Background: The Spontaneous Reporting System (SRS) of the Food and Drugs Administration (FDA) of the United States of America (US), known as the FDA Adverse Event Reporting System (FAERS), is a mechanism for collectin...Background: The Spontaneous Reporting System (SRS) of the Food and Drugs Administration (FDA) of the United States of America (US), known as the FDA Adverse Event Reporting System (FAERS), is a mechanism for collecting information on safety concerns associated with the use of drugs for redress, as they are used on large scale. The data which is the subject of this paper came from the FAERS database. This paper reports on the analysis of data covering 2013 to 2018 period, but compares the observed trends in the variables during this period with that of the 2007 to 2012 period to ascertain whether the trends change over time;as this paper is, in a sense, a sequel to an earlier one with a similar title as this but covering the period 2007 to 2012. Objectives: The objectives of the study reported in this paper were to: i) explore the trends in the variables involved with the adverse events problem in the 2013 to 2018 period and compare these trends with that found in the study covering the 2007 to 2012 period;ii) determine whether or not the level of missing variable values in the 2013 to 2018 period is lower than, the same or higher than it was in the 2007 to 2012 period;iii) find out how the first twenty principal suspect drugs most cited to be involved in adverse events occurring during drug use in the 2013 to 2018 period compare with that of the 2007 to 2012 period. Methods: The Food and Drugs Administration (FDA) makes extracts from the FAERS database freely available to the public on quarterly basis. Fourteen (14) out of over fifty (50) variables contained in these extracts were reckoned to be connected with the objectives of the study and were examined using the tools of frequencies, proportions and averages, on account of the nature of the data. Results: For the period 2013 to 2018, adverse events reports submitted to the FDA (US) more than doubled (2.1 times), accounting for an annual average growth rate of 15.8 %, which is considerably lower than the annual average growth rate of 22.1% for the 2007 to 2012 period. However, the reported number of cases for 2015 was 53.8% more than that of 2014. Consistent with the results for 2007 to 2012 period, the 2013 to 2018 period saw Female subjects accounting for over 60% of the annual and the overall number of reports. Overall, non-health professionals appear to have a slight edge over health professionals in reporting adverse drug events in the 2013 to 2018 period, with an indication that reports from non-health professionals are on the decline and that from health professionals is on the rise. Non-health professionals and health professionals were almost equally likely to report adverse events in the 2007 to 2012 period. Also, the findings for the 2013 to 2018 period suggest that the older one gets the more vulnerable one becomes to adverse events associated with drug use, which is consistent with the findings for the 2007 to 2012 period. Conclusion: The dangers that come with the use of drugs is an evolving one and therefore there is the need to examine SRS data from time to time so that emerging drug safety concerns can be dealt with timeously.展开更多
Background: α1-Adrenoceptor blockers (α1Bs) are used for the treatment of benign prostatic hyperplasia and hypertension, but they are known to cause hypotension-related adverse events. The objective of the present s...Background: α1-Adrenoceptor blockers (α1Bs) are used for the treatment of benign prostatic hyperplasia and hypertension, but they are known to cause hypotension-related adverse events. The objective of the present study was to evaluate the onset time profiles for syncope associated with the use of α1Bs. Methods: We analyzed the data obtained from?the Japanese Adverse Drug Event Report (JADER) database for a period from April 2004 until November 2016 and calculated reporting odds ratios (RORs) for eight α1Bs available on the Japanese market, using disproportionality analysis. Moreover, time information recorded in the JADER database was analyzed to evaluate the onset times of adverse events. Results: In total, 186,724 reports for males older than 20 years were analyzed. Significant RORs for syncope, with 95% confidence intervals, were obtained for naftopidil (2.53, 1.81 - 3.53), silodosin (4.24, 2.37 - 5.20), and tamsulosin (2.22, 1.75 - 2.81). The median onset times of syncope for naftopidil, silodosin, and tamsulosin were 37, 26, and 108 days, respectively. The shape parameters obtained by fitting the data for the three α1Bs to the Weibull distribution were all less than 1.0, indicating that all these drugs could be classified as the early failure type. The cumulative incidence rates showed that the onset times of syncope tended to be similar among the three α1Bs. Conclusions: Patients treated with selective α1Bs should be closely monitored for 100 days, especially in the first 20 to 40 days after initiation of silodosin or naftopidil. This information may be useful for patients and healthcare professionals in preventing syncope due to the use of selective α1Bs.展开更多
BACKGROUND Fractional flow reserve(FFR)measurement is commonly used in the cardiac catheterization laboratory to assess the functional significance of coronary arterial plaques.Robust real-world data on complications ...BACKGROUND Fractional flow reserve(FFR)measurement is commonly used in the cardiac catheterization laboratory to assess the functional significance of coronary arterial plaques.Robust real-world data on complications and modes of failure of FFR guidewires are limited.AIM To characterize these outcomes by analyzing the post-marketing surveillance data from the United States Food and Drug Administration Manufacturer and User Facility Device Experience(MAUDE)database for commonly used FFR guidewires.METHODS The MAUDE database was queried from January 2010 through April 2020 for 3 FFR guidewires[PressureWireTM X(Abbott),CometTM(Boston Scientific),and VerrataTM(Philips)]by searching for the following events:“Injury”,“malfunction”,“death”,and“other”.This yielded 544 reports.After excluding incomplete reports,486 reports were analyzed.RESULTS Guidewire tip fracture was the most commonly reported mode of failure,in 174(35.8%)cases followed by guidewire kinking(n=152,31.3%),communication failure(n=141,29.0%),and shaft fracture(n=67,13.8%).In total,133(27.4%)device failures resulted in patient adverse events.The most common adverse event was retained guidewire tip,in 71(53.4%)cases,followed by freshly deployed stent dislodgment(n=26,19.6%)and coronary artery dissection(n=23,17.3%).Seven deaths were reported.CONCLUSION FFR guidewire failures can occur because of various mechanisms and cause patient adverse events.The MAUDE database serves as an important platform for improved collaboration among clinicians,device manufacturers,and regulators to improve device performance and optimize patient outcomes.Our analysis provides mechanistic insights of FFR guidewire failure and associated adverse events but cannot verify causality or provide a comparison among different guidewires.展开更多
Objective In this study,we aimed to determine the incidence of adverse drug reactions(ADRs)of atezolizumab,identify ADR signals that are significantly related to atezolizumab,and provide a reference for the rational u...Objective In this study,we aimed to determine the incidence of adverse drug reactions(ADRs)of atezolizumab,identify ADR signals that are significantly related to atezolizumab,and provide a reference for the rational use of atezolizumab in the clinic through the statistical analysis of its adverse drug events(ADEs)reported in the American Food and Drug Administration(FDA)Adverse Event Reporting System(FAERS)database.Methods In total,4796 cases of atezolizumab ADEs reported in the American FAERS database from 2017 to 2019 were retrospectively analyzed.Results The top three ADEs were febrile neutropenia(3.7%),anemia(2.9%),and acute renal failure(2.3%).In addition,the incidence rates of some ADEs were significantly different according to sex and age.The systematic organ classification of atezolizumab ADEs involved 32 systems,among which the top three were blood and lymphatic system disorders(585 cases,12.2%),gastrointestinal disorders(433 cases,9.0%),and infections and infestations(401 cases,8.4%).The reporting odds ratio(ROR)method was used to detect the ADR signals of atezolizumab.The ROR(95%confidence interval)of the top ADE,febrile neutropenia,was 39.236(33.757–45.604).In addition,we found 121 cases of complications associated with immune-related ADEs.Conclusion The ADRs of atezolizumab reported in the FAERS database were consistent with those mentioned in the instructions for atezolizumab use,suggesting that atezolizumab has an acceptable and controllable drug effect.展开更多
目的基于FDA不良事件报告系统(FAERS)数据库,挖掘奥瑞利珠单抗的药品不良事件(adverse drug event,ADE)信号,为其临床合理安全使用提供参考。方法利用OpenVigil 2.1工具从FAERS数据库收集奥瑞利珠单抗的不良事件报告,筛选后采用比例报...目的基于FDA不良事件报告系统(FAERS)数据库,挖掘奥瑞利珠单抗的药品不良事件(adverse drug event,ADE)信号,为其临床合理安全使用提供参考。方法利用OpenVigil 2.1工具从FAERS数据库收集奥瑞利珠单抗的不良事件报告,筛选后采用比例报告比值法和报告比值比法对ADE信号进行挖掘,统计报告患者的性别、年龄、国别等基本信息,对新的ADE信号进行分析。结果以奥瑞利珠单抗为主要怀疑药物有17081份不良事件报告,女性占比较高(10363例,60.63%);年龄主要集中在40~65岁;上报年份主要集中在2022年和2023年;报告国家以美国和加拿大居多。共挖掘到ADE信号446个,涉及系统器官分类12个,主要集中在血液淋巴系统疾病、全身性疾病及给药部位各种反应、免疫系统疾病、感染及侵染性疾病和各类检查等方面。说明书尚未记录的ADE信号有白蛋白-球蛋白比率增加、脊柱磁共振成像异常、脑深核高信号、无张力膀胱和母体妊娠前暴露。结论所得ADE信号基本与说明书一致,脊柱磁共振成像异常提示脊柱可能存在病变,部分患者有可能因无张力膀胱,出现排尿困难的情况。妊娠期及哺乳期用药的安全性仍需进一步临床观察。展开更多
目的:评价和分析维泊妥珠单抗上市后的药物不良反应(adverse drug reaction,ADR)信号,为临床安全性管理提供参考。方法:通过开放性OpenVigil数据平台,收集2019年6月10日(美国FDA批准上市时间)至2023年3月31日美国FDA不良事件报告系统(FA...目的:评价和分析维泊妥珠单抗上市后的药物不良反应(adverse drug reaction,ADR)信号,为临床安全性管理提供参考。方法:通过开放性OpenVigil数据平台,收集2019年6月10日(美国FDA批准上市时间)至2023年3月31日美国FDA不良事件报告系统(FAERS)数据库中维泊妥珠单抗的ADR报告。采用比例失衡法中的报告比值比(ROR)和比例报告比(PRR)进行信号挖掘。为提高阈值,得到信号较强、较常出现的ADR,将信号进行二次筛选。结果:共检索到维泊妥珠单抗相关ADR报告2408份,经过二次筛选得到83个ADR信号。其中,脊柱磁共振成像异常、骨吸收增加、骨质溶解、天门冬氨酸氨基转移酶降低、丙氨酸氨基转移酶降低、低纤维蛋白原血症、肺栓塞等26个ADR信号在药品说明书中未提及。信号数或累积例数较多的系统器官分类包含感染及侵染类疾病(24个信号、632例),各类检查(17个信号、675例),血液及淋巴系统疾病(11个信号、734例),各类神经系统疾病(7个信号、153例),免疫系统疾病(3个信号、95例),全身性疾病及给药部位各种反应(2个信号、145例),代谢及营养类疾病(2个信号、87例)等。结论:除说明书提示的常见ADR外,本研究发现了维泊妥珠单抗新的ADR风险信号。建议临床在关注感染、骨髓抑制、周围神经病、输液相关反应、肝功能异常等已知常见ADR的同时,予以脊柱磁共振成像异常、骨吸收增加等新的风险信号更多关注。展开更多
文摘Background: The Spontaneous Reporting System (SRS) of the Food and Drugs Administration (FDA) of the United States of America (US), known as the FDA Adverse Event Reporting System (FAERS), is a mechanism for collecting information on safety concerns associated with the use of drugs for redress, as they are used on large scale. The data which is the subject of this paper came from the FAERS database. This paper reports on the analysis of data covering 2013 to 2018 period, but compares the observed trends in the variables during this period with that of the 2007 to 2012 period to ascertain whether the trends change over time;as this paper is, in a sense, a sequel to an earlier one with a similar title as this but covering the period 2007 to 2012. Objectives: The objectives of the study reported in this paper were to: i) explore the trends in the variables involved with the adverse events problem in the 2013 to 2018 period and compare these trends with that found in the study covering the 2007 to 2012 period;ii) determine whether or not the level of missing variable values in the 2013 to 2018 period is lower than, the same or higher than it was in the 2007 to 2012 period;iii) find out how the first twenty principal suspect drugs most cited to be involved in adverse events occurring during drug use in the 2013 to 2018 period compare with that of the 2007 to 2012 period. Methods: The Food and Drugs Administration (FDA) makes extracts from the FAERS database freely available to the public on quarterly basis. Fourteen (14) out of over fifty (50) variables contained in these extracts were reckoned to be connected with the objectives of the study and were examined using the tools of frequencies, proportions and averages, on account of the nature of the data. Results: For the period 2013 to 2018, adverse events reports submitted to the FDA (US) more than doubled (2.1 times), accounting for an annual average growth rate of 15.8 %, which is considerably lower than the annual average growth rate of 22.1% for the 2007 to 2012 period. However, the reported number of cases for 2015 was 53.8% more than that of 2014. Consistent with the results for 2007 to 2012 period, the 2013 to 2018 period saw Female subjects accounting for over 60% of the annual and the overall number of reports. Overall, non-health professionals appear to have a slight edge over health professionals in reporting adverse drug events in the 2013 to 2018 period, with an indication that reports from non-health professionals are on the decline and that from health professionals is on the rise. Non-health professionals and health professionals were almost equally likely to report adverse events in the 2007 to 2012 period. Also, the findings for the 2013 to 2018 period suggest that the older one gets the more vulnerable one becomes to adverse events associated with drug use, which is consistent with the findings for the 2007 to 2012 period. Conclusion: The dangers that come with the use of drugs is an evolving one and therefore there is the need to examine SRS data from time to time so that emerging drug safety concerns can be dealt with timeously.
文摘Background: α1-Adrenoceptor blockers (α1Bs) are used for the treatment of benign prostatic hyperplasia and hypertension, but they are known to cause hypotension-related adverse events. The objective of the present study was to evaluate the onset time profiles for syncope associated with the use of α1Bs. Methods: We analyzed the data obtained from?the Japanese Adverse Drug Event Report (JADER) database for a period from April 2004 until November 2016 and calculated reporting odds ratios (RORs) for eight α1Bs available on the Japanese market, using disproportionality analysis. Moreover, time information recorded in the JADER database was analyzed to evaluate the onset times of adverse events. Results: In total, 186,724 reports for males older than 20 years were analyzed. Significant RORs for syncope, with 95% confidence intervals, were obtained for naftopidil (2.53, 1.81 - 3.53), silodosin (4.24, 2.37 - 5.20), and tamsulosin (2.22, 1.75 - 2.81). The median onset times of syncope for naftopidil, silodosin, and tamsulosin were 37, 26, and 108 days, respectively. The shape parameters obtained by fitting the data for the three α1Bs to the Weibull distribution were all less than 1.0, indicating that all these drugs could be classified as the early failure type. The cumulative incidence rates showed that the onset times of syncope tended to be similar among the three α1Bs. Conclusions: Patients treated with selective α1Bs should be closely monitored for 100 days, especially in the first 20 to 40 days after initiation of silodosin or naftopidil. This information may be useful for patients and healthcare professionals in preventing syncope due to the use of selective α1Bs.
文摘BACKGROUND Fractional flow reserve(FFR)measurement is commonly used in the cardiac catheterization laboratory to assess the functional significance of coronary arterial plaques.Robust real-world data on complications and modes of failure of FFR guidewires are limited.AIM To characterize these outcomes by analyzing the post-marketing surveillance data from the United States Food and Drug Administration Manufacturer and User Facility Device Experience(MAUDE)database for commonly used FFR guidewires.METHODS The MAUDE database was queried from January 2010 through April 2020 for 3 FFR guidewires[PressureWireTM X(Abbott),CometTM(Boston Scientific),and VerrataTM(Philips)]by searching for the following events:“Injury”,“malfunction”,“death”,and“other”.This yielded 544 reports.After excluding incomplete reports,486 reports were analyzed.RESULTS Guidewire tip fracture was the most commonly reported mode of failure,in 174(35.8%)cases followed by guidewire kinking(n=152,31.3%),communication failure(n=141,29.0%),and shaft fracture(n=67,13.8%).In total,133(27.4%)device failures resulted in patient adverse events.The most common adverse event was retained guidewire tip,in 71(53.4%)cases,followed by freshly deployed stent dislodgment(n=26,19.6%)and coronary artery dissection(n=23,17.3%).Seven deaths were reported.CONCLUSION FFR guidewire failures can occur because of various mechanisms and cause patient adverse events.The MAUDE database serves as an important platform for improved collaboration among clinicians,device manufacturers,and regulators to improve device performance and optimize patient outcomes.Our analysis provides mechanistic insights of FFR guidewire failure and associated adverse events but cannot verify causality or provide a comparison among different guidewires.
文摘Objective In this study,we aimed to determine the incidence of adverse drug reactions(ADRs)of atezolizumab,identify ADR signals that are significantly related to atezolizumab,and provide a reference for the rational use of atezolizumab in the clinic through the statistical analysis of its adverse drug events(ADEs)reported in the American Food and Drug Administration(FDA)Adverse Event Reporting System(FAERS)database.Methods In total,4796 cases of atezolizumab ADEs reported in the American FAERS database from 2017 to 2019 were retrospectively analyzed.Results The top three ADEs were febrile neutropenia(3.7%),anemia(2.9%),and acute renal failure(2.3%).In addition,the incidence rates of some ADEs were significantly different according to sex and age.The systematic organ classification of atezolizumab ADEs involved 32 systems,among which the top three were blood and lymphatic system disorders(585 cases,12.2%),gastrointestinal disorders(433 cases,9.0%),and infections and infestations(401 cases,8.4%).The reporting odds ratio(ROR)method was used to detect the ADR signals of atezolizumab.The ROR(95%confidence interval)of the top ADE,febrile neutropenia,was 39.236(33.757–45.604).In addition,we found 121 cases of complications associated with immune-related ADEs.Conclusion The ADRs of atezolizumab reported in the FAERS database were consistent with those mentioned in the instructions for atezolizumab use,suggesting that atezolizumab has an acceptable and controllable drug effect.
文摘目的基于FDA不良事件报告系统(FAERS)数据库,挖掘奥瑞利珠单抗的药品不良事件(adverse drug event,ADE)信号,为其临床合理安全使用提供参考。方法利用OpenVigil 2.1工具从FAERS数据库收集奥瑞利珠单抗的不良事件报告,筛选后采用比例报告比值法和报告比值比法对ADE信号进行挖掘,统计报告患者的性别、年龄、国别等基本信息,对新的ADE信号进行分析。结果以奥瑞利珠单抗为主要怀疑药物有17081份不良事件报告,女性占比较高(10363例,60.63%);年龄主要集中在40~65岁;上报年份主要集中在2022年和2023年;报告国家以美国和加拿大居多。共挖掘到ADE信号446个,涉及系统器官分类12个,主要集中在血液淋巴系统疾病、全身性疾病及给药部位各种反应、免疫系统疾病、感染及侵染性疾病和各类检查等方面。说明书尚未记录的ADE信号有白蛋白-球蛋白比率增加、脊柱磁共振成像异常、脑深核高信号、无张力膀胱和母体妊娠前暴露。结论所得ADE信号基本与说明书一致,脊柱磁共振成像异常提示脊柱可能存在病变,部分患者有可能因无张力膀胱,出现排尿困难的情况。妊娠期及哺乳期用药的安全性仍需进一步临床观察。
文摘目的:评价和分析维泊妥珠单抗上市后的药物不良反应(adverse drug reaction,ADR)信号,为临床安全性管理提供参考。方法:通过开放性OpenVigil数据平台,收集2019年6月10日(美国FDA批准上市时间)至2023年3月31日美国FDA不良事件报告系统(FAERS)数据库中维泊妥珠单抗的ADR报告。采用比例失衡法中的报告比值比(ROR)和比例报告比(PRR)进行信号挖掘。为提高阈值,得到信号较强、较常出现的ADR,将信号进行二次筛选。结果:共检索到维泊妥珠单抗相关ADR报告2408份,经过二次筛选得到83个ADR信号。其中,脊柱磁共振成像异常、骨吸收增加、骨质溶解、天门冬氨酸氨基转移酶降低、丙氨酸氨基转移酶降低、低纤维蛋白原血症、肺栓塞等26个ADR信号在药品说明书中未提及。信号数或累积例数较多的系统器官分类包含感染及侵染类疾病(24个信号、632例),各类检查(17个信号、675例),血液及淋巴系统疾病(11个信号、734例),各类神经系统疾病(7个信号、153例),免疫系统疾病(3个信号、95例),全身性疾病及给药部位各种反应(2个信号、145例),代谢及营养类疾病(2个信号、87例)等。结论:除说明书提示的常见ADR外,本研究发现了维泊妥珠单抗新的ADR风险信号。建议临床在关注感染、骨髓抑制、周围神经病、输液相关反应、肝功能异常等已知常见ADR的同时,予以脊柱磁共振成像异常、骨吸收增加等新的风险信号更多关注。
