Pub Date : 2024-10-31DOI: 10.1080/14740338.2024.2423680
Xiao Tang, Fuchun Zheng, Zifang Ma, Huilong Shen, Zhijun Yao
Background: Leuprorelin, a gonadotropin-releasing hormone agonist, is widely used to treat hormone-related disorders. This study aims to explore and analyze the safety profile of leuprorelin by examining adverse event reports from the FDA Adverse Event Reporting System (FAERS) database.
Methods: This study conducted a retrospective pharmacovigilance analysis using FAERS data from Q1 2004 to Q1 2024. Adverse drug events (ADEs) related to leuprorelin were identified and categorized by system organ class and specific adverse events. Statistical methods such as Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayesian Geometric Mean (EBGM) were used to detect safety signals.
Results: A total of 63,928 ADE reports implicated leuprorelin, with 500 preferred terms and 25 system organ classes showing significant disproportionality. Notable rare ADEs identified were bulbospinal muscular atrophy congenital (n = 26; ROR 1282.72, PRR 1282.52, IC 7.91, EBGM 241.28), follicular cystitis (n = 3; ROR 126.84, PRR 126.84, IC 6.48, EBGM 89.09), and anaplastic meningioma (n = 3; ROR 46.73, PRR 46.73, IC 5.34, EBGM 40.5).
Conclusion: Most findings were expected, but new signals like follicular cystitis, previously unreported, emerged. Further studies are essential to validate these findings, crucial for clinical monitoring and risk identification of leuprorelin.
{"title":"Comprehensive evaluation of leuprorelin-associated adverse events: insights from FDA adverse event reporting system.","authors":"Xiao Tang, Fuchun Zheng, Zifang Ma, Huilong Shen, Zhijun Yao","doi":"10.1080/14740338.2024.2423680","DOIUrl":"10.1080/14740338.2024.2423680","url":null,"abstract":"<p><strong>Background: </strong>Leuprorelin, a gonadotropin-releasing hormone agonist, is widely used to treat hormone-related disorders. This study aims to explore and analyze the safety profile of leuprorelin by examining adverse event reports from the FDA Adverse Event Reporting System (FAERS) database.</p><p><strong>Methods: </strong>This study conducted a retrospective pharmacovigilance analysis using FAERS data from Q1 2004 to Q1 2024. Adverse drug events (ADEs) related to leuprorelin were identified and categorized by system organ class and specific adverse events. Statistical methods such as Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayesian Geometric Mean (EBGM) were used to detect safety signals.</p><p><strong>Results: </strong>A total of 63,928 ADE reports implicated leuprorelin, with 500 preferred terms and 25 system organ classes showing significant disproportionality. Notable rare ADEs identified were bulbospinal muscular atrophy congenital (<i>n</i> = 26; ROR 1282.72, PRR 1282.52, IC 7.91, EBGM 241.28), follicular cystitis (<i>n</i> = 3; ROR 126.84, PRR 126.84, IC 6.48, EBGM 89.09), and anaplastic meningioma (<i>n</i> = 3; ROR 46.73, PRR 46.73, IC 5.34, EBGM 40.5).</p><p><strong>Conclusion: </strong>Most findings were expected, but new signals like follicular cystitis, previously unreported, emerged. Further studies are essential to validate these findings, crucial for clinical monitoring and risk identification of leuprorelin.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2024-10-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142521486","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}
Introduction: Carbamazepine (CBZ) is a commonly used antiseizures medications (ASM), but its adverse drug reactions (ADRs) can impact the successful management of epilepsy. There are currently limited systematic studies on ADRs related to CBZ, necessitating further investigation.
Areas covered: Using the FDA Adverse Event Reporting System (FAERS) database , we extracted reports where CBZ was the primary suspect, conducting subgroup analyses stratified by sex and age. Four risk signal detection methods ROR, PRR, BCPNN, and EGBM were employed to systematically analyze the ADRs associated with CBZ.
Expert opinion: In the epilepsy population, ADRs related to CBZ often involve examinations, hereditary disorders, and infections. Subgroup analysis showed differences in ADR signals among male, female, elderly, and young patients. Human Herpesvirus 6 Infection and Dermatitis Exfoliative were consistent CBZ-induced ADRs, unaffected by age or sex. The study also identified previously overlooked ADRs such as bone metabolism abnormalities, ocular toxicity, and ototoxicity. Many ADRs linked to CBZ remain underreported. It is crucial to enhance monitoring and information dissemination about CBZ use in epileptic patients. Adjusting medication regimens for high-risk individuals, potentially incorporating acupuncture, traditional Chinese medicine, or alternative anti-seizure medications, should be considered when necessary.
{"title":"Adverse events associated with carbamazepine: a pharmacovigilance study using the FDA Adverse Event Reporting System.","authors":"Shulan Huang, Hanlin Dong, Dongqiang Luo, Jiazhen Jiang, Manting Liu, Jiayu Wu, Xiangyun Dou, Siyuan Zhou","doi":"10.1080/14740338.2024.2416926","DOIUrl":"https://doi.org/10.1080/14740338.2024.2416926","url":null,"abstract":"<p><strong>Introduction: </strong>Carbamazepine (CBZ) is a commonly used antiseizures medications (ASM), but its adverse drug reactions (ADRs) can impact the successful management of epilepsy. There are currently limited systematic studies on ADRs related to CBZ, necessitating further investigation.</p><p><strong>Areas covered: </strong>Using the FDA Adverse Event Reporting System (FAERS) database , we extracted reports where CBZ was the primary suspect, conducting subgroup analyses stratified by sex and age. Four risk signal detection methods ROR, PRR, BCPNN, and EGBM were employed to systematically analyze the ADRs associated with CBZ.</p><p><strong>Expert opinion: </strong>In the epilepsy population, ADRs related to CBZ often involve examinations, hereditary disorders, and infections. Subgroup analysis showed differences in ADR signals among male, female, elderly, and young patients. Human Herpesvirus 6 Infection and Dermatitis Exfoliative were consistent CBZ-induced ADRs, unaffected by age or sex. The study also identified previously overlooked ADRs such as bone metabolism abnormalities, ocular toxicity, and ototoxicity. Many ADRs linked to CBZ remain underreported. It is crucial to enhance monitoring and information dissemination about CBZ use in epileptic patients. Adjusting medication regimens for high-risk individuals, potentially incorporating acupuncture, traditional Chinese medicine, or alternative anti-seizure medications, should be considered when necessary.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2024-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142497751","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}
Pub Date : 2024-10-25DOI: 10.1080/14740338.2024.2418950
Hannah Conn, Joseph Jankovic
Introduction: Drug-induced parkinsonism (DIP) is one of the most common iatrogenic movement disorders. It is characterized by tremors, slowness of movement, and shuffling gait with postural instability, clinically indistinguishable from idiopathic Parkinson's disease. Prior exposure to antipsychotic medications or other dopamine receptor blocking agents (DRBAs) is required for the diagnosis.
Areas covered: This article aims to review the epidemiology, pathophysiology, clinical features, ancillary testing, and treatment of DIP. A literature search was undertaken in PubMed from January 2013 to January 2024.
Expert opinion: A clinician's suspicion of DIP must always be present when a patient develops acute to subacute onset of parkinsonism while taking a DRBA. As DIP can be indistinguishable from idiopathic PD, ancillary testing, such as DaTscans and skin biopsy searching for alpha-synuclein deposits, are often required to make a definitive diagnosis. When DIP develops, steps should be taken to discontinue the offending agent or, in the case of antipsychotics, dose reduction or change to an agent with lower risk for DIP, such as quetiapine or clozapine. Prophylactic treatment with anticholinergics is not indicated.
{"title":"Drug-induced parkinsonism: diagnosis and treatment.","authors":"Hannah Conn, Joseph Jankovic","doi":"10.1080/14740338.2024.2418950","DOIUrl":"10.1080/14740338.2024.2418950","url":null,"abstract":"<p><strong>Introduction: </strong>Drug-induced parkinsonism (DIP) is one of the most common iatrogenic movement disorders. It is characterized by tremors, slowness of movement, and shuffling gait with postural instability, clinically indistinguishable from idiopathic Parkinson's disease. Prior exposure to antipsychotic medications or other dopamine receptor blocking agents (DRBAs) is required for the diagnosis.</p><p><strong>Areas covered: </strong>This article aims to review the epidemiology, pathophysiology, clinical features, ancillary testing, and treatment of DIP. A literature search was undertaken in PubMed from January 2013 to January 2024.</p><p><strong>Expert opinion: </strong>A clinician's suspicion of DIP must always be present when a patient develops acute to subacute onset of parkinsonism while taking a DRBA. As DIP can be indistinguishable from idiopathic PD, ancillary testing, such as DaTscans and skin biopsy searching for alpha-synuclein deposits, are often required to make a definitive diagnosis. When DIP develops, steps should be taken to discontinue the offending agent or, in the case of antipsychotics, dose reduction or change to an agent with lower risk for DIP, such as quetiapine or clozapine. Prophylactic treatment with anticholinergics is not indicated.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2024-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142461467","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}
Pub Date : 2024-10-24DOI: 10.1080/14740338.2024.2419999
Cheng Zhang, Ke Li, Shu-Ning Xu, Lei Qiao, Yu-Lin Ren, Qun Li, Ying Liu
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.
{"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":"https://doi.org/10.1080/14740338.2024.2419999","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Research design and methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2024-10-24","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}
Pub Date : 2024-10-23DOI: 10.1080/14740338.2024.2418333
Toru Ogura, Chihiro Shiraishi
Background: Olaparib, niraparib, and rucaparib are the three primary poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitors that are currently available in the market. Previous studies indicate different incidences of adverse events based on the PARP inhibitor or country.
Research design and methods: This study used data from the United States Food and Drug Administration Adverse Event Reporting System collected between January 2018 and December 2023. The data analyzed in this study involved patients receiving PARP inhibitors for treating ovarian cancer. A comparative analysis of the three PARP inhibitors was conducted using the reporting odds ratio (ROR) and the adjusted ROR (aROR) controlling for patient background differences.
Results: The aROR for niraparib was significant at > 1.000, including platelet count decreased (p < 0.001) and thrombocytopenia (p < 0.001) when olaparib was set as the reference. Conversely, the aROR for niraparib was significant at < 1.000, including anemia (p < 0.001). Additionally, significant differences were observed in various adverse events for rucaparib. Moreover, significant differences were observed when comparing between countries.
Conclusions: This study indicates that the types of adverse events may vary by PARP inhibitor and by country. These results will be beneficial in clinical practice.
背景:奥拉帕利(Olaparib)、尼拉帕利(niraparib)和鲁卡帕利(rucaparib)是目前市场上三种主要的多(腺苷二磷酸核糖)聚合酶(PARP)抑制剂。以往的研究表明,PARP抑制剂或国家不同,不良事件的发生率也不同:本研究使用的数据来自美国食品和药物管理局不良事件报告系统,收集时间为 2018 年 1 月至 2023 年 12 月。本研究分析的数据涉及接受PARP抑制剂治疗卵巢癌的患者。使用报告几率(ROR)和控制患者背景差异的调整ROR(aROR)对三种PARP抑制剂进行了比较分析:结果:尼拉帕利的aROR大于1.000,包括血小板计数下降(p p p 结论:尼拉帕利的aROR显著大于1.000:这项研究表明,不同 PARP 抑制剂和不同国家的不良事件类型可能有所不同。这些结果将有助于临床实践。
{"title":"Comparison of adverse events of poly adenosine diphosphate ribose polymerase inhibitors in patients with ovarian cancer using the United States Food and Drug Administration Adverse Event Reporting System.","authors":"Toru Ogura, Chihiro Shiraishi","doi":"10.1080/14740338.2024.2418333","DOIUrl":"10.1080/14740338.2024.2418333","url":null,"abstract":"<p><strong>Background: </strong>Olaparib, niraparib, and rucaparib are the three primary poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitors that are currently available in the market. Previous studies indicate different incidences of adverse events based on the PARP inhibitor or country.</p><p><strong>Research design and methods: </strong>This study used data from the United States Food and Drug Administration Adverse Event Reporting System collected between January 2018 and December 2023. The data analyzed in this study involved patients receiving PARP inhibitors for treating ovarian cancer. A comparative analysis of the three PARP inhibitors was conducted using the reporting odds ratio (ROR) and the adjusted ROR (aROR) controlling for patient background differences.</p><p><strong>Results: </strong>The aROR for niraparib was significant at > 1.000, including platelet count decreased (<i>p</i> < 0.001) and thrombocytopenia (<i>p</i> < 0.001) when olaparib was set as the reference. Conversely, the aROR for niraparib was significant at < 1.000, including anemia (<i>p</i> < 0.001). Additionally, significant differences were observed in various adverse events for rucaparib. Moreover, significant differences were observed when comparing between countries.</p><p><strong>Conclusions: </strong>This study indicates that the types of adverse events may vary by PARP inhibitor and by country. These results will be beneficial in clinical practice.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142461464","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}
Pub Date : 2024-10-23DOI: 10.1080/14740338.2024.2418319
Hong Pan, Shasha Lin
Background: The primary objective of this research is to conduct an exhaustive evaluation of rimegepant with the Food and Drug Administration Adverse Event Reporting System (FAERS) repository.
Research design and methods: This study downloaded the reporting files related to rimegepant from the second quarter of 2020 to the first quarter of 2024. Disproportionality analysis was utilized to explore the relationship between rimegepant and adverse drug events (ADEs).
Results: This study analyzed 6659 ADE reports associated with rimegepant as the primary suspected (PS) drug. In the disproportionate analysis of system organ classes (SOCs), the significant signal for rimegepant was general disorders and administration site conditions.On the preferred terms level, 35 ADEs were identified following the exclusion. The top five ADEs with high signal strengths were medication overuse headache, nasal edema, tension headache, performance status decreased, and motion sickness. The most frequent ADEs were nausea, feeling abnormal, abdominal pain upper, somnolence, and hypersensitivity. In addition, we need to pay attention to the ADEs not mentioned in the instruction and clinically significant: vertigo, hyperacusis, somnolence, Raynaud's phenomenon, motion sickness, panic attack, and fear.
Conclusions: This study highlights previously unrecognized safety concerns associated with the use of rimegepant. These novel safety aspects suggest that while these treatments can be effective, additional risks may need further exploration.
{"title":"A real-world adverse events study of rimegepant from the FAERS database.","authors":"Hong Pan, Shasha Lin","doi":"10.1080/14740338.2024.2418319","DOIUrl":"10.1080/14740338.2024.2418319","url":null,"abstract":"<p><strong>Background: </strong>The primary objective of this research is to conduct an exhaustive evaluation of rimegepant with the Food and Drug Administration Adverse Event Reporting System (FAERS) repository.</p><p><strong>Research design and methods: </strong>This study downloaded the reporting files related to rimegepant from the second quarter of 2020 to the first quarter of 2024. Disproportionality analysis was utilized to explore the relationship between rimegepant and adverse drug events (ADEs).</p><p><strong>Results: </strong>This study analyzed 6659 ADE reports associated with rimegepant as the primary suspected (PS) drug. In the disproportionate analysis of system organ classes (SOCs), the significant signal for rimegepant was general disorders and administration site conditions.On the preferred terms level, 35 ADEs were identified following the exclusion. The top five ADEs with high signal strengths were medication overuse headache, nasal edema, tension headache, performance status decreased, and motion sickness. The most frequent ADEs were nausea, feeling abnormal, abdominal pain upper, somnolence, and hypersensitivity. In addition, we need to pay attention to the ADEs not mentioned in the instruction and clinically significant: vertigo, hyperacusis, somnolence, Raynaud's phenomenon, motion sickness, panic attack, and fear.</p><p><strong>Conclusions: </strong>This study highlights previously unrecognized safety concerns associated with the use of rimegepant. These novel safety aspects suggest that while these treatments can be effective, additional risks may need further exploration.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142461458","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}
Objective: Our study aims to assess alendronate-related adverse events (AEs) from the US FDA adverse event reporting system database.
Methods: The AE data associated with alendronate between the first quarter of 2004 and the first quarter of 2024 were selected. Various signal quantification methods, including the ROR, PRR, BCPNN, and EBGM, were applied for analysis.
Results: In 34,943 reports where alendronate was the primary suspected drug for the AE, 24 affected system organ classes and 1046 significant preferred terms were identified in this study. Several significant AEs beyond drug instructions with strong signals were determined, including low turnover osteopathy, fracture delayed union, fracture nonunion, loss of anatomical alignment after fracture reduction, fracture malunion, periprosthetic fracture, carotid bruit, oral fibroma, traumatic occlusion, and phlebolith. The median time to onset of alendronate-related AEs was 306 days (interquartile range [IQR] 12-1,461 days), and the majority of cases occurred 2 years later (18.80%) and within 30 days (14.49%).
Conclusions: The current study detected multiple potential new AE signals for alendronate, and more clinical research is required to further validate our results and clarify their associations.
{"title":"Mining and analysis of adverse event signals for alendronate based on the real-world data of FDA adverse event reporting system database.","authors":"Ziyi Zhao, Hongxiang Ji, Chenghao Zhang, Zhengdan Wang, Shengquan Ren, Chunlei Liu, Caifeng Wu, Jian Wang, Xiaoheng Ding","doi":"10.1080/14740338.2024.2419995","DOIUrl":"10.1080/14740338.2024.2419995","url":null,"abstract":"<p><strong>Objective: </strong>Our study aims to assess alendronate-related adverse events (AEs) from the US FDA adverse event reporting system database.</p><p><strong>Methods: </strong>The AE data associated with alendronate between the first quarter of 2004 and the first quarter of 2024 were selected. Various signal quantification methods, including the ROR, PRR, BCPNN, and EBGM, were applied for analysis.</p><p><strong>Results: </strong>In 34,943 reports where alendronate was the primary suspected drug for the AE, 24 affected system organ classes and 1046 significant preferred terms were identified in this study. Several significant AEs beyond drug instructions with strong signals were determined, including low turnover osteopathy, fracture delayed union, fracture nonunion, loss of anatomical alignment after fracture reduction, fracture malunion, periprosthetic fracture, carotid bruit, oral fibroma, traumatic occlusion, and phlebolith. The median time to onset of alendronate-related AEs was 306 days (interquartile range [IQR] 12-1,461 days), and the majority of cases occurred 2 years later (18.80%) and within 30 days (14.49%).</p><p><strong>Conclusions: </strong>The current study detected multiple potential new AE signals for alendronate, and more clinical research is required to further validate our results and clarify their associations.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142461470","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}
Pub Date : 2024-10-22DOI: 10.1080/14740338.2024.2418326
Ying Zhou, Na Li, Guowei Ma, Ning Su, Jiang Liu, Wenxi Yue, Rui Yin, Jie Chen
Objective: By analyzing the signal mining of vandetanib AEs, it provides a reference for the rational clinical use of the drug.
Methods: This study provides signal detection and analysis of AEs associated with vandetanib using the FAERS from Q2 2011 to Q1 2023.
Results: Disproportionality analyses were conducted using the ROR and the MHRA method, with AEs categorized and described based on SOC and PT from the MedDRA. A total of 1,721 AEs reports identified vandetanib as the primary suspect. The analyses yielded 187 AEs signals across 20 SOCs categories, with 47 signals not previously reported in the vandetanib labeling. Additionally, the study analyzes factors influencing AEs. The results are as follows: There are significant differences in Investigations based on gender and nationality (p < 0.05); skin and subcutaneous tissue disorders and gastrointestinal disorders exhibit differences based on gender, age, and nationality (p < 0.05).
Conclusion: Common AEs signals identified align with those documented in the drug labeling. However, AEs such as tumor lysis syndrome, skin discoloration, and pigmentary disorders, which are not listed in the labeling, warrant special attention. It is essential that abnormalities in patients' skin and laboratory indicators are closely monitored and addressed promptly to safeguard medication safety.
{"title":"Mining and analysis of adverse event signals of vandetanib based on the FAERS database.","authors":"Ying Zhou, Na Li, Guowei Ma, Ning Su, Jiang Liu, Wenxi Yue, Rui Yin, Jie Chen","doi":"10.1080/14740338.2024.2418326","DOIUrl":"10.1080/14740338.2024.2418326","url":null,"abstract":"<p><strong>Objective: </strong>By analyzing the signal mining of vandetanib AEs, it provides a reference for the rational clinical use of the drug.</p><p><strong>Methods: </strong>This study provides signal detection and analysis of AEs associated with vandetanib using the FAERS from Q2 2011 to Q1 2023.</p><p><strong>Results: </strong>Disproportionality analyses were conducted using the ROR and the MHRA method, with AEs categorized and described based on SOC and PT from the MedDRA. A total of 1,721 AEs reports identified vandetanib as the primary suspect. The analyses yielded 187 AEs signals across 20 SOCs categories, with 47 signals not previously reported in the vandetanib labeling. Additionally, the study analyzes factors influencing AEs. The results are as follows: There are significant differences in Investigations based on gender and nationality (<i>p</i> < 0.05); skin and subcutaneous tissue disorders and gastrointestinal disorders exhibit differences based on gender, age, and nationality (<i>p</i> < 0.05).</p><p><strong>Conclusion: </strong>Common AEs signals identified align with those documented in the drug labeling. However, AEs such as tumor lysis syndrome, skin discoloration, and pigmentary disorders, which are not listed in the labeling, warrant special attention. It is essential that abnormalities in patients' skin and laboratory indicators are closely monitored and addressed promptly to safeguard medication safety.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142461471","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}
Pub Date : 2024-10-22DOI: 10.1080/14740338.2024.2420148
{"title":"Correction.","authors":"","doi":"10.1080/14740338.2024.2420148","DOIUrl":"https://doi.org/10.1080/14740338.2024.2420148","url":null,"abstract":"","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142497752","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}
Background: Tezepelumab is the first asthma biologic approved by the FDA that is not restricted by biomarker phenotypes. To date, there have been no studies reporting adverse events (AEs) associated with the real-world use of tezepelumab.
Research design and methods: This study included a comprehensive evaluation of AE reports related to tezepelumab since its approval (4th quarter of 2021 to 1st quarter of 2024) using the FAERS database, and compared with the currently reported clinical trial results (ClinicalTrials.gov).
Results: A total of 2153 reports of tezepelumab-related AEs were extracted. 256 preferred terms (PTs) of adverse reactions involving 27 system organ classes were identified. Significant AEs that were not reported on the drug label, such as 'dyspnea,' 'body temperature,' and 'tongue pruritus,' were reported. The median time to onset (TTO) of tezepelumab-related AEs was 35 days.The most frequent AEs in different sexes were 'arthralgia' and 'dyspnea,' with differences in signal strength ranking between the sexes.
Conclusions: This study represents the largest report to date on tezepelumab-related AEs, providing valuable insights into the potential side effects of tezepelumab. This work is crucial for the broader clinical application of this novel biologic and improving outcomes for patients with severe asthma.
{"title":"Adverse events associated with tezepelumab: a safety analysis of clinical trials and a pharmacovigilance system.","authors":"Zhenyu Mao, Yuchen Huang, Xiaoyan Zhu, Pengdou Zheng, Lingling Wang, Fengqin Zhang, Wei Liu, Huiguo Liu, Wenhui Liao, Ling Zhou","doi":"10.1080/14740338.2024.2416921","DOIUrl":"https://doi.org/10.1080/14740338.2024.2416921","url":null,"abstract":"<p><strong>Background: </strong>Tezepelumab is the first asthma biologic approved by the FDA that is not restricted by biomarker phenotypes. To date, there have been no studies reporting adverse events (AEs) associated with the real-world use of tezepelumab.</p><p><strong>Research design and methods: </strong>This study included a comprehensive evaluation of AE reports related to tezepelumab since its approval (4th quarter of 2021 to 1st quarter of 2024) using the FAERS database, and compared with the currently reported clinical trial results (ClinicalTrials.gov).</p><p><strong>Results: </strong>A total of 2153 reports of tezepelumab-related AEs were extracted. 256 preferred terms (PTs) of adverse reactions involving 27 system organ classes were identified. Significant AEs that were not reported on the drug label, such as 'dyspnea,' 'body temperature,' and 'tongue pruritus,' were reported. The median time to onset (TTO) of tezepelumab-related AEs was 35 days.The most frequent AEs in different sexes were 'arthralgia' and 'dyspnea,' with differences in signal strength ranking between the sexes.</p><p><strong>Conclusions: </strong>This study represents the largest report to date on tezepelumab-related AEs, providing valuable insights into the potential side effects of tezepelumab. This work is crucial for the broader clinical application of this novel biologic and improving outcomes for patients with severe asthma.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142461461","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}