Cargando…
Second-Generation Cephalosporins-Associated Drug-Induced Liver Disease: A Study in VigiBase with a Focus on the Elderly
Background: The objective of this study was to characterize individual case safety reports (ICSRs) and adverse drug reactions (ADRs) related to second-generation cephalosporins and resulting in hepatobiliary disorders, in VigiBase, WHO global database. Methods: All second-generation cephalosporins h...
Autores principales: | , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2021
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8151124/ https://www.ncbi.nlm.nih.gov/pubmed/34067178 http://dx.doi.org/10.3390/ph14050441 |
_version_ | 1783698309797380096 |
---|---|
author | Sipos, Mariana Farcas, Andreea Leucuta, Daniel Corneliu Bucsa, Camelia Huruba, Madalina Mogosan, Cristina |
author_facet | Sipos, Mariana Farcas, Andreea Leucuta, Daniel Corneliu Bucsa, Camelia Huruba, Madalina Mogosan, Cristina |
author_sort | Sipos, Mariana |
collection | PubMed |
description | Background: The objective of this study was to characterize individual case safety reports (ICSRs) and adverse drug reactions (ADRs) related to second-generation cephalosporins and resulting in hepatobiliary disorders, in VigiBase, WHO global database. Methods: All second-generation cephalosporins hepatobiliary ADRs reported up to July 2019 were included. Characteristic of cephalosporins and ADRs, aside from disproportionality data were evaluated. Results: A total of 1343 ICSRs containing 1585 ADRs were analyzed. Cefuroxime was suspected to have caused hepatobiliary disorders in most cases—in 38% of adults and in 35% of elderly. Abnormal hepatic function was the most frequent ADR, followed by jaundice and hepatitis. For 49% of the ADRs reported in the elderly and 51% in the adult population, the outcome was favorable, with fatal outcome for 2% of the adults and 10% of the elderly. Higher proportional reporting ration (PRR) values were reported in the elderly for cefotetan-associated jaundice, cefuroxime-associated acute hepatitis and hepatitis cholestatic as well as for cefotiam and cefmetazole-associated liver disorder. Conclusion: Hepatobiliary ADRs were reported for 2nd generation cephalosporins, with over 50% of cases in adults, without gender differences. Cholestatic hepatitis was predominately reported in the elderly and this category was more prone to specific hepatic reactions. |
format | Online Article Text |
id | pubmed-8151124 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-81511242021-05-27 Second-Generation Cephalosporins-Associated Drug-Induced Liver Disease: A Study in VigiBase with a Focus on the Elderly Sipos, Mariana Farcas, Andreea Leucuta, Daniel Corneliu Bucsa, Camelia Huruba, Madalina Mogosan, Cristina Pharmaceuticals (Basel) Article Background: The objective of this study was to characterize individual case safety reports (ICSRs) and adverse drug reactions (ADRs) related to second-generation cephalosporins and resulting in hepatobiliary disorders, in VigiBase, WHO global database. Methods: All second-generation cephalosporins hepatobiliary ADRs reported up to July 2019 were included. Characteristic of cephalosporins and ADRs, aside from disproportionality data were evaluated. Results: A total of 1343 ICSRs containing 1585 ADRs were analyzed. Cefuroxime was suspected to have caused hepatobiliary disorders in most cases—in 38% of adults and in 35% of elderly. Abnormal hepatic function was the most frequent ADR, followed by jaundice and hepatitis. For 49% of the ADRs reported in the elderly and 51% in the adult population, the outcome was favorable, with fatal outcome for 2% of the adults and 10% of the elderly. Higher proportional reporting ration (PRR) values were reported in the elderly for cefotetan-associated jaundice, cefuroxime-associated acute hepatitis and hepatitis cholestatic as well as for cefotiam and cefmetazole-associated liver disorder. Conclusion: Hepatobiliary ADRs were reported for 2nd generation cephalosporins, with over 50% of cases in adults, without gender differences. Cholestatic hepatitis was predominately reported in the elderly and this category was more prone to specific hepatic reactions. MDPI 2021-05-07 /pmc/articles/PMC8151124/ /pubmed/34067178 http://dx.doi.org/10.3390/ph14050441 Text en © 2021 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Article Sipos, Mariana Farcas, Andreea Leucuta, Daniel Corneliu Bucsa, Camelia Huruba, Madalina Mogosan, Cristina Second-Generation Cephalosporins-Associated Drug-Induced Liver Disease: A Study in VigiBase with a Focus on the Elderly |
title | Second-Generation Cephalosporins-Associated Drug-Induced Liver Disease: A Study in VigiBase with a Focus on the Elderly |
title_full | Second-Generation Cephalosporins-Associated Drug-Induced Liver Disease: A Study in VigiBase with a Focus on the Elderly |
title_fullStr | Second-Generation Cephalosporins-Associated Drug-Induced Liver Disease: A Study in VigiBase with a Focus on the Elderly |
title_full_unstemmed | Second-Generation Cephalosporins-Associated Drug-Induced Liver Disease: A Study in VigiBase with a Focus on the Elderly |
title_short | Second-Generation Cephalosporins-Associated Drug-Induced Liver Disease: A Study in VigiBase with a Focus on the Elderly |
title_sort | second-generation cephalosporins-associated drug-induced liver disease: a study in vigibase with a focus on the elderly |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8151124/ https://www.ncbi.nlm.nih.gov/pubmed/34067178 http://dx.doi.org/10.3390/ph14050441 |
work_keys_str_mv | AT siposmariana secondgenerationcephalosporinsassociateddruginducedliverdiseaseastudyinvigibasewithafocusontheelderly AT farcasandreea secondgenerationcephalosporinsassociateddruginducedliverdiseaseastudyinvigibasewithafocusontheelderly AT leucutadanielcorneliu secondgenerationcephalosporinsassociateddruginducedliverdiseaseastudyinvigibasewithafocusontheelderly AT bucsacamelia secondgenerationcephalosporinsassociateddruginducedliverdiseaseastudyinvigibasewithafocusontheelderly AT hurubamadalina secondgenerationcephalosporinsassociateddruginducedliverdiseaseastudyinvigibasewithafocusontheelderly AT mogosancristina secondgenerationcephalosporinsassociateddruginducedliverdiseaseastudyinvigibasewithafocusontheelderly |