Pub Date : 2022-10-01DOI: 10.1097/FAD.0000000000000064
Henrik Horwitz, Rasmus Olsen, B. I. von Osmanski, E. J. Solem
Summary The current report briefly summarizes the experiences and statistics of the Adverse Drug Event Manager (ADEM) covering the Capital Region of Denmark, Denmark, during the period 1 January 2013 to 31 December 2020. During this 8-year period, the ADEM function has reported a total of 4262 adverse drug reactions (ADRs) to the Danish Medicines Agency, and of these, 141 had a fatal outcome (3.3%). The most commonly reported drugs were vaccines, antihypertensive agents, anticoagulants, and antiosteoporosis drugs. Fatal ADRs were predominantly related to anticoagulants. In 2020, the ADEM reported more than two-thirds of all ADRs for the Health Professionals in the Capital Region of Denmark. In addition to reporting ADRs, the ADEM has also had an extensive teaching and research activity and published a considerable number of studies on drug safety.
{"title":"Experiences from the adverse drug event manager","authors":"Henrik Horwitz, Rasmus Olsen, B. I. von Osmanski, E. J. Solem","doi":"10.1097/FAD.0000000000000064","DOIUrl":"https://doi.org/10.1097/FAD.0000000000000064","url":null,"abstract":"Summary The current report briefly summarizes the experiences and statistics of the Adverse Drug Event Manager (ADEM) covering the Capital Region of Denmark, Denmark, during the period 1 January 2013 to 31 December 2020. During this 8-year period, the ADEM function has reported a total of 4262 adverse drug reactions (ADRs) to the Danish Medicines Agency, and of these, 141 had a fatal outcome (3.3%). The most commonly reported drugs were vaccines, antihypertensive agents, anticoagulants, and antiosteoporosis drugs. Fatal ADRs were predominantly related to anticoagulants. In 2020, the ADEM reported more than two-thirds of all ADRs for the Health Professionals in the Capital Region of Denmark. In addition to reporting ADRs, the ADEM has also had an extensive teaching and research activity and published a considerable number of studies on drug safety.","PeriodicalId":39261,"journal":{"name":"Adverse Drug Reaction Bulletin","volume":"336 1","pages":"1304 - 1306"},"PeriodicalIF":0.0,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44844911","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 : 2022-08-01DOI: 10.1097/FAD.0000000000000063
D. Dalin, Nicoline E. Koch, O. Hilberg
Summary The Global Initiative for Asthma has since 2019 recommended as-needed inhaled steroids (ICS)/formoterol either alone or in combination with ICS/long-acting β2-agonists (LABA) maintenance for mild to moderate asthma. This might give patients more adverse effects by using LABA instead of short-acting β2-agonists (SABA) and by using ICS as needed where the patient might not be able to wash their mouth after use. The objective of this study is through a literature review to investigate whether the new recommendations increase the incidence of adverse events. We included 15 randomized clinical trials. They showed no increase in adverse events with as-needed ICS/formoterol only compared with either as-needed SABA only or maintenance ICS and SABA as-needed, and even a small tendency to less adverse events. When comparing as-needed and maintenance ICS/formoterol with as-needed SABA and maintenance ICS/LABA a small increase was seen for some adverse events, especially candidiasis (1.4 vs. 0.7%) and dysphonia (1.5 vs. 1.0%). In conclusion, the new treatment with as-needed ICS/formoterol only is at least as safe as the previously recommended treatment, regarding adverse effects. ICS/formoterol used as needed and maintenance might give an increased risk of candidiasis and dysphonia, though the absolute risk remains low.
{"title":"Will the new treatment recommendations for asthma increase adverse events?","authors":"D. Dalin, Nicoline E. Koch, O. Hilberg","doi":"10.1097/FAD.0000000000000063","DOIUrl":"https://doi.org/10.1097/FAD.0000000000000063","url":null,"abstract":"Summary The Global Initiative for Asthma has since 2019 recommended as-needed inhaled steroids (ICS)/formoterol either alone or in combination with ICS/long-acting β2-agonists (LABA) maintenance for mild to moderate asthma. This might give patients more adverse effects by using LABA instead of short-acting β2-agonists (SABA) and by using ICS as needed where the patient might not be able to wash their mouth after use. The objective of this study is through a literature review to investigate whether the new recommendations increase the incidence of adverse events. We included 15 randomized clinical trials. They showed no increase in adverse events with as-needed ICS/formoterol only compared with either as-needed SABA only or maintenance ICS and SABA as-needed, and even a small tendency to less adverse events. When comparing as-needed and maintenance ICS/formoterol with as-needed SABA and maintenance ICS/LABA a small increase was seen for some adverse events, especially candidiasis (1.4 vs. 0.7%) and dysphonia (1.5 vs. 1.0%). In conclusion, the new treatment with as-needed ICS/formoterol only is at least as safe as the previously recommended treatment, regarding adverse effects. ICS/formoterol used as needed and maintenance might give an increased risk of candidiasis and dysphonia, though the absolute risk remains low.","PeriodicalId":39261,"journal":{"name":"Adverse Drug Reaction Bulletin","volume":"335 1","pages":"1299 - 1302"},"PeriodicalIF":0.0,"publicationDate":"2022-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44948199","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 : 2022-06-01DOI: 10.1097/FAD.0000000000000062
A. Horwitz, H. Horwitz
Summary Drug-induced optic neuropathy is an understudied subject, and most of the evidence is based on case-reports. Amiodarone, ciprofloxacin, disulfiram, and sildenafil have been associated with optic neuropathy and their use is relatively prevalent. We therefore set out to investigate the strength of this association. In this nationwide cohort, we identified all incident users of the four drugs studied during the period 1 January 1999 to 31 December 2018. We then investigated their incidence of optic neuropathy in the year prior to prescription and in the year following We found that the risk of being diagnosed with optic neuropathy was 2.27 [95% confidence interval (1.29–4.00)] higher times during amiodarone therapy than in the year prior to prescription, but for the three other drugs we found no certain association. This study revealed a weak association between optic neuropathy and amiodarone; however, we were unable to confirm any association with ciprofloxacin, sildenafil, and disulfiram.
{"title":"Drug-induced optic neuropathy","authors":"A. Horwitz, H. Horwitz","doi":"10.1097/FAD.0000000000000062","DOIUrl":"https://doi.org/10.1097/FAD.0000000000000062","url":null,"abstract":"Summary Drug-induced optic neuropathy is an understudied subject, and most of the evidence is based on case-reports. Amiodarone, ciprofloxacin, disulfiram, and sildenafil have been associated with optic neuropathy and their use is relatively prevalent. We therefore set out to investigate the strength of this association. In this nationwide cohort, we identified all incident users of the four drugs studied during the period 1 January 1999 to 31 December 2018. We then investigated their incidence of optic neuropathy in the year prior to prescription and in the year following We found that the risk of being diagnosed with optic neuropathy was 2.27 [95% confidence interval (1.29–4.00)] higher times during amiodarone therapy than in the year prior to prescription, but for the three other drugs we found no certain association. This study revealed a weak association between optic neuropathy and amiodarone; however, we were unable to confirm any association with ciprofloxacin, sildenafil, and disulfiram.","PeriodicalId":39261,"journal":{"name":"Adverse Drug Reaction Bulletin","volume":"334 1","pages":"1295 - 1298"},"PeriodicalIF":0.0,"publicationDate":"2022-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43527223","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 : 2022-04-01DOI: 10.1097/fad.0000000000000061
N. Gogtay, Dhruve Soni, Sukant Pandit
{"title":"Medication-related osteonecrosis of the jaw – a scoping review","authors":"N. Gogtay, Dhruve Soni, Sukant Pandit","doi":"10.1097/fad.0000000000000061","DOIUrl":"https://doi.org/10.1097/fad.0000000000000061","url":null,"abstract":"","PeriodicalId":39261,"journal":{"name":"Adverse Drug Reaction Bulletin","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45134262","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 : 2022-02-01DOI: 10.1097/fad.0000000000000060
Marie Lund, B. Ejlertsen
{"title":"Cardiotoxicity in relation to treatment with aromatase inhibitors in breast cancer","authors":"Marie Lund, B. Ejlertsen","doi":"10.1097/fad.0000000000000060","DOIUrl":"https://doi.org/10.1097/fad.0000000000000060","url":null,"abstract":"","PeriodicalId":39261,"journal":{"name":"Adverse Drug Reaction Bulletin","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47183335","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 : 2021-11-18DOI: 10.1097/FAD.0000000000000058
P. Routledge, R. Bracchi
Summary Herbal medicines may cause adverse drug reactions (ADRs) due to effects of known constituent(s), substitution with other herbal ingredients, or contamination or adulteration with additional substances. Healthcare professionals (HCPs) should always take a full medicines history, including use of herbal medicines and other complementary products (e.g., food supplements and other dietary supplements). A range of resources are available to inform HCPs and the public/patients/ carers about possible ADRs associated with herbal medicines. HCPs and the public/patients also need to be made aware of the importance of reporting suspected ADRs to the appropriate regulatory agency. Good safety surveillance systems can thus help to ensure that those who choose to take herbal medicines are able to do so with acceptable safety.
{"title":"Adverse drug reactions to herbal medicines","authors":"P. Routledge, R. Bracchi","doi":"10.1097/FAD.0000000000000058","DOIUrl":"https://doi.org/10.1097/FAD.0000000000000058","url":null,"abstract":"Summary Herbal medicines may cause adverse drug reactions (ADRs) due to effects of known constituent(s), substitution with other herbal ingredients, or contamination or adulteration with additional substances. Healthcare professionals (HCPs) should always take a full medicines history, including use of herbal medicines and other complementary products (e.g., food supplements and other dietary supplements). A range of resources are available to inform HCPs and the public/patients/ carers about possible ADRs associated with herbal medicines. HCPs and the public/patients also need to be made aware of the importance of reporting suspected ADRs to the appropriate regulatory agency. Good safety surveillance systems can thus help to ensure that those who choose to take herbal medicines are able to do so with acceptable safety.","PeriodicalId":39261,"journal":{"name":"Adverse Drug Reaction Bulletin","volume":"331 1","pages":"1283 - 1286"},"PeriodicalIF":0.0,"publicationDate":"2021-11-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41793164","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 : 2021-09-15DOI: 10.1097/FAD.0000000000000057
Hans Kristian Råket Pedersen, A. Sørensen, A. B. Schelde, M. Nyeland, E. Jimenez‐Solem
Summary Previous studies on the prevalence of drug-drug interactions (DDIs) have largely been restricted to specific hospital departments. We identified common drug combinations and potential drug-drug interactions (pDDIs) in an entire hospital population throughout 1 year. Frequently administered drug combinations involved analgesics, cardiovascular medicines and gastrointestinal medicines. The prevalence of pDDIs among newly hospitalised patients was 2.6%. The most common pDDIs were ibuprofen – paracetamol, pantoprazole – paracetamol and morphine – paracetamol. Critical pDDIs were rare and only accounted for 0.4% of pDDIs.
{"title":"Prevalence and characteristics of drug-drug interactions among hospitalised patients in the Capital Region of Denmark","authors":"Hans Kristian Råket Pedersen, A. Sørensen, A. B. Schelde, M. Nyeland, E. Jimenez‐Solem","doi":"10.1097/FAD.0000000000000057","DOIUrl":"https://doi.org/10.1097/FAD.0000000000000057","url":null,"abstract":"Summary Previous studies on the prevalence of drug-drug interactions (DDIs) have largely been restricted to specific hospital departments. We identified common drug combinations and potential drug-drug interactions (pDDIs) in an entire hospital population throughout 1 year. Frequently administered drug combinations involved analgesics, cardiovascular medicines and gastrointestinal medicines. The prevalence of pDDIs among newly hospitalised patients was 2.6%. The most common pDDIs were ibuprofen – paracetamol, pantoprazole – paracetamol and morphine – paracetamol. Critical pDDIs were rare and only accounted for 0.4% of pDDIs.","PeriodicalId":39261,"journal":{"name":"Adverse Drug Reaction Bulletin","volume":"330 1","pages":"1279 - 1282"},"PeriodicalIF":0.0,"publicationDate":"2021-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43265875","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 : 2021-08-01DOI: 10.1097/FAD.0000000000000056
Niels August Willer Strand, S. Vinther, Henrik Horwitz
Summary In this paper, we critically review the information distributed to patients and doctors regarding adverse drug reactions. One major concern is that frequencies reported in the summary of product characteristics are not adjusted for the nocebo effect, leading to an exaggerated concern of adverse drug reactions. Previous research has found that the understanding of health hazards related to pharmacotherapy can be significantly improved by providing information on the frequencies of adverse drug reactions in both the active- and placebo-treated group.
{"title":"The rule of 3","authors":"Niels August Willer Strand, S. Vinther, Henrik Horwitz","doi":"10.1097/FAD.0000000000000056","DOIUrl":"https://doi.org/10.1097/FAD.0000000000000056","url":null,"abstract":"Summary In this paper, we critically review the information distributed to patients and doctors regarding adverse drug reactions. One major concern is that frequencies reported in the summary of product characteristics are not adjusted for the nocebo effect, leading to an exaggerated concern of adverse drug reactions. Previous research has found that the understanding of health hazards related to pharmacotherapy can be significantly improved by providing information on the frequencies of adverse drug reactions in both the active- and placebo-treated group.","PeriodicalId":39261,"journal":{"name":"Adverse Drug Reaction Bulletin","volume":"329 1","pages":"1275 - 1278"},"PeriodicalIF":0.0,"publicationDate":"2021-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48166550","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 : 2021-06-01DOI: 10.1097/FAD.0000000000000055
A. Eliasen, K. Schmiegelow, C. Rechnitzer, J. Brok, K. Dalhoff, R. Mathiasen
{"title":"Chemotherapy-induced nausea and vomiting in children – the missing evidence","authors":"A. Eliasen, K. Schmiegelow, C. Rechnitzer, J. Brok, K. Dalhoff, R. Mathiasen","doi":"10.1097/FAD.0000000000000055","DOIUrl":"https://doi.org/10.1097/FAD.0000000000000055","url":null,"abstract":"","PeriodicalId":39261,"journal":{"name":"Adverse Drug Reaction Bulletin","volume":"328 1","pages":"1271-1274"},"PeriodicalIF":0.0,"publicationDate":"2021-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47476569","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 : 2021-04-01DOI: 10.1097/FAD.0000000000000054
L. Hoegberg, Soeren Boegevig
{"title":"Adverse effects from selected antidotes commonly used in poisonings","authors":"L. Hoegberg, Soeren Boegevig","doi":"10.1097/FAD.0000000000000054","DOIUrl":"https://doi.org/10.1097/FAD.0000000000000054","url":null,"abstract":"","PeriodicalId":39261,"journal":{"name":"Adverse Drug Reaction Bulletin","volume":"327 1","pages":"1267-1270"},"PeriodicalIF":0.0,"publicationDate":"2021-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44987251","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：