic impairments, insomnia, autoimmune nephritis, and eczematous manifestations. For ICIs plus statins, colitis, pneumonitis, interstitial lung disease, hypothyroidism, adrenal insufficiency, myocarditis, myositis, hypophysitis, myasthenia gravis, and hepatitis. Importantly, a significant number of adverse events occur within the first two months of starting ICIs alongside metformin or statins, with some appearing after a year of treatment, emphasizing the need for ongoing monitoring.Conclusion: The observations delineated offer pivotal insights into the refinement of the co-administration strategy for ICIs with metformin or statins, attenuating the incidence of adverse side effects.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1721-1730"},"PeriodicalIF":3.0,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143992957","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}

引用次数: 0

Are the current safety measures for the treatment of depression with esketamine sufficient? 目前艾氯胺酮治疗抑郁症的安全措施是否足够？

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-09-01 Epub Date: 2026-02-19 DOI: 10.1080/14740338.2026.2627184

Kyle Valentino, Kayla M Teopiz, Christine E Dri, Jennifer Swainson, Yang Jing Zheng, Roger S McIntyre

引用次数: 0

Safety of dual orexin receptor antagonists: a real-world pharmacovigilance study. 双重食欲素受体拮抗剂的安全性：一项真实世界的药物警戒研究。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-09-01 Epub Date: 2025-02-24 DOI: 10.1080/14740338.2025.2471520

Yu Sun, Tao Xu, Hongbin Xu

{"title":"Safety of dual orexin receptor antagonists: a real-world pharmacovigilance study.","authors":"Yu Sun, Tao Xu, Hongbin Xu","doi":"10.1080/14740338.2025.2471520","DOIUrl":"10.1080/14740338.2025.2471520","url":null,"abstract":"Background: Dual orexin receptor antagonists (DORAs) are widely used for treating insomnia. However, real-world data on the adverse events (AEs) induced by DORAs are lacking.Methods: Data related to daridorexant, suvorexant, and lemborexant were collected from the US Food and Drug Administration Adverse Event Reporting System between the first quarter of 2022 and the third quarter of 2024. Two established signal quantification methods, the reporting odds ratios and proportional reporting ratios, were applied.Results: A total of 2665 reports on daridorexant (1738, 65.22%), suvorexant (667, 25.03%), and lemborexant (260, 9.75%) were obtained. 24 targeted systems for daridorexant, 24 for suvorexant, and 25 for lemborexant were involved. We analyzed the top 30 preferred terms (PTs) that met both algorithm criteria and identified 69 PTs. The highest signal of strength of PT was sleep paralysis for daridorexant and lemborexant, and abnormal sleep-related event for suvorexant. The most frequent PT was somnolence for lemborexant (30, 11.54%) and insomnia for daridorexant (252, 14.50%) and suvorexant (62, 9.30%) within the top 30 PTs.Conclusion: The analysis of disproportionality signals may prompt increased awareness of toxicities for DORAs. The results of serious reports and dosage of drugs provided supporting evidence for clinicians to manage AEs.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1695-1701"},"PeriodicalIF":3.0,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143476156","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}

引用次数: 0

Drug-associated pancreatic cancer: insights from real-world pharmacovigilance and network pharmacology. 药物相关性胰腺癌：来自现实世界药物警戒和网络药理学的见解。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-09-01 Epub Date: 2025-03-06 DOI: 10.1080/14740338.2025.2469273

Hao Xie, Qiang Xu, Bin Zhao, Wenming Wu

{"title":"Drug-associated pancreatic cancer: insights from real-world pharmacovigilance and network pharmacology.","authors":"Hao Xie, Qiang Xu, Bin Zhao, Wenming Wu","doi":"10.1080/14740338.2025.2469273","DOIUrl":"10.1080/14740338.2025.2469273","url":null,"abstract":"Background: Pancreatic cancer's high mortality rate necessitates our study, which aims to identify potential risk drugs and speculate on the underlying mechanisms.Research design and methods: All pertinent reports from the FDA Adverse Event Reporting System database were extracted. The disproportionality analysis was used in signal detection and data on patient age, sex, weight, time to onset were collected. Seven databases were retrieved for network pharmacology. AutoDock Vina 1.1.2 was for molecular docking.Results: Signals were detected among 397 drugs with pancreatic cancer report ≥3. Except 4 antineoplastic agents, only 24 drugs indicated pancreatic cancer signals in 33,948 reports including 4 dipeptidyl peptidase-4 (DPP-4) inhibitors, 3 glucagon-like peptide-1 (GLP-1) analogues, 5 compound hypoglycemic agents, 3 hypotensive agents, ranitidine, pancrelipase, fondaparinux, naldemedine, daprodustat, megestrol acetate, leuprorelin, lecanemab, and lorcaserin. Pancreatic cancer more occurred after the age of 45, with a higher proportion among male. Weight with GLP-1 analogues (median, 91 kg), and compound hypoglycemic agents (median, 82 kg) was heavier (p < 0.01). GLP1R (glucagon-like peptide 1 receptor) for GLP-1 analogues, and PTEN (phosphatase and tensin homolog) for metformin might be a potential cause of pancreatic cancer.Conclusion: Clinicians providing these therapies should stay vigilant to detect pancreatic cancer early.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1673-1683"},"PeriodicalIF":3.0,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143572565","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}

引用次数: 0

A real-world pharmacovigilance study and pharmacological analysis of sulfasalazine based on the FDA adverse event reporting system (FAERS) database. 基于FDA不良事件报告系统（FAERS）数据库的磺胺氮嗪药物警戒研究和药理学分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-09-01 Epub Date: 2025-05-05 DOI: 10.1080/14740338.2025.2488241

Dandan Guo, Bufu Tang, Peng Luo, Jian Zhang, Lvdan Deng, Sentao Fu, Zhijun Shen, Qing Li, Zhao Xie, Na Hang, Hongjie Fan, Ling Wang

{"title":"A real-world pharmacovigilance study and pharmacological analysis of sulfasalazine based on the FDA adverse event reporting system (FAERS) database.","authors":"Dandan Guo, Bufu Tang, Peng Luo, Jian Zhang, Lvdan Deng, Sentao Fu, Zhijun Shen, Qing Li, Zhao Xie, Na Hang, Hongjie Fan, Ling Wang","doi":"10.1080/14740338.2025.2488241","DOIUrl":"10.1080/14740338.2025.2488241","url":null,"abstract":"Objective: The purpose of this study was to use the FDA Adverse Event Reporting System (FAERS) to detect and identify adverse events (AEs) related to sulfasalazine to provide a reference for clinical use.Methods: Four algorithms (ROR, PRR, BCPNN and EBGM) were used to detect sulfasalazine-correlated AE signals in real data to calculate the signals associated with sulfasalazine-related AEs.Results: During the study period, FAERS was used to extract a total of 91,509 sulfasalazine-related (SASP-related) adverse event reports. In total, 6830 sulfasalazine adverse event signals were found, involving 23 organ systems. The analysis revealed several common adverse reactions; the most common were dizziness, malaise, asthenia, decreased appetite, rash, and anemia, and these adverse reactions are listed on the warning label for sulfasalazine. It is worth noting that in our study, in the preferred term (PT), we also found some reactions that were not mentioned on the warning label, such as blurred vision and cardiac failure.Conclusion: This study revealed potential new AEs resulting from sulfasalazine, and further studies are needed to confirm these new AEs.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1775-1783"},"PeriodicalIF":3.0,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144062437","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}

引用次数: 0

Adverse event signal analysis of type Ib MET tyrosine kinase inhibitors based on food and drug administration adverse event reporting system. 基于食品药品监督管理不良事件报告系统的Ib型MET酪氨酸激酶抑制剂不良事件信号分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-09-01 Epub Date: 2025-04-03 DOI: 10.1080/14740338.2025.2487158

Junyu Wang, Rong Ma, Binbin Qu, Xiangpeng Li

{"title":"Adverse event signal analysis of type Ib MET tyrosine kinase inhibitors based on food and drug administration adverse event reporting system.","authors":"Junyu Wang, Rong Ma, Binbin Qu, Xiangpeng Li","doi":"10.1080/14740338.2025.2487158","DOIUrl":"10.1080/14740338.2025.2487158","url":null,"abstract":"Background: Type Ib MET Tyrosine Kinase Inhibitors (TKIs), such as capmatinib, tepotinib, and savolitinib, are used to treat MET-amplified and MET exon 14 deletion mutant non-small cell lung cancer. This pharmacovigilance study analyzed data from the FDA Adverse Event Reporting System (FAERS) between September 2014 and March 2024 to assess adverse events (AEs) for these FDA-approved drugs.Research design and methods: We conducted a systematic search of AEs using MedDRA SMQs by SOC and PT, and performed disproportionality analysis to identify safety signals, calculating ROR, PRR, EBGM, and IC.Results: The analysis identified significant safety signals: capmatinib showed signals for ear and labyrinth disorders, neoplasms, general disorders, and hepatobiliary disorders; tepotinib for renal and urinary disorders, ear and labyrinth disorders, metabolism and nutrition disorders, and general disorders; savolitinib for hepatobiliary disorders. Key PT signals included protein deficiency, scrotal edema, and chylothorax for capmatinib; edema and decreased blood albumin for tepotinib; and abnormal hepatic function for savolitinib.Conclusion: The study highlights differences in the safety profiles of Type Ib MET TKIs, underscoring the need for further regulatory review and possible updates to product labels to better inform clinicians and patients.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1739-1748"},"PeriodicalIF":3.0,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143771742","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}

引用次数: 0

Influence factors of metronidazole-related CNS disorders: an analysis of the Japan adverse drug event report and FDA adverse event reporting system. 甲硝唑相关中枢神经系统疾病的影响因素：日本不良事件报告与FDA不良事件报告制度分析

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-09-01 Epub Date: 2025-04-03 DOI: 10.1080/14740338.2025.2486308

Keisuke Takada, Yuki Enoki, Masaru Samura, Yuki Igarashi, Kazuaki Taguchi, Koji Tanikawa, Kazuaki Matsumoto

{"title":"Influence factors of metronidazole-related CNS disorders: an analysis of the Japan adverse drug event report and FDA adverse event reporting system.","authors":"Keisuke Takada, Yuki Enoki, Masaru Samura, Yuki Igarashi, Kazuaki Taguchi, Koji Tanikawa, Kazuaki Matsumoto","doi":"10.1080/14740338.2025.2486308","DOIUrl":"10.1080/14740338.2025.2486308","url":null,"abstract":"Background: Metronidazole (MNZ) can be administered for various infections. The impact of comorbidities/concomitant drugs on MNZ-induced central nervous system (CNS) disorders remains unclear.Research design and methods: We assessed the risk of metronidazole-related CNS disorders using the Japan Adverse Drug Event Report (JADER, May 2023) and the US Food and Drug Administration Adverse Event Reporting System (FAERS, Q1 2023), excluding comorbidities/concomitant drugs. Clonazepam and diazepam were evaluated as potential prophylactics based on the efficacy of benzodiazepines for MNZ-related CNS disorders. Reporting odds ratios (ROR) and 95% confidence intervals (CI) were calculated. Additionally, sensitivity analysis by sex and age was conducted.Results: The ROR (95% CI) of CNS disorders associated with MNZ in JADER and FAERS were 3.16 (2.69-3.72) and 1.69 (1.64-1.73), respectively. MNZ was significantly related to CNS disorders after excluding comorbidities (brain/spinal cord or liver abscesses) and concomitant drugs (glucocorticoids, antiepileptic, antiparkinson, and schizophrenia drugs). In sensitivity analysis, MNZ was significantly related to CNS disorders, despite sex and age. The ROR in the concomitant with clonazepam (CZP) was 0.70 (0.53-0.92) in FAERS.Conclusion: MNZ may be associated with CNS disorders, even if comorbidities/concomitant drugs that are potential risk factors for CNS disorders are excluded. Additionally, CZP may suppress CNS disorders.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1731-1737"},"PeriodicalIF":3.0,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143751694","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}

引用次数: 0