Major Aspects of Detection and Monitoring of Adverse Reactions Associated with Cephalosporin Antibiotic Treatment
Widespread use of cephalosporin antibiotics in clinical practice calls for greater attention to the risk of adverse drug reactions. Information on serious or unexpected adverse events reported during post-marketing experience is submitted to national and international pharmacovigilance databases. An...
Saved in:
| Main Authors: | , , , , , , , |
|---|---|
| Format: | Article |
| Language: | Russian |
| Published: |
Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»
2021-03-01
|
| Series: | Безопасность и риск фармакотерапии |
| Subjects: | |
| Online Access: | https://www.risksafety.ru/jour/article/view/216 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849343330437038080 |
|---|---|
| author | E. Yu. Demchenkova G. I. Gorodetskaya I. A. Mazerkina M. V. Zhuravleva A. S. Kazakov M. V. Gorodetskiy L. Yu. Badriddinova S. Yu. Serebrova |
| author_facet | E. Yu. Demchenkova G. I. Gorodetskaya I. A. Mazerkina M. V. Zhuravleva A. S. Kazakov M. V. Gorodetskiy L. Yu. Badriddinova S. Yu. Serebrova |
| author_sort | E. Yu. Demchenkova |
| collection | DOAJ |
| description | Widespread use of cephalosporin antibiotics in clinical practice calls for greater attention to the risk of adverse drug reactions. Information on serious or unexpected adverse events reported during post-marketing experience is submitted to national and international pharmacovigilance databases. Analysis of these reports helps to identify new adverse drug reactions.The aim of the study was to analyse the safety profile of cephalosporin antibiotics based on spontaneous reports in the international VigiBase database.Materials and methods: the analysis of the adverse reaction profile of cephalosporin antibiotics was based on MedDRA system organ classes and included spontaneous reports submitted to VigiBase from the moment of its creation until August 2020.Results: the authors identified the most clinically significant adverse reactions for different cephalosporin generations. They compared and analysed information on adverse events in VigiBase and in patient information leaflets of medicinal products authorised in the Russian Federation. It was demonstrated that some serious events described in VigiBase spontaneous reports for V-generation cephalosporins are not included in the “Side effects” section of the patient information leaflets. According to VigiBase, the use of ceftaroline was associated with the development of generalised exfoliative dermatitis, Stevens–Johnson syndrome, tubulointerstitial nephritis, while the use of ceftolozane was associated with acute kidney injury, renal insufficiency, sepsis, pneumonia, and respiratory insufficiency.Conclusion: reporting of unexpected and serious adverse drug reactions to cephalosporin antibiotics is an important task of healthcare practitioners. Availability of information on class-specific and generation-specific serious adverse reactions will help predict and prevent their development. |
| format | Article |
| id | doaj-art-ab77cd53a2b8429695f47ccbb7203f7e |
| institution | Kabale University |
| issn | 2312-7821 2619-1164 |
| language | Russian |
| publishDate | 2021-03-01 |
| publisher | Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» |
| record_format | Article |
| series | Безопасность и риск фармакотерапии |
| spelling | doaj-art-ab77cd53a2b8429695f47ccbb7203f7e2025-08-20T03:43:01ZrusMinistry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»Безопасность и риск фармакотерапии2312-78212619-11642021-03-0191344210.30895/2312-7821-2021-9-1-34-42183Major Aspects of Detection and Monitoring of Adverse Reactions Associated with Cephalosporin Antibiotic TreatmentE. Yu. Demchenkova0G. I. Gorodetskaya1I. A. Mazerkina2M. V. Zhuravleva3A. S. Kazakov4M. V. Gorodetskiy5L. Yu. Badriddinova6S. Yu. Serebrova7Scientific Centre for Expert Evaluation of Medicinal Products; I. M. Sechenov First Moscow State Medical UniversityScientific Centre for Expert Evaluation of Medicinal Products; I. M. Sechenov First Moscow State Medical UniversityScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal Products; I. M. Sechenov First Moscow State Medical UniversityScientific Centre for Expert Evaluation of Medicinal Products; Peoples’ Friendship University of RussiaPeoples’ Friendship University of RussiaI. M. Sechenov First Moscow State Medical UniversityScientific Centre for Expert Evaluation of Medicinal Products; I. M. Sechenov First Moscow State Medical UniversityWidespread use of cephalosporin antibiotics in clinical practice calls for greater attention to the risk of adverse drug reactions. Information on serious or unexpected adverse events reported during post-marketing experience is submitted to national and international pharmacovigilance databases. Analysis of these reports helps to identify new adverse drug reactions.The aim of the study was to analyse the safety profile of cephalosporin antibiotics based on spontaneous reports in the international VigiBase database.Materials and methods: the analysis of the adverse reaction profile of cephalosporin antibiotics was based on MedDRA system organ classes and included spontaneous reports submitted to VigiBase from the moment of its creation until August 2020.Results: the authors identified the most clinically significant adverse reactions for different cephalosporin generations. They compared and analysed information on adverse events in VigiBase and in patient information leaflets of medicinal products authorised in the Russian Federation. It was demonstrated that some serious events described in VigiBase spontaneous reports for V-generation cephalosporins are not included in the “Side effects” section of the patient information leaflets. According to VigiBase, the use of ceftaroline was associated with the development of generalised exfoliative dermatitis, Stevens–Johnson syndrome, tubulointerstitial nephritis, while the use of ceftolozane was associated with acute kidney injury, renal insufficiency, sepsis, pneumonia, and respiratory insufficiency.Conclusion: reporting of unexpected and serious adverse drug reactions to cephalosporin antibiotics is an important task of healthcare practitioners. Availability of information on class-specific and generation-specific serious adverse reactions will help predict and prevent their development.https://www.risksafety.ru/jour/article/view/216cephalosporinsadverse reactionsdrug safetydatabasespontaneous reportvigibasepharmacovigilance |
| spellingShingle | E. Yu. Demchenkova G. I. Gorodetskaya I. A. Mazerkina M. V. Zhuravleva A. S. Kazakov M. V. Gorodetskiy L. Yu. Badriddinova S. Yu. Serebrova Major Aspects of Detection and Monitoring of Adverse Reactions Associated with Cephalosporin Antibiotic Treatment Безопасность и риск фармакотерапии cephalosporins adverse reactions drug safety database spontaneous report vigibase pharmacovigilance |
| title | Major Aspects of Detection and Monitoring of Adverse Reactions Associated with Cephalosporin Antibiotic Treatment |
| title_full | Major Aspects of Detection and Monitoring of Adverse Reactions Associated with Cephalosporin Antibiotic Treatment |
| title_fullStr | Major Aspects of Detection and Monitoring of Adverse Reactions Associated with Cephalosporin Antibiotic Treatment |
| title_full_unstemmed | Major Aspects of Detection and Monitoring of Adverse Reactions Associated with Cephalosporin Antibiotic Treatment |
| title_short | Major Aspects of Detection and Monitoring of Adverse Reactions Associated with Cephalosporin Antibiotic Treatment |
| title_sort | major aspects of detection and monitoring of adverse reactions associated with cephalosporin antibiotic treatment |
| topic | cephalosporins adverse reactions drug safety database spontaneous report vigibase pharmacovigilance |
| url | https://www.risksafety.ru/jour/article/view/216 |
| work_keys_str_mv | AT eyudemchenkova majoraspectsofdetectionandmonitoringofadversereactionsassociatedwithcephalosporinantibiotictreatment AT gigorodetskaya majoraspectsofdetectionandmonitoringofadversereactionsassociatedwithcephalosporinantibiotictreatment AT iamazerkina majoraspectsofdetectionandmonitoringofadversereactionsassociatedwithcephalosporinantibiotictreatment AT mvzhuravleva majoraspectsofdetectionandmonitoringofadversereactionsassociatedwithcephalosporinantibiotictreatment AT askazakov majoraspectsofdetectionandmonitoringofadversereactionsassociatedwithcephalosporinantibiotictreatment AT mvgorodetskiy majoraspectsofdetectionandmonitoringofadversereactionsassociatedwithcephalosporinantibiotictreatment AT lyubadriddinova majoraspectsofdetectionandmonitoringofadversereactionsassociatedwithcephalosporinantibiotictreatment AT syuserebrova majoraspectsofdetectionandmonitoringofadversereactionsassociatedwithcephalosporinantibiotictreatment |