Expert Opinion on Drug Safety最新文献_第5页

Drug-induced hyperacusis: a disproportionality analysis of the FAERS database.

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-03-06 DOI: 10.1080/14740338.2025.2471516

HuaJie Lin, Qianqian Wang, Haiting Liu, Yong Tang

{"title":"Drug-induced hyperacusis: a disproportionality analysis of the FAERS database.","authors":"HuaJie Lin, Qianqian Wang, Haiting Liu, Yong Tang","doi":"10.1080/14740338.2025.2471516","DOIUrl":"https://doi.org/10.1080/14740338.2025.2471516","url":null,"abstract":"Background: Hyperacusis is a non-negligible clinical condition, but reports related to drug-induced hyperacusis are rare. The aim of this study was to investigate the risk of drug-induced hyperacusis and to identify the top drugs that can cause hyperacusis through the FAERS database.Research design and methods: We used the search term 'hyperacusis' to query all reports of hyperacusis in the FAERS database from 2004(Q1) to 2023(Q4), and extracted, cleaned, mined, and analyzed the data to retrieve the top medications that cause hyperacusis.Result: A total of 2937 unduplicated reports of hyperacusis were found, and the top 10 drugs among them were screened. 6 of them had positive results for all 4 calculations, which was regarded as a strong signal. The likelihood of drug-induced hyperacusis varied considerably between sexes, with females being approximately 2.5 times more likely than males to develop druginduced hyperacusis.Conclusion: By analyzing the FAERS database, we listed drugs with strong hyperacusis that were not suggested on the label and analyzed that the cause of hyperacusis by these drugs is likely to be related to altered levels of 5-HT in the organism. Women are more likely than men to develop pharmacologic hyperacusis.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143566563","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

Incidence and risk of drug-induced interstitial lung disease associated with anti-neoplastic drugs.

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-03-03 DOI: 10.1080/14740338.2025.2472918

Il-Hyung Hwang, Seung Hyeun Lee, Hankil Lee

{"title":"Incidence and risk of drug-induced interstitial lung disease associated with anti-neoplastic drugs.","authors":"Il-Hyung Hwang, Seung Hyeun Lee, Hankil Lee","doi":"10.1080/14740338.2025.2472918","DOIUrl":"10.1080/14740338.2025.2472918","url":null,"abstract":"Background: To evaluate the incidence and risk of drug-induced interstitial lung disease (DIILD) associated with anti-neoplastic drugs among patients with cancer in Korea.Research design and methods: This nested case-control study included 457,685 patients diagnosed with cancer and treated with anti-neoplastic drugs from a retrospective nationwide population-based cohort between 2017 and 2021. The incidence rate of DIILD and the risks of DIILD by anti-neoplastic drug categories were analyzed.Results: Among 270,595 patients, 2,634 developed ILD, resulting in an incidence rate of 4.12 per 1,000 person-years (95% confidence interval (CI): 3.97-4.28). DIILD was more prevalent in men, older patients, and those with a history of pulmonary disease or lung cancer. In a multivariable conditional logistic regression analysis, immune checkpoint inhibitors (odds ratio (OR): 2.37; 95%CI: 1.48-3.78), mammalian target of rapamycin inhibitors (OR: 9.79; 95%CI: 5.20-18.45), antibody-drug conjugates (OR: 7.99; 95%CI: 3.24-19.74), cyclin-dependent kinase 4/6 inhibitors (OR: 2.28; 95%CI: 1.26-4.12), and any combination of different drug categories (OR: 1.93; 95%CI: 1.21-3.09) were associated with an increased risk of DIILD.Conclusion: Our findings suggest that the risk of incident DIILD depends on the category of anti-neoplastic drugs. Patients with identified risk factors and treated with these drugs should be monitored closely.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-9"},"PeriodicalIF":3.0,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143500117","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

Update of safety profile of levonorgestrel: a disproportionality analysis based on FAERS from 2004 to 2023.

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-03-03 DOI: 10.1080/14740338.2025.2472908

Wujiang Lai, Jiemei Liang, Ying Xiang, Qinqin Hu, Jinfa Huang, Milin Chen, Xiting Chen, Bin Sun, Qian Yang, Kaixian Deng

{"title":"Update of safety profile of levonorgestrel: a disproportionality analysis based on FAERS from 2004 to 2023.","authors":"Wujiang Lai, Jiemei Liang, Ying Xiang, Qinqin Hu, Jinfa Huang, Milin Chen, Xiting Chen, Bin Sun, Qian Yang, Kaixian Deng","doi":"10.1080/14740338.2025.2472908","DOIUrl":"10.1080/14740338.2025.2472908","url":null,"abstract":"Background: Levonorgestrel has been utilized in emergency contraception (EC) and for endometrial conditions. While abnormal uterine bleeding is a recognized adverse event (AE), other potential AEs remain undocumented.Research design and methods: Safety data for levonorgestrel were acquired from the United States FDA Adverse Event Reporting System (FAERS) database, covering the period from the first quarter (Q1) of 2004 to the fourth quarter (Q4) of 2023. A disproportionality analysis was conducted to assess the association between levonorgestrel and AEs.Results: A total of 136,168 AEs associated with levonorgestrel were reported. 106 preferred terms (PTs) and 2 system organ class (SOCs) met the criteria established by four algorithms. The identified PTs were vaginal hemorrhage, irregular menstruation, genital hemorrhage and so on. The SOCs encompassed reproductive system and breast disorders, as well as pregnancy, puerperium, and perinatal conditions.Conclusions: Although most findings align with the existing drug inserts for levonorgestrel, several novel AEs were identified in our study. Therefore, ongoing monitoring of this drug is essential and its safety profile should be updated regularly to enhance clinical practice regulation.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-9"},"PeriodicalIF":3.0,"publicationDate":"2025-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143491445","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

Safety evaluation of ILaris: a real-world analysis of adverse events based on the FAERS database.

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-03-02 DOI: 10.1080/14740338.2025.2465864

Xueliang Yi, Shujie Wu, He He, Yingjie Li

{"title":"Safety evaluation of ILaris: a real-world analysis of adverse events based on the FAERS database.","authors":"Xueliang Yi, Shujie Wu, He He, Yingjie Li","doi":"10.1080/14740338.2025.2465864","DOIUrl":"10.1080/14740338.2025.2465864","url":null,"abstract":"Background: There is a lack of real-world studies on the safety of Ilaris in large populations. The purpose of this study was to investigate adverse events (AEs) associated with Ilaris using data from the FDA Adverse Event Reporting System (FAERS) database to guide clinical use.Methods: We evaluated retrospectively extracted reports of AEs from the FAERS database between the first quarter of 2009 and the second quarter of 2024. The presence of a significant association between Ilaris and AEs was assessed by using disproportionality analyses including ROR,PRR,BCPNN,MGPS.Results: After evaluating 14,691,170 data, 7968 ILaris-associated AEs were obtained after removing duplicates and unspecified sex items. A number of AEs were finalized through the study, including Common Pyrexia, Condition Aggravated, Influenza, and unexpected signals not listed in the drug insert, such as Pulmonary Thrombosis, Hepatomegaly, Blood Lactate Dehydrogenase Increased, Splenomegaly, Appendicitis. Ilaris induced AEs involving 27 system organ classes (SOCs). There were gender differences in AEs signaling associated with Ilaris.Conclusions: It is critical for healthcare professionals to closely monitor patients for symptoms (such as pulmonary thrombosis, Hepatomegaly, Blood Lactate Dehydrogenase Increased, Splenomegaly, Appendicitis) and other adverse events during treatment.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-13"},"PeriodicalIF":3.0,"publicationDate":"2025-03-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143476140","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

Post-marketing safety of Adagrasib: a disproportionality analysis based on the FAERS database. Adagrasib上市后的安全性：基于FAERS数据库的比例失调分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-03-02 DOI: 10.1080/14740338.2025.2468866

Zheng Shi, Xiayao Yu, Yifan Zhao, Keda Shao, Chunwei Xu, Zhengbo Song

{"title":"Post-marketing safety of Adagrasib: a disproportionality analysis based on the FAERS database.","authors":"Zheng Shi, Xiayao Yu, Yifan Zhao, Keda Shao, Chunwei Xu, Zhengbo Song","doi":"10.1080/14740338.2025.2468866","DOIUrl":"10.1080/14740338.2025.2468866","url":null,"abstract":"Background: Adagrasib is a novel KRAS G12C inhibitor. While its clinical efficacy has been demonstrated, comprehensive post-marketing safety data remain limited. This study aimed to analyze adverse reactions involving Adagrasib from the FAERS database to identify potential safety signals.Research design and methods: A retrospective pharmacovigilance analysis was performed using FAERS data during Q4 2022 through Q2 2024. After deduplication. disproportionality analysis was performed using four algorithms: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayes Geometric Mean (EBGM).Results: A total of 598 cases involving Adagrasib were identified, encompassing 1717 adverse events (AEs). The most common AEs were diarrhea, nausea, vomiting, asthenia, and decreased appetite. New strong significant AE signals were detected, including dissociation, status epilepticus, cerebral disorder, and photosensitivity reaction. The median time to AE onset was 34 days, and most AEs happened within the initial month of treatment.Conclusions: Our study highlights some new AE signals associated with Adagrasib, emphasizing the importance of continued pharmacovigilance. While the findings contribute to understanding Adagrasib's safety profile, further validation through large-scale prospective studies is needed.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-8"},"PeriodicalIF":3.0,"publicationDate":"2025-03-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143514953","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

Risk of acute renal failure associated with combined use of SGLT2 inhibitors and potentially nephrotoxic drugs: an epidemiological surveillance study based on the FDA adverse event reporting system (FAERS).

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-03-02 DOI: 10.1080/14740338.2025.2471529

Ting Yu, Jian Xiao, Mengyao Li, Shu Qiao Cheng, Ruwen Cai, Ling Huang, Huimin Yu, Jing Yang Li, Ying-Ying Zhang, Ying Wang

{"title":"Risk of acute renal failure associated with combined use of SGLT2 inhibitors and potentially nephrotoxic drugs: an epidemiological surveillance study based on the FDA adverse event reporting system (FAERS).","authors":"Ting Yu, Jian Xiao, Mengyao Li, Shu Qiao Cheng, Ruwen Cai, Ling Huang, Huimin Yu, Jing Yang Li, Ying-Ying Zhang, Ying Wang","doi":"10.1080/14740338.2025.2471529","DOIUrl":"10.1080/14740338.2025.2471529","url":null,"abstract":"Background: Limited knowledge exists regarding nephrotoxic risks associated with the combination of sodium-glucose co-transporter-2 inhibitors (SGLT2i) and potentially nephrotoxic drugs. This study evaluates acute renal failure (ARF) events linked to such combinations using data from the FDA Adverse Event Reporting System (FAERS).Methods: Signal mining was performed by estimating reporting odds ratios (ROR), with validation through additive, multiplicative, and proportional reporting ratio (PRR) models. Logistic regression assessed mortality risk factors.Results: Among 4,417,195 reports, 1,636 ARF cases were associated with SGLT2i combinations, primarily involving diuretics, lipid-lowering agents, and anticoagulants. The highest ARF risk was observed with dapagliflozin-cefazolin [ROR adjusted (a) 59.63, 95% CI (9.96, 356.87); ROR adjusted (b) 19.88, 95% CI (1.80, 219.21); additive model (0.53); multiplicative model (8.36); PRR (8.53)]. Consistent associations were found for empagliflozin-allopurinol and canagliflozin-vancomycin. Among single drugs, 12, including canagliflozin, met all four significance criteria for ARF signals. Logistic regression revealed male patients had higher mortality risk (OR = 0.356, p = 0.043).Conclusion: This study confirms prior evidence of ARF associated with the combined use of SGLT2i with diuretics or NSAIDs and identifies new risks with proton pump inhibitors (PPIs), antigout medications, and anticoagulants. Male gender was a significant risk factor.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-12"},"PeriodicalIF":3.0,"publicationDate":"2025-03-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143476052","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

Real-world analysis of levetiracetam-associated rhabdomyolysis: insights from the FDA adverse event reporting system. 左乙拉西坦相关横纹肌溶解症的真实世界分析：美国食品药品管理局不良事件报告系统的启示。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-03-01 Epub Date: 2024-11-08 DOI: 10.1080/14740338.2024.2421340

Guo Yinan, Gong Guangming, Guo Guangyu, Cheng Xianghai, Yin Jingwen, Qin Jie

{"title":"Real-world analysis of levetiracetam-associated rhabdomyolysis: insights from the FDA adverse event reporting system.","authors":"Guo Yinan, Gong Guangming, Guo Guangyu, Cheng Xianghai, Yin Jingwen, Qin Jie","doi":"10.1080/14740338.2024.2421340","DOIUrl":"10.1080/14740338.2024.2421340","url":null,"abstract":"Background: Levetiracetam, a widely prescribed antiseizure medication, is recognized for its broad-spectrum efficacy, good tolerability, and minimal drug interactions. This study examines the association between levetiracetam and rhabdomyolysis, utilizing real-world data from the FDA Adverse Event Reporting System (FAERS) database to further elucidate its safety profile.Methods: This study extracted adverse events related to levetiracetam from the FAERS database (Q1 2013 to Q1 2024). Four types of disproportionality analysis identified rhabdomyolysis as a significant adverse event. Logistic regression assessed risk factors, including gender, age, and severity. A Gaussian Mixture Model analyzed the time-to-onset distribution of rhabdomyolysis, while the impact of concomitant medications on its risk was evaluated using Reporting Odds Ratio (ROR).Results: Levetiracetam significantly increased rhabdomyolysis risk (ROR = 13.5). Males showed a higher incidence (OR = 2.60). Most adverse events occurred within the first 30 days, with a bimodal onset distribution. Co-administration of antibiotics, antipsychotics, and PPIs elevated the risk while other antiseizure medications did not.Conclusion: This study found a significant association between levetiracetam and the risk of rhabdomyolysis, highlighting the need for increased clinical vigilance in this patient population. Future research should focus on elucidating the underlying mechanisms and optimizing clinical guidelines.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"377-388"},"PeriodicalIF":3.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142497753","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

Safety and efficacy of pharmacotherapies for pelvic inflammatory disease and endometriosis. 盆腔炎和子宫内膜异位症药物治疗的安全性和有效性。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-03-01 Epub Date: 2025-01-02 DOI: 10.1080/14740338.2024.2446424

Simone Ferrero, Umberto Leone Roberti Maggiore, Michele Paudice, Valerio Gaetano Vellone, Umberto Perrone, Fabio Barra

{"title":"Safety and efficacy of pharmacotherapies for pelvic inflammatory disease and endometriosis.","authors":"Simone Ferrero, Umberto Leone Roberti Maggiore, Michele Paudice, Valerio Gaetano Vellone, Umberto Perrone, Fabio Barra","doi":"10.1080/14740338.2024.2446424","DOIUrl":"10.1080/14740338.2024.2446424","url":null,"abstract":"Introduction: Endometriosis and pelvic inflammatory disease (PID) are gynecological conditions affecting women of reproductive age and causing pain symptoms. The symptoms caused by these conditions are similar; thus, the differential diagnosis may be challenging. The treatment of these conditions is very different because PID is treated with antibiotic therapy, while endometriosis is treated with hormonal therapies suppressing estrogen levels.Areas covered: A narrative review was conducted through a comprehensive literature search on endometriosis and PID. The search strategy incorporated relevant keywords and MeSH terms related to these topics.Expert opinion: The antibiotics used to manage PID have high efficacy and safety profiles. Commonly prescribed regimens include a combination of ceftriaxone, doxycycline, and metronidazole. These antibiotics are generally well-tolerated, with most adverse effects being mild and manageable (gastrointestinal disturbances or hypersensitivity reactions). Hormonal therapies are a cornerstone in the management of endometriosis; they include combined oral contraceptives (COCs), progestins, gonadotropin-releasing hormone (GnRH) agonists, and antagonists. COCs and progestins are generally well-tolerated with a favorable safety profile, though they may cause side effects (breakthrough bleeding and mood changes). Oral GnRH antagonists have emerged as a noteworthy option, offering partial estrogen suppression and thereby overcoming the limitations associated with previously used GnRH agonists.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"273-286"},"PeriodicalIF":3.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142881684","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

The role of artificial intelligence in pharmacovigilance for rare diseases. 人工智能在罕见病药物警戒中的作用。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-03-01 DOI: 10.1080/14740338.2025.2474645

Ashish Jain, Zahabia Adenwala

{"title":"The role of artificial intelligence in pharmacovigilance for rare diseases.","authors":"Ashish Jain, Zahabia Adenwala","doi":"10.1080/14740338.2025.2474645","DOIUrl":"https://doi.org/10.1080/14740338.2025.2474645","url":null,"abstract":"Introduction: There are considerable gaps in the conventional pharmacovigilance (PV) measures which might result in significant safety issues, especially in monitoring the effectiveness of orphan drugs that are used to treat rare diseases. In this paper, we evaluate if and how Artificial Intelligence (AI) and Machine Learning (ML) can be used to mitigate these problems.Areas covered: The article identifies ineffective adverse events (AE) reporting systems, low patient enrollment, and weak signal monitoring as barriers to the effective safety evaluation of rare diseases. It also addresses the possibility of employing AI and ML technologies to automate the reporting of AEs by integrating data from multiple sources and increasing the sensitivity of risk detection. The method to conduct the literature search consisted of searching Pubmed and Google Scholar for relevant AI and ML studies and publications aboqut PV.Expert opinion: We identified technical and regulatory concerns such as privacy and model explainability as hurdles to the adoption of AI in PV. However, the same technology, if properly integrated into the system, has the potential to enhance treatment monitoring for rare diseases and to increase the rate of new therapies being developed.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143531579","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 of FDA Adverse Event Reporting System (FAERS) for gemcitabine. 针对吉西他滨的 FDA 不良事件报告系统 (FAERS) 真实世界药物警戒研究。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-03-01 Epub Date: 2024-10-24 DOI: 10.1080/14740338.2024.2419999

Cheng Zhang, Ke Li, Shu-Ning Xu, Lei Qiao, Yu-Lin Ren, Qun Li, Ying Liu

{"title":"A real-world pharmacovigilance study of FDA Adverse Event Reporting System (FAERS) for gemcitabine.","authors":"Cheng Zhang, Ke Li, Shu-Ning Xu, Lei Qiao, Yu-Lin Ren, Qun Li, Ying Liu","doi":"10.1080/14740338.2024.2419999","DOIUrl":"10.1080/14740338.2024.2419999","url":null,"abstract":"Background: Gemcitabine is widely used in the treatment of various cancers. This study aims to evaluate gemcitabine-associated adverse events (AEs) using the Food and Drug Administration Adverse Event Reporting System (FAERS) database.Research design and methods: We analyzed data spanning from January 2004 to June 2023. Employing reporting odds ratio (ROR) and Bayesian confidence propagation neural network (BCPNN) algorithms, we identified AEs with positive signals in patients administered gemcitabine.Results: Out of 16,623,939 reports, 23,645 involved gemcitabine as the 'primary suspected (PS)' resulting in 74,306 AEs. Consistent with the reports in the specification and clinical trials, thrombocytopenia, pyrexia, neutropenia, and anemia were the most common AEs. Notably, our study identified some unexpected AEs such as abdominal pain, pleural effusion, ascites, and gastrointestinal hemorrhage, among others. The most significant SOC was 'Blood and lymphatic system disorders'. The median onset time for gemcitabine-related AEs was 24 days (interquartile range [IQR] 6-82 days), with most cases occurring within the initial 30 days following gemcitabine administration.Conclusion: Gemcitabine is associated with a broad spectrum of AEs affecting multiple organ systems, with a notable incidence of hospitalization. The study highlights both expected and unexpected AEs, which could enhance future clinical applications and safety of gemcitabine.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"365-376"},"PeriodicalIF":3.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142497750","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