Pub Date : 2020-07-01DOI: 10.1177/0069477020940974
J. Dill
Over a 6-month period, 36 people reported episodes of bleeding associated with the use of a falsified dietary supplement between April and July 2017. Based on an investigation conducted by the Public Health Department in Antioquia, Colombia, the supplement (Vitacerebrina) was identified as being the associated product, which contained warfarin, a nondeclared prescription anticoagulant ingredient on the label. The mean age of the case patients was 52.3 years (range: 15-8 years). Approximately one third of the patients were younger than 18 years of age. The majority were female (66.7%), with three quarters of them taking the supplement for 9 to 30 days. The most common symptoms were ecchymosis, hematuria, abdominal pain, and gingivorrhagia. All patients were hospitalized. On hospitalization, the majority (81%) had elevated coagulation tests (international normalized ratio). The median duration of the hospital stay was 6 days (range: 2-11 days). Most patients (67%) received either intravenous or oral vitamin K as treatment. No patient deaths were recorded. All patients recovered and were discharged in good clinical condition. The authors concluded that these patients developed hemorrhagic illness related to the inadvertent administration of warfarin, which was not listed as an ingredient in a falsified dietary supplement. Dietary Supplement [“Vitacerebrina”] Pena-Acevedo L et al (L Pena-Acevedo, LIME, IPS Universitaria Sede Prado, Cra. 51A # 62-42, 2nd Floor, Medellin, Antioquia, Colombia; e-mail: lina.pena@udea.edu.co) A counterfeit multivitamin product inducing severe bleeding disorders in humans. Clin Toxicol (Phila) 58:846–848 (Aug) 2020
{"title":"Reporting on Adverse Clinical Events","authors":"J. Dill","doi":"10.1177/0069477020940974","DOIUrl":"https://doi.org/10.1177/0069477020940974","url":null,"abstract":"Over a 6-month period, 36 people reported episodes of bleeding associated with the use of a falsified dietary supplement between April and July 2017. Based on an investigation conducted by the Public Health Department in Antioquia, Colombia, the supplement (Vitacerebrina) was identified as being the associated product, which contained warfarin, a nondeclared prescription anticoagulant ingredient on the label. The mean age of the case patients was 52.3 years (range: 15-8 years). Approximately one third of the patients were younger than 18 years of age. The majority were female (66.7%), with three quarters of them taking the supplement for 9 to 30 days. The most common symptoms were ecchymosis, hematuria, abdominal pain, and gingivorrhagia. All patients were hospitalized. On hospitalization, the majority (81%) had elevated coagulation tests (international normalized ratio). The median duration of the hospital stay was 6 days (range: 2-11 days). Most patients (67%) received either intravenous or oral vitamin K as treatment. No patient deaths were recorded. All patients recovered and were discharged in good clinical condition. The authors concluded that these patients developed hemorrhagic illness related to the inadvertent administration of warfarin, which was not listed as an ingredient in a falsified dietary supplement. Dietary Supplement [“Vitacerebrina”] Pena-Acevedo L et al (L Pena-Acevedo, LIME, IPS Universitaria Sede Prado, Cra. 51A # 62-42, 2nd Floor, Medellin, Antioquia, Colombia; e-mail: lina.pena@udea.edu.co) A counterfeit multivitamin product inducing severe bleeding disorders in humans. Clin Toxicol (Phila) 58:846–848 (Aug) 2020","PeriodicalId":102871,"journal":{"name":"Clin-Alert®","volume":"13 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"123163543","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 : 2020-06-01DOI: 10.1177/0069477020932561
J. Dill
A case/noncase disproportionality analysis report using data from VigiBase (1968-2016) evaluated the cases of sialorrhea associated with the use of antipsychotics. Cases of “salivary hypersecretion” were considered cases, and those with other adverse events were defined as noncases. A total of 1 169 254 drug-adverse drug reaction pairs from 425 304 unique Individual Case Safety Reports were identified. Sialorrhea was more frequently reported with clozapine (n = 2732 [1.1%]) compared with other antipsychotics (n = 2911 [0.31%]; reporting odds ratio = 3.60; 95% confidence interval = 3.41-3.79). In addition, sialorrhea was also reported relatively more often by consumers (reporting odds ratio = 19.8; 95% confidence interval = 15.1-25.9) compared with health care professionals (reporting odds ratio = 2.44; 95% confidence interval = 2.272.63). Based on the results of this disproportionality analysis report, the authors concluded that sialorrhea was reported almost 4 times more often with clozapine use than with other antipsychotic use and was reported 8 times more often by patients than by health care professionals. Clozapine [Clozapine] Man WH et al (ER Heerdink, Division of Pharmacoepidemiology and Clinical Pharmacology, Department of Pharmaceutical Sciences, Faculty of Science, Utrecht University, PO Box 80.082, 3508 TB Utrecht, Netherlands; e-mail: E.R.Heerdink@uu.nl) Reporting patterns of sialorrhea comparing users of clozapine to users of other antipsychotics: a disproportionality analysis using VigiBase. J Clin Psychopharmacol 40:283–286 (May) 2020
{"title":"Reporting on Adverse Clinical Events","authors":"J. Dill","doi":"10.1177/0069477020932561","DOIUrl":"https://doi.org/10.1177/0069477020932561","url":null,"abstract":"A case/noncase disproportionality analysis report using data from VigiBase (1968-2016) evaluated the cases of sialorrhea associated with the use of antipsychotics. Cases of “salivary hypersecretion” were considered cases, and those with other adverse events were defined as noncases. A total of 1 169 254 drug-adverse drug reaction pairs from 425 304 unique Individual Case Safety Reports were identified. Sialorrhea was more frequently reported with clozapine (n = 2732 [1.1%]) compared with other antipsychotics (n = 2911 [0.31%]; reporting odds ratio = 3.60; 95% confidence interval = 3.41-3.79). In addition, sialorrhea was also reported relatively more often by consumers (reporting odds ratio = 19.8; 95% confidence interval = 15.1-25.9) compared with health care professionals (reporting odds ratio = 2.44; 95% confidence interval = 2.272.63). Based on the results of this disproportionality analysis report, the authors concluded that sialorrhea was reported almost 4 times more often with clozapine use than with other antipsychotic use and was reported 8 times more often by patients than by health care professionals. Clozapine [Clozapine] Man WH et al (ER Heerdink, Division of Pharmacoepidemiology and Clinical Pharmacology, Department of Pharmaceutical Sciences, Faculty of Science, Utrecht University, PO Box 80.082, 3508 TB Utrecht, Netherlands; e-mail: E.R.Heerdink@uu.nl) Reporting patterns of sialorrhea comparing users of clozapine to users of other antipsychotics: a disproportionality analysis using VigiBase. J Clin Psychopharmacol 40:283–286 (May) 2020","PeriodicalId":102871,"journal":{"name":"Clin-Alert®","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"120944907","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 : 2020-05-01DOI: 10.1177/0069477020924640
J. Dill
A retrospective single-center cohort study compared the rates of nephrotoxicity in 300 patients who received continuous infusion or intermittent infusion vancomycin for at least 1 week in an outpatient parenteral antimicrobial therapy program. Nephrotoxicity was defined as an increase in serum creatinine greater than 0.5 mg/dL or a 50% increase from baseline for 2 consecutive measurements. Clinical failure was defined as unplanned readmission, extension of therapy, or change in antibiotics. Continuous infusion vancomycin was associated with a 3.22fold lower risk of nephrotoxicity when compared with intermittent infusion (odds ratio = 3.22, 95% confidence interval = 1.10-9.46, P = .027). In addition, there was a significantly slower onset to nephrotoxicity (P = .035). There was no difference between the groups for clinical failure rates (13.5% vs 23.0%; P = .147). The authors concluded that continuous infusion vancomycin was associated with a lower risk of and slower onset to nephrotoxicity than intermittent vancomycin infusion. There was no difference between the groups in clinical failure rates. Vancomycin [Vancomycin] Shakeraneh P et al (WD Kufel, Binghamton University School of Pharmacy and Pharmaceutical Sciences, PO Box 6000, Binghamton, NY 13902-6000; e-mail: wkufel@binghamton.edu) Nephrotoxicity risk and clinical effectiveness of continuous versus intermittent infusion vancomycin among patients in an outpatient parenteral antimicrobial therapy program. Pharmacotherapy 40:357–362 (Apr) 2020
一项回顾性单中心队列研究比较了300例在门诊静脉注射万古霉素治疗方案中连续输注或间歇输注万古霉素至少1周的患者肾毒性发生率。肾毒性定义为连续2次测定血清肌酐升高超过0.5 mg/dL或较基线升高50%。临床失败被定义为意外再入院、延长治疗或改变抗生素。与间歇输注万古霉素相比，持续输注万古霉素的肾毒性风险降低3.22倍(优势比= 3.22,95%可信区间= 1.10-9.46,P = 0.027)。此外，肾毒性发作明显较慢(P = 0.035)。两组临床失败率无差异(13.5% vs 23.0%;P = .147)。作者得出结论，持续输注万古霉素与间歇性输注万古霉素相比，发生肾毒性的风险更低，发作速度更慢。两组间临床失败率无差异。万古霉素[万古霉素]Shakeraneh P et al (WD Kufel，宾厄姆顿大学药学院，邮政信箱6000，宾厄姆顿，纽约州13902-6000;e-mail: wkufel@binghamton.edu)在门诊静脉外抗微生物治疗项目中，持续输注万古霉素与间歇输注万古霉素的肾毒性风险和临床效果。药物治疗40:357-362(四月)2020
{"title":"Reporting on Adverse Clinical Events","authors":"J. Dill","doi":"10.1177/0069477020924640","DOIUrl":"https://doi.org/10.1177/0069477020924640","url":null,"abstract":"A retrospective single-center cohort study compared the rates of nephrotoxicity in 300 patients who received continuous infusion or intermittent infusion vancomycin for at least 1 week in an outpatient parenteral antimicrobial therapy program. Nephrotoxicity was defined as an increase in serum creatinine greater than 0.5 mg/dL or a 50% increase from baseline for 2 consecutive measurements. Clinical failure was defined as unplanned readmission, extension of therapy, or change in antibiotics. Continuous infusion vancomycin was associated with a 3.22fold lower risk of nephrotoxicity when compared with intermittent infusion (odds ratio = 3.22, 95% confidence interval = 1.10-9.46, P = .027). In addition, there was a significantly slower onset to nephrotoxicity (P = .035). There was no difference between the groups for clinical failure rates (13.5% vs 23.0%; P = .147). The authors concluded that continuous infusion vancomycin was associated with a lower risk of and slower onset to nephrotoxicity than intermittent vancomycin infusion. There was no difference between the groups in clinical failure rates. Vancomycin [Vancomycin] Shakeraneh P et al (WD Kufel, Binghamton University School of Pharmacy and Pharmaceutical Sciences, PO Box 6000, Binghamton, NY 13902-6000; e-mail: wkufel@binghamton.edu) Nephrotoxicity risk and clinical effectiveness of continuous versus intermittent infusion vancomycin among patients in an outpatient parenteral antimicrobial therapy program. Pharmacotherapy 40:357–362 (Apr) 2020","PeriodicalId":102871,"journal":{"name":"Clin-Alert®","volume":"34 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"130666850","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 : 2020-04-01DOI: 10.1177/0069477020917938
J. Dill
Consequences related to Sophora secundiflora intentional abuse or intentional misuse were evaluated using data from 47 reports received by the Texas Poison Center Network during 2000 to 2018. The part of Sophora secundiflora most frequently involved in the ingestion was the seed (91.5%). Relatively few cases reported the ingestion of the flower (2.1%) or an unknown plant part (6.4%). Of the seed ingestion cases, the mean number of sees ingested was 1.7 (range =1-16 seeds) with the majority involving the ingestion of only one seed (82.9%). Fewer reports involved 2 seeds (11.4%), 6 seeds (2.9%), and 16 seeds (2.9%). Almost half of the patients (48.9%) were 13 to 19 years of age. Approximately one fifth (21.3%) were aged 12 years or less, and approximately one third (29.8%) were at least 20 years of age. The majority of patients were male (78.7%). The most frequently cited locations were the home (66%), school (17%), and public area (10.6%). Approximately one fifth were referred to a health care facility (19.1%). Slightly more than half (55.3%) of the cases reported symptoms, with the most frequently reported clinical effects including vomiting (34.0%), nausea (29.8%), and abdominal pain (21.3%). Based on this retrospective review of data from the Texas Poison Center Network, the authors concluded that approximately half of the cases of ingestion of Sophora secundiflora resulted in symptoms, predominantly gastrointestinal in nature. Sophora secundiflora [Sophora secundiflora, Texas Mountain Laurel] Forrester MB et al (MB Forrester, Independent Researcher, Austin, TX; e-mail: mathias.forrester@gmail.com) Abuse and misuse of Sophora secundiflora in Texas. Clin Toxicol (Phila) 58:302–303 (Apr) 2020
{"title":"Reporting on Adverse Clinical Events","authors":"J. Dill","doi":"10.1177/0069477020917938","DOIUrl":"https://doi.org/10.1177/0069477020917938","url":null,"abstract":"Consequences related to Sophora secundiflora intentional abuse or intentional misuse were evaluated using data from 47 reports received by the Texas Poison Center Network during 2000 to 2018. The part of Sophora secundiflora most frequently involved in the ingestion was the seed (91.5%). Relatively few cases reported the ingestion of the flower (2.1%) or an unknown plant part (6.4%). Of the seed ingestion cases, the mean number of sees ingested was 1.7 (range =1-16 seeds) with the majority involving the ingestion of only one seed (82.9%). Fewer reports involved 2 seeds (11.4%), 6 seeds (2.9%), and 16 seeds (2.9%). Almost half of the patients (48.9%) were 13 to 19 years of age. Approximately one fifth (21.3%) were aged 12 years or less, and approximately one third (29.8%) were at least 20 years of age. The majority of patients were male (78.7%). The most frequently cited locations were the home (66%), school (17%), and public area (10.6%). Approximately one fifth were referred to a health care facility (19.1%). Slightly more than half (55.3%) of the cases reported symptoms, with the most frequently reported clinical effects including vomiting (34.0%), nausea (29.8%), and abdominal pain (21.3%). Based on this retrospective review of data from the Texas Poison Center Network, the authors concluded that approximately half of the cases of ingestion of Sophora secundiflora resulted in symptoms, predominantly gastrointestinal in nature. Sophora secundiflora [Sophora secundiflora, Texas Mountain Laurel] Forrester MB et al (MB Forrester, Independent Researcher, Austin, TX; e-mail: mathias.forrester@gmail.com) Abuse and misuse of Sophora secundiflora in Texas. Clin Toxicol (Phila) 58:302–303 (Apr) 2020","PeriodicalId":102871,"journal":{"name":"Clin-Alert®","volume":"42 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"123159984","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 : 2020-02-01DOI: 10.1177/0069477020905315
J. Dill, T. Mcevoy
A 49-year-old female patient developed recurrent left painful parotid swelling and tenderness approximately 4 days after receiving the third of 4 cycles of 2-weekly dose-dense doxorubicin and cyclophosphamide chemotherapy for grade 3 invasive ductal carcinoma. No other medications were noted in this report. A physical examination on emergency room presentation revealed no fever and the absence of infective symptoms. An orthopantomogram ruled out the presence of parotid duct stones or other dental causes for her symptoms. Serological screenings for infectious etiologies were negative. The patient had also experienced temporary bilateral parotitis following the previous 2 cycles of this chemotherapy. She did not experience parotitis after the fourth cycle of chemotherapy. The authors concluded that this patient developed recurrent parotitis related to doxorubicin and cyclophosphamide therapy based on the temporal relationship between the administration of the drugs and the appearance and resolution of symptoms, including a positive rechallenge. According to the Naranjo adverse event causality scale, this reaction was rated as probable in relation to therapy. They noted that this is the first case report of parotitis associated with the combined use of the drugs. Doxorubicin [“Doxorubicin”] Cyclophosphamide [“Cytoxan”] Fox-Lewis A et al (A Fox-Lewis, Department of Palliative Care, Waikato District Health Board, Pembroke Street, Private Bag 3200, Hamilton 3240, New Zealand; e-mail: afoxlewis@gmail.com) Doxorubicin and cyclophosphamide-induced parotitis: a case report. J Clin Pharm Ther 45:211–213 (Feb) 2020
{"title":"Reporting on Adverse Clinical Events","authors":"J. Dill, T. Mcevoy","doi":"10.1177/0069477020905315","DOIUrl":"https://doi.org/10.1177/0069477020905315","url":null,"abstract":"A 49-year-old female patient developed recurrent left painful parotid swelling and tenderness approximately 4 days after receiving the third of 4 cycles of 2-weekly dose-dense doxorubicin and cyclophosphamide chemotherapy for grade 3 invasive ductal carcinoma. No other medications were noted in this report. A physical examination on emergency room presentation revealed no fever and the absence of infective symptoms. An orthopantomogram ruled out the presence of parotid duct stones or other dental causes for her symptoms. Serological screenings for infectious etiologies were negative. The patient had also experienced temporary bilateral parotitis following the previous 2 cycles of this chemotherapy. She did not experience parotitis after the fourth cycle of chemotherapy. The authors concluded that this patient developed recurrent parotitis related to doxorubicin and cyclophosphamide therapy based on the temporal relationship between the administration of the drugs and the appearance and resolution of symptoms, including a positive rechallenge. According to the Naranjo adverse event causality scale, this reaction was rated as probable in relation to therapy. They noted that this is the first case report of parotitis associated with the combined use of the drugs. Doxorubicin [“Doxorubicin”] Cyclophosphamide [“Cytoxan”] Fox-Lewis A et al (A Fox-Lewis, Department of Palliative Care, Waikato District Health Board, Pembroke Street, Private Bag 3200, Hamilton 3240, New Zealand; e-mail: afoxlewis@gmail.com) Doxorubicin and cyclophosphamide-induced parotitis: a case report. J Clin Pharm Ther 45:211–213 (Feb) 2020","PeriodicalId":102871,"journal":{"name":"Clin-Alert®","volume":"62 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2020-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"124259996","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}
京公网安备 11010802042870号
京ICP备2023020795号-1
扫码关注我们
求助内容：
应助结果提醒方式：