Pub Date : 2023-03-01DOI: 10.1177/00694770231160745
J. Dill, T. Mcevoy
In a prospective observational study, the incidence of adverse events was examined in 438 hemodialysis (HD) patients who received 3 doses of COVID-19 vaccines. Most patients included in the analysis received Oxford/AstraZeneca ChAdOx1 as the first 2 doses and Moderna mRNA1273 as the third dose. Overall, 79%, 50%, and 84% of the patients experienced at least 1 adverse event after the first, second, and third doses, respectively. Most reactions were minor and temporary. Compared with the first dose, the second dose was associated with a lower rate of adverse events and the third dose was associated with a higher rate of local injection site reactions but a lower rate of systemic effects. Further analysis indicated that characteristics associated with increased risk of adverse events included female sex (odds ratio [OR]: 2.82; 95% confidence interval [CI]: 1.90-4.18) and arteriovenous fistula access (OR: 1.73; 95% CI: 1.05-2.84). Based on the results of this prospective observational study in HD patients, the authors concluded that COVID-19 vaccination was generally well tolerated. Factors associated with increased risk of adverse events included female sex and arteriovenous fistula access. COVID Vaccine [ChAdOx1, mRNA-1273] Pai MF et al (Wan-Chuan Tsai: Division of Nephrology, Department of Internal Medicine; Center for General Education, Lee-Ming Institute of Technology, Far Eastern Memorial Hospital, No. 21, Section 2, Nanya South Road, Banciao District, New Taipei City 220, New Taipei City, Taiwan; e-mail: mkks618@gmail.com) Adverse events following the first, second and third doses of a COVID-19 vaccine in hemodialysis patients. Ren Fail 45:2172432 (Dec) 2023
{"title":"Reporting on Adverse Clinical Events","authors":"J. Dill, T. Mcevoy","doi":"10.1177/00694770231160745","DOIUrl":"https://doi.org/10.1177/00694770231160745","url":null,"abstract":"In a prospective observational study, the incidence of adverse events was examined in 438 hemodialysis (HD) patients who received 3 doses of COVID-19 vaccines. Most patients included in the analysis received Oxford/AstraZeneca ChAdOx1 as the first 2 doses and Moderna mRNA1273 as the third dose. Overall, 79%, 50%, and 84% of the patients experienced at least 1 adverse event after the first, second, and third doses, respectively. Most reactions were minor and temporary. Compared with the first dose, the second dose was associated with a lower rate of adverse events and the third dose was associated with a higher rate of local injection site reactions but a lower rate of systemic effects. Further analysis indicated that characteristics associated with increased risk of adverse events included female sex (odds ratio [OR]: 2.82; 95% confidence interval [CI]: 1.90-4.18) and arteriovenous fistula access (OR: 1.73; 95% CI: 1.05-2.84). Based on the results of this prospective observational study in HD patients, the authors concluded that COVID-19 vaccination was generally well tolerated. Factors associated with increased risk of adverse events included female sex and arteriovenous fistula access. COVID Vaccine [ChAdOx1, mRNA-1273] Pai MF et al (Wan-Chuan Tsai: Division of Nephrology, Department of Internal Medicine; Center for General Education, Lee-Ming Institute of Technology, Far Eastern Memorial Hospital, No. 21, Section 2, Nanya South Road, Banciao District, New Taipei City 220, New Taipei City, Taiwan; e-mail: mkks618@gmail.com) Adverse events following the first, second and third doses of a COVID-19 vaccine in hemodialysis patients. Ren Fail 45:2172432 (Dec) 2023","PeriodicalId":102871,"journal":{"name":"Clin-Alert®","volume":"69 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115870564","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-12-01DOI: 10.1177/00694770221143314
J. Dill, T. Mcevoy
A retrospective review was performed regarding the possible relationship between hearing disorders and the administration of the COVID vaccine. Data were used from the US Vaccine Adverse Event Reporting System (VAERS) between January 2020 and November 2021. A total of 14 956 and 151 reports of hearing-related adverse events were identified related to the COVID and influenza vaccines, respectively. The incidence of hearing disorder following COVID vaccination was 6.66/100 000. Further analysis revealed that reports of COVID vaccine–related hearing impairment was higher for both mRNA (reporting odds ratio [ROR] = 2.37, 95% confidence interval [CI] = 2.20-2.55) and virus vector vaccines (ROR = 2.50, 95% CI = 2.28-2.73). Reports of hearing dysfunction associated with the influenza vaccine were lower (ROR = 0.36, 95% CI = 0.30-0.42). Based on this retrospective review of VAERS database reports, the authors identified an increased risk for hearing disorder following administration of both mRNA and virus vector COVID vaccines compared with influenza vaccination. COVID Vaccine [COVID Vaccine] Chen C et al (Jie Xiao: Department of Pharmacy, Xiamen Cardiovascular Hospital of Xiamen University, 2999 Jinshan Road, Huli District, Xiamen, China; e-mail: yfxjbz666@163.com) Hearing disorder following COVID-19 vaccination: a pharmacovigilance analysis using the Vaccine Adverse Event Reporting System. J Clin Pharm Ther 47:1789–1795 (Nov) 2022
{"title":"Reporting on Adverse Clinical Events","authors":"J. Dill, T. Mcevoy","doi":"10.1177/00694770221143314","DOIUrl":"https://doi.org/10.1177/00694770221143314","url":null,"abstract":"A retrospective review was performed regarding the possible relationship between hearing disorders and the administration of the COVID vaccine. Data were used from the US Vaccine Adverse Event Reporting System (VAERS) between January 2020 and November 2021. A total of 14 956 and 151 reports of hearing-related adverse events were identified related to the COVID and influenza vaccines, respectively. The incidence of hearing disorder following COVID vaccination was 6.66/100 000. Further analysis revealed that reports of COVID vaccine–related hearing impairment was higher for both mRNA (reporting odds ratio [ROR] = 2.37, 95% confidence interval [CI] = 2.20-2.55) and virus vector vaccines (ROR = 2.50, 95% CI = 2.28-2.73). Reports of hearing dysfunction associated with the influenza vaccine were lower (ROR = 0.36, 95% CI = 0.30-0.42). Based on this retrospective review of VAERS database reports, the authors identified an increased risk for hearing disorder following administration of both mRNA and virus vector COVID vaccines compared with influenza vaccination. COVID Vaccine [COVID Vaccine] Chen C et al (Jie Xiao: Department of Pharmacy, Xiamen Cardiovascular Hospital of Xiamen University, 2999 Jinshan Road, Huli District, Xiamen, China; e-mail: yfxjbz666@163.com) Hearing disorder following COVID-19 vaccination: a pharmacovigilance analysis using the Vaccine Adverse Event Reporting System. J Clin Pharm Ther 47:1789–1795 (Nov) 2022","PeriodicalId":102871,"journal":{"name":"Clin-Alert®","volume":"23 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"133310776","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-11-01DOI: 10.1177/00694770221137544
J. Dill, T. Mcevoy
A 77-year-old male patient developed vitiligo on the arms and right leg approximately 2 years after the initiation of venetoclax (400 mg daily) for the management of chronic lymphocytic leukemia/small lymphocytic lymphoma. Previous therapy included ibrutinib (420 mg daily), which was discontinued due to the development of secondary systolic heart failure. Concurrent medications were not noted in the report. Initially, when venetoclax was started, the patient developed mild and self-limiting gastrointestinal side effects (eg, diarrhea and fatigue) that did not interfere with the continuation of therapy. After the development of vitiligo, venetoclax was suspected but therapy was continued; the patient was advised to use camouflage cosmetics and sunscreen. However, the vitiligo worsened, with new lesions developing 2 months later. Upon follow-up, the lesions have stabilized and the patient continues to respond to venetoclax therapy. The authors concluded that this patient developed vitiligo related to venetoclax therapy and noted that this is only the second published case report. Venetoclax [Venclexta] Abdeen M et al (Urwat Til Vusqa: Department of Internal Medicine, Allegheny Health Network, 320 E North Ave, Pittsburgh, PA 15212; e-mail: vusqa.urwat@ahn.org) Venetoclax-induced vitiligo in a patient with chronic lymphocytic leukemia. Anticancer Drugs 33:1167–1170 (Nov) 2022
一名77岁男性患者在开始使用venetoclax(每日400mg)治疗慢性淋巴细胞白血病/小淋巴细胞淋巴瘤约2年后，手臂和右腿出现白癜风。先前的治疗包括伊鲁替尼(每天420毫克)，由于继发性收缩期心力衰竭的发展而停止。报告中未注明同时使用的药物。最初，当venetoclax开始使用时，患者出现轻度和自限性胃肠道副作用(如腹泻和疲劳)，不影响治疗的继续。发展为白癜风后，怀疑有venetoclax，但仍继续治疗;医生建议患者使用伪装化妆品和防晒霜。然而，白癜风恶化，2个月后出现新的病变。在随访中，病变已经稳定，患者继续对venetoclax治疗有反应。作者得出结论，该患者与venetoclax治疗相关的白癜风，并指出这只是第二例发表的病例报告。Abdeen M等(Urwat Til Vusqa:内科，阿勒格尼卫生网络，320 E North Ave, Pittsburgh, PA 15212;e-mail: vusqa.urwat@ahn.org) venetoclax致慢性淋巴细胞白血病患者白癜风1例。抗癌药物33:1167-1170 (Nov) 2022
{"title":"Reporting on Adverse Clinical Events","authors":"J. Dill, T. Mcevoy","doi":"10.1177/00694770221137544","DOIUrl":"https://doi.org/10.1177/00694770221137544","url":null,"abstract":"A 77-year-old male patient developed vitiligo on the arms and right leg approximately 2 years after the initiation of venetoclax (400 mg daily) for the management of chronic lymphocytic leukemia/small lymphocytic lymphoma. Previous therapy included ibrutinib (420 mg daily), which was discontinued due to the development of secondary systolic heart failure. Concurrent medications were not noted in the report. Initially, when venetoclax was started, the patient developed mild and self-limiting gastrointestinal side effects (eg, diarrhea and fatigue) that did not interfere with the continuation of therapy. After the development of vitiligo, venetoclax was suspected but therapy was continued; the patient was advised to use camouflage cosmetics and sunscreen. However, the vitiligo worsened, with new lesions developing 2 months later. Upon follow-up, the lesions have stabilized and the patient continues to respond to venetoclax therapy. The authors concluded that this patient developed vitiligo related to venetoclax therapy and noted that this is only the second published case report. Venetoclax [Venclexta] Abdeen M et al (Urwat Til Vusqa: Department of Internal Medicine, Allegheny Health Network, 320 E North Ave, Pittsburgh, PA 15212; e-mail: vusqa.urwat@ahn.org) Venetoclax-induced vitiligo in a patient with chronic lymphocytic leukemia. Anticancer Drugs 33:1167–1170 (Nov) 2022","PeriodicalId":102871,"journal":{"name":"Clin-Alert®","volume":"78 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"130239899","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-10-01DOI: 10.1177/00694770221130635
J. Dill, T. Mcevoy
A retrospective review of data from the Japanese Adverse Drug Event Report (JADER) was performed to evaluate ocular adverse events reported with antineoplastics from April 2004 to April 2021. Eight types of ocular adverse events were included in the search: periorbital and eyelid, conjunctival, corneal, scleral, lacrimal, lens, retinal, and optic nerve disorders. Reporting odds ratios (RORs) were determined using these disorders. For periorbital and eyelid disorders, safety signals were detected only with imatinib mesilate (ROR = 4.61 [2.85-7.46]). For conjunctival disorders, safety signals were noted for imatinib mesilate (ROR = 3.14 [1.85-5.32]) and lapatinib tosilate hydrate (ROR = 6.13 [2.91-12.94]). Eight drugs were associated with increased RORs for corneal disorders, including S-1, erlotinib, capecitabine, cetuximab, gefitinib, vandetanib, trastuzumab emtansine, and lapatinib. No antineoplastics were associated with safety signals for scleral disorders. For lacrimal disorders, safety signals were detected with S-1 (ROR = 41.41 [34.62-49.53]) and pembrolizumab (ROR = 2.45 [1.44-4.16]). For lens disorders, several chemotherapy agents were associated with increased RORs, including lenalidomide, pomalidomide, elotuzumab, tamoxifen, bexarotene, and venetoclax. Further analysis revealed that some antineoplastics were associated with increased RORs based on sex and age. Based on the results of this retrospective analysis of data in the JADER database, the authors concluded that several anticancer drugs may be associated with increased safety signals for ocular adverse events, some of which were not readily recognized. The authors noted that these results may be helpful in predicting the occurrence of ocular adverse events by onclogists. Antineoplastics [Imatinib, Lapatinib, S-1, Erlotinib, Capecitabine, Cetuximab, Gefitinib, Vandetanib, Trastuzumab, Emtansine] Tanaka J et al (Takenao Koseki: Department of Clinical Pharmacy, Fujita Health University School of Medicine 1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192, Japan; e-mail: tkoseki@ fujita-hu.ac.jp) Analyses of ocular adverse reactions associated with anticancer drugs based on the Japanese pharmacovigilance database. Anticancer Res 42:4439–4451 (Sep) 2022
{"title":"Reporting on Adverse Clinical Events","authors":"J. Dill, T. Mcevoy","doi":"10.1177/00694770221130635","DOIUrl":"https://doi.org/10.1177/00694770221130635","url":null,"abstract":"A retrospective review of data from the Japanese Adverse Drug Event Report (JADER) was performed to evaluate ocular adverse events reported with antineoplastics from April 2004 to April 2021. Eight types of ocular adverse events were included in the search: periorbital and eyelid, conjunctival, corneal, scleral, lacrimal, lens, retinal, and optic nerve disorders. Reporting odds ratios (RORs) were determined using these disorders. For periorbital and eyelid disorders, safety signals were detected only with imatinib mesilate (ROR = 4.61 [2.85-7.46]). For conjunctival disorders, safety signals were noted for imatinib mesilate (ROR = 3.14 [1.85-5.32]) and lapatinib tosilate hydrate (ROR = 6.13 [2.91-12.94]). Eight drugs were associated with increased RORs for corneal disorders, including S-1, erlotinib, capecitabine, cetuximab, gefitinib, vandetanib, trastuzumab emtansine, and lapatinib. No antineoplastics were associated with safety signals for scleral disorders. For lacrimal disorders, safety signals were detected with S-1 (ROR = 41.41 [34.62-49.53]) and pembrolizumab (ROR = 2.45 [1.44-4.16]). For lens disorders, several chemotherapy agents were associated with increased RORs, including lenalidomide, pomalidomide, elotuzumab, tamoxifen, bexarotene, and venetoclax. Further analysis revealed that some antineoplastics were associated with increased RORs based on sex and age. Based on the results of this retrospective analysis of data in the JADER database, the authors concluded that several anticancer drugs may be associated with increased safety signals for ocular adverse events, some of which were not readily recognized. The authors noted that these results may be helpful in predicting the occurrence of ocular adverse events by onclogists. Antineoplastics [Imatinib, Lapatinib, S-1, Erlotinib, Capecitabine, Cetuximab, Gefitinib, Vandetanib, Trastuzumab, Emtansine] Tanaka J et al (Takenao Koseki: Department of Clinical Pharmacy, Fujita Health University School of Medicine 1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192, Japan; e-mail: tkoseki@ fujita-hu.ac.jp) Analyses of ocular adverse reactions associated with anticancer drugs based on the Japanese pharmacovigilance database. Anticancer Res 42:4439–4451 (Sep) 2022","PeriodicalId":102871,"journal":{"name":"Clin-Alert®","volume":"50 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"125394978","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-07-01DOI: 10.1177/00694770221111532
J. Dill, T. Mcevoy
A retrospective review of reports from the Food and Drug Administration Adverse Event Reporting System database was performed to evaluate the potential associations between the syndrome of inappropriate antidiuretic hormone secretion (SIADH) and various proton pump inhibitors (PPIs). Reports were extracted from the database from January 2004 to March 2020. The study identified a total of 273 reports of PPI-associated SIADH. The majority of cases were in elderly patients (71.1%). Women were more affected than men (48.7% vs. 41.8%). The highest reporting odds ratio (ROR) were reported with rabeprazole (ROR: 13.3, 95% CI = 7.2-24.9). The median time to SIADH onset was 22 (interquartile range: 6-692) days after PPI administration. PPI-associated SIADH was associated with a 2.95% fatality rate and a 79.7% hospitalization rate. The highest hospitalization death rate occurred in esomeprazole reports (91.2%). Based on the results of this retrospective review of reports received by the FDA database, the authors suggested that monitoring for SIADH in PPI users within the first months. IN addition, they suggested that larger epidemiological studies are warranted. Proton Pump Inhibitors [PPIs] Wang M et al (Jian Gong: Research Group of Jian Gong on Pharmacoepidemiology and Clinical Drug Evaluation, School of Life Science and Biopharmaceutics, Shenyang Pharmaceutical University, P.O. Box 88, No. 103 Wenhua Road, Shenyang 110016, P.R. China; e-mail: gongjian_1979@163.com) Syndrome of inappropriate antidiuretic hormone secretion is associated with different proton pump inhibitor use: a pharmacovigilance study. BMC Nephrol 23:191 (May) 2022
对美国食品和药物管理局不良事件报告系统数据库中的报告进行回顾性审查，以评估抗利尿激素分泌不当综合征(SIADH)与各种质子泵抑制剂(PPIs)之间的潜在关联。报告摘自2004年1月至2020年3月的数据库。该研究共发现273例与ppi相关的SIADH报告。以老年患者居多(71.1%)。女性比男性更容易受到影响(48.7%比41.8%)。雷贝拉唑的报告优势比(ROR)最高(ROR: 13.3, 95% CI = 7.2-24.9)。PPI给药后SIADH发作的中位时间为22天(四分位数范围:6-692)。ppi相关的SIADH死亡率为2.95%，住院率为79.7%。住院死亡率最高的是埃索美拉唑(91.2%)。基于FDA数据库收到的报告的回顾性审查结果，作者建议在PPI使用者的头几个月内监测SIADH。此外，他们还建议进行更大规模的流行病学研究。王敏等(剑功:沈阳药科大学生命科学与生物制药学院剑功药物流行病学与临床药物评价课程组，沈阳市文华路103号88号信箱110016;电子邮件:gongjian_1979@163.com)不适当的抗利尿激素分泌综合征与不同质子泵抑制剂的使用有关:一项药物警戒研究。中国生物医学工程学报(英文版)23 (5):2022
{"title":"Reporting on Adverse Clinical Events","authors":"J. Dill, T. Mcevoy","doi":"10.1177/00694770221111532","DOIUrl":"https://doi.org/10.1177/00694770221111532","url":null,"abstract":"A retrospective review of reports from the Food and Drug Administration Adverse Event Reporting System database was performed to evaluate the potential associations between the syndrome of inappropriate antidiuretic hormone secretion (SIADH) and various proton pump inhibitors (PPIs). Reports were extracted from the database from January 2004 to March 2020. The study identified a total of 273 reports of PPI-associated SIADH. The majority of cases were in elderly patients (71.1%). Women were more affected than men (48.7% vs. 41.8%). The highest reporting odds ratio (ROR) were reported with rabeprazole (ROR: 13.3, 95% CI = 7.2-24.9). The median time to SIADH onset was 22 (interquartile range: 6-692) days after PPI administration. PPI-associated SIADH was associated with a 2.95% fatality rate and a 79.7% hospitalization rate. The highest hospitalization death rate occurred in esomeprazole reports (91.2%). Based on the results of this retrospective review of reports received by the FDA database, the authors suggested that monitoring for SIADH in PPI users within the first months. IN addition, they suggested that larger epidemiological studies are warranted. Proton Pump Inhibitors [PPIs] Wang M et al (Jian Gong: Research Group of Jian Gong on Pharmacoepidemiology and Clinical Drug Evaluation, School of Life Science and Biopharmaceutics, Shenyang Pharmaceutical University, P.O. Box 88, No. 103 Wenhua Road, Shenyang 110016, P.R. China; e-mail: gongjian_1979@163.com) Syndrome of inappropriate antidiuretic hormone secretion is associated with different proton pump inhibitor use: a pharmacovigilance study. BMC Nephrol 23:191 (May) 2022","PeriodicalId":102871,"journal":{"name":"Clin-Alert®","volume":"8 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"116532996","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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