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":" ","pages":"1-11"},"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":" ","pages":"1-12"},"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":" ","pages":"1-9"},"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":" ","pages":"1-6"},"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":" ","pages":"1-8"},"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":" ","pages":"1-8"},"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":" ","pages":"1"},"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":" ","pages":"1-10"},"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}
Pub Date : 2024-10-22DOI: 10.1080/14740338.2024.2419547
Chiara Guarini, Anna Natalizia Santoro, Assunta Melaccio, Laura Lanotte, Gennaro Gadaleta-Caldarola, Francesco Giuliani, Antonello Pinto, Palma Fedele
Introduction: Breast cancer (BC) remains a prevalent and challenging malignancy among women, with significant advancements in treatment strategies over the past decades. Traditional chemotherapy has been progressively supplemented by newer modalities, including Antibody-Drug Conjugates (ADCs), Immunotherapy (IO), and Targeted Therapies (TT). Despite these advancements, there remains a critical need for strategies that maintain efficacy while minimizing toxicity.
Areas covered: This review delves into metronomic chemotherapy (MC), a novel approach involving the frequent administration of low-dose chemotherapy without prolonged breaks. We explore MC's impact across various breast cancer subtypes, such as Estrogen Receptor-Positive (ER+), HER2-Positive, and Triple-Negative Breast Cancer (TNBC). The literature reviewed highlights MC's mechanisms, including its anti-angiogenic, immunomodulatory, and antiproliferative effects, and its potential to improve treatment tolerability and address drug resistance.
Expert opinion: MC represents a promising adjunct to existing therapies, particularly in advanced or resistant cases. Its unique dosing schedule could offer sustained antitumor activity with reduced toxicity, making it a viable option for long-term management. However, further research is warranted to establish optimal dosing regimens, identify predictive biomarkers, and delineate its role within combination treatment strategies. Clarifying these aspects could refine MC's application, potentially reshaping treatment paradigms and enhancing patient outcomes in breast cancer management.
导言:乳腺癌(BC)仍然是女性中普遍存在且极具挑战性的恶性肿瘤,在过去几十年中,治疗策略取得了重大进展。传统化疗逐渐得到了抗体药物共轭物(ADC)、免疫疗法(IO)和靶向疗法(TT)等新方法的补充。尽管取得了这些进展,但仍然迫切需要既能保持疗效又能最大限度降低毒性的策略:本综述深入探讨了节律化疗(MC),这是一种涉及频繁施用低剂量化疗而不延长化疗间歇期的新方法。我们探讨了MC对各种乳腺癌亚型的影响,如雌激素受体阳性(ER+)、HER2阳性和三阴性乳腺癌(TNBC)。综述的文献强调了MC的作用机制,包括其抗血管生成、免疫调节和抗增生作用,以及其改善治疗耐受性和解决耐药性问题的潜力:MC是现有疗法的一种很有前景的辅助疗法,尤其是在晚期或耐药病例中。其独特的给药方式可在降低毒性的同时提供持续的抗肿瘤活性,使其成为长期治疗的可行选择。不过,还需要进一步研究,以确定最佳给药方案、确定预测性生物标志物,并明确其在联合治疗策略中的作用。明确这些方面可以完善 MC 的应用,从而有可能重塑治疗范式,提高乳腺癌患者的治疗效果。
{"title":"Metronomic chemotherapy and breast cancer: a critical evaluation of its role in the new landscape of therapeutics.","authors":"Chiara Guarini, Anna Natalizia Santoro, Assunta Melaccio, Laura Lanotte, Gennaro Gadaleta-Caldarola, Francesco Giuliani, Antonello Pinto, Palma Fedele","doi":"10.1080/14740338.2024.2419547","DOIUrl":"10.1080/14740338.2024.2419547","url":null,"abstract":"<p><strong>Introduction: </strong>Breast cancer (BC) remains a prevalent and challenging malignancy among women, with significant advancements in treatment strategies over the past decades. Traditional chemotherapy has been progressively supplemented by newer modalities, including Antibody-Drug Conjugates (ADCs), Immunotherapy (IO), and Targeted Therapies (TT). Despite these advancements, there remains a critical need for strategies that maintain efficacy while minimizing toxicity.</p><p><strong>Areas covered: </strong>This review delves into metronomic chemotherapy (MC), a novel approach involving the frequent administration of low-dose chemotherapy without prolonged breaks. We explore MC's impact across various breast cancer subtypes, such as Estrogen Receptor-Positive (ER+), HER2-Positive, and Triple-Negative Breast Cancer (TNBC). The literature reviewed highlights MC's mechanisms, including its anti-angiogenic, immunomodulatory, and antiproliferative effects, and its potential to improve treatment tolerability and address drug resistance.</p><p><strong>Expert opinion: </strong>MC represents a promising adjunct to existing therapies, particularly in advanced or resistant cases. Its unique dosing schedule could offer sustained antitumor activity with reduced toxicity, making it a viable option for long-term management. However, further research is warranted to establish optimal dosing regimens, identify predictive biomarkers, and delineate its role within combination treatment strategies. Clarifying these aspects could refine MC's application, potentially reshaping treatment paradigms and enhancing patient outcomes in breast cancer management.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-8"},"PeriodicalIF":3.0,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142461469","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 : 2024-10-19DOI: 10.1080/14740338.2024.2416916
George Tsey Sabblah, Katja Taxis, Mahama Duwiejua, Seth Kwaku Seaneke, Eugène van Puijenbroek, Florence van Hunsel
Introduction: Patient engagement in pharmacovigilance (PEP) has been shown to improve information on adverse drug reactions (ADRs), which may not be found in reports from healthcare professionals. This review shows that there is paucity of information on PEP in lower-middle-income countries (LMICs), particularly Africa. It provides insights into PEP in high-income countries (HICs) compared with Africa to help identify the disparities and system challenges in Africa.
Areas covered: We discussed the impact of PEP in HICs in comparison with Africa and incorporated two case studies: PEP in Ghana and medication error reporting in Africa using a scoping review. Recommendations were made to improve medication safety in Africa based on the identified disparities and system challenges.
Expert opinion: PEP is at an early stage in LMICs, particularly in Africa, with limited information available regarding patients' contributions to the safety of medicines. There should be further research into patients' roles in pharmacovigilance accompanied by advocacy efforts with policymakers, the development of sustainable funding strategies, benchmarking against experienced pharmacovigilance centers, and the use of technology to improve patient reporting.
简介:事实证明,患者参与药物警戒 (PEP) 可以改善药物不良反应 (ADR) 的信息,而这些信息可能无法在医疗保健专业人员的报告中找到。本综述显示,在中低收入国家(LMIC),尤其是非洲,有关药物警戒的信息很少。与非洲相比,本综述对高收入国家(HICs)的 PEP 进行了深入探讨,以帮助确定非洲的差异和系统挑战:我们讨论了与非洲相比,PEP 在高收入国家/地区的影响,并纳入了两个案例研究:我们讨论了高收入国家与非洲的 PEP 影响,并纳入了两个案例研究:加纳的 PEP 和非洲的用药错误报告。根据已确定的差异和系统挑战,提出了改善非洲用药安全的建议:专家意见:PEP 在低收入与中等收入国家(尤其是非洲)尚处于早期阶段,有关患者对用药安全的贡献的信息十分有限。应进一步研究患者在药物警戒中的作用,同时向政策制定者进行宣传,制定可持续的资助战略,以经验丰富的药物警戒中心为基准,并利用技术改善患者的报告情况。
{"title":"Achieving patient engagement in pharmacovigilance: from high-income countries to lower and -middle-income countries with focus on Africa.","authors":"George Tsey Sabblah, Katja Taxis, Mahama Duwiejua, Seth Kwaku Seaneke, Eugène van Puijenbroek, Florence van Hunsel","doi":"10.1080/14740338.2024.2416916","DOIUrl":"https://doi.org/10.1080/14740338.2024.2416916","url":null,"abstract":"<p><strong>Introduction: </strong>Patient engagement in pharmacovigilance (PEP) has been shown to improve information on adverse drug reactions (ADRs), which may not be found in reports from healthcare professionals. This review shows that there is paucity of information on PEP in lower-middle-income countries (LMICs), particularly Africa. It provides insights into PEP in high-income countries (HICs) compared with Africa to help identify the disparities and system challenges in Africa.</p><p><strong>Areas covered: </strong>We discussed the impact of PEP in HICs in comparison with Africa and incorporated two case studies: PEP in Ghana and medication error reporting in Africa using a scoping review. Recommendations were made to improve medication safety in Africa based on the identified disparities and system challenges.</p><p><strong>Expert opinion: </strong>PEP is at an early stage in LMICs, particularly in Africa, with limited information available regarding patients' contributions to the safety of medicines. There should be further research into patients' roles in pharmacovigilance accompanied by advocacy efforts with policymakers, the development of sustainable funding strategies, benchmarking against experienced pharmacovigilance centers, and the use of technology to improve patient reporting.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-9"},"PeriodicalIF":3.0,"publicationDate":"2024-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142461460","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}