Cargando…
A study of the regional differences in propacetamol-related adverse events using VigiBase data of the World Health Organization
Upon withdrawal of propacetamol, an injectable formulation of the paracetamol prodrug, in Europe due to safety concerns, South Korea’s regulatory body requested a post-marketing surveillance study exploring its safety profile. We characterized regional disparities in adverse events (AE) associated w...
Autores principales: | , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Nature Publishing Group UK
2022
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9747950/ https://www.ncbi.nlm.nih.gov/pubmed/36513759 http://dx.doi.org/10.1038/s41598-022-26211-0 |
_version_ | 1784849718090661888 |
---|---|
author | Jeong, Han Eol Bea, Sungho Yoon, Dongwon Jung, Juhong Park, Seung-Mok Jeon, Juhee Ye, Young-Min Lee, Jae-Hyun Shin, Ju-Young |
author_facet | Jeong, Han Eol Bea, Sungho Yoon, Dongwon Jung, Juhong Park, Seung-Mok Jeon, Juhee Ye, Young-Min Lee, Jae-Hyun Shin, Ju-Young |
author_sort | Jeong, Han Eol |
collection | PubMed |
description | Upon withdrawal of propacetamol, an injectable formulation of the paracetamol prodrug, in Europe due to safety concerns, South Korea’s regulatory body requested a post-marketing surveillance study exploring its safety profile. We characterized regional disparities in adverse events (AE) associated with propacetamol between Asia and Europe using the World Health Organization’s pharmacovigilance database, VigiBase. We performed disproportionality analyses using reporting odds ratios (rOR) and information component (IC) to determine whether five AEs (anaphylaxis, Stevens–Johnson syndrome, thrombosis, contact dermatitis/eczema, injection site reaction [ISR]) were associated with propacetamol versus non-propacetamol injectable antipyretics in Asia and Europe, separately. In Asia, there was a high reporting ratio of propacetamol-related ISR (rOR 5.72, 95% CI 5.19–6.31; IC(025) 1.27), satisfying the signal criteria; there were no reports of thrombosis and contact dermatitis/eczema. Two signals were identified in Europe, with higher reporting ratios for thrombosis (rOR 7.45, 95% CI 5.19–10.71; IC(025) 1.92) and contact dermatitis/eczema (rOR 16.73, 95% CI 12.48–22.42; IC(025) 2.85). Reporting ratios of propacetamol-related anaphylaxis were low for Asia and Europe. While signals were found for thrombosis and contact dermatitis/eczema in Europe, these were not detected in Asia. These findings suggest potential ethnic differences in propacetamol-related AEs between Asia and Europe, which could serve as supportive data for future decision-making. |
format | Online Article Text |
id | pubmed-9747950 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Nature Publishing Group UK |
record_format | MEDLINE/PubMed |
spelling | pubmed-97479502022-12-15 A study of the regional differences in propacetamol-related adverse events using VigiBase data of the World Health Organization Jeong, Han Eol Bea, Sungho Yoon, Dongwon Jung, Juhong Park, Seung-Mok Jeon, Juhee Ye, Young-Min Lee, Jae-Hyun Shin, Ju-Young Sci Rep Article Upon withdrawal of propacetamol, an injectable formulation of the paracetamol prodrug, in Europe due to safety concerns, South Korea’s regulatory body requested a post-marketing surveillance study exploring its safety profile. We characterized regional disparities in adverse events (AE) associated with propacetamol between Asia and Europe using the World Health Organization’s pharmacovigilance database, VigiBase. We performed disproportionality analyses using reporting odds ratios (rOR) and information component (IC) to determine whether five AEs (anaphylaxis, Stevens–Johnson syndrome, thrombosis, contact dermatitis/eczema, injection site reaction [ISR]) were associated with propacetamol versus non-propacetamol injectable antipyretics in Asia and Europe, separately. In Asia, there was a high reporting ratio of propacetamol-related ISR (rOR 5.72, 95% CI 5.19–6.31; IC(025) 1.27), satisfying the signal criteria; there were no reports of thrombosis and contact dermatitis/eczema. Two signals were identified in Europe, with higher reporting ratios for thrombosis (rOR 7.45, 95% CI 5.19–10.71; IC(025) 1.92) and contact dermatitis/eczema (rOR 16.73, 95% CI 12.48–22.42; IC(025) 2.85). Reporting ratios of propacetamol-related anaphylaxis were low for Asia and Europe. While signals were found for thrombosis and contact dermatitis/eczema in Europe, these were not detected in Asia. These findings suggest potential ethnic differences in propacetamol-related AEs between Asia and Europe, which could serve as supportive data for future decision-making. Nature Publishing Group UK 2022-12-13 /pmc/articles/PMC9747950/ /pubmed/36513759 http://dx.doi.org/10.1038/s41598-022-26211-0 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . |
spellingShingle | Article Jeong, Han Eol Bea, Sungho Yoon, Dongwon Jung, Juhong Park, Seung-Mok Jeon, Juhee Ye, Young-Min Lee, Jae-Hyun Shin, Ju-Young A study of the regional differences in propacetamol-related adverse events using VigiBase data of the World Health Organization |
title | A study of the regional differences in propacetamol-related adverse events using VigiBase data of the World Health Organization |
title_full | A study of the regional differences in propacetamol-related adverse events using VigiBase data of the World Health Organization |
title_fullStr | A study of the regional differences in propacetamol-related adverse events using VigiBase data of the World Health Organization |
title_full_unstemmed | A study of the regional differences in propacetamol-related adverse events using VigiBase data of the World Health Organization |
title_short | A study of the regional differences in propacetamol-related adverse events using VigiBase data of the World Health Organization |
title_sort | study of the regional differences in propacetamol-related adverse events using vigibase data of the world health organization |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9747950/ https://www.ncbi.nlm.nih.gov/pubmed/36513759 http://dx.doi.org/10.1038/s41598-022-26211-0 |
work_keys_str_mv | AT jeonghaneol astudyoftheregionaldifferencesinpropacetamolrelatedadverseeventsusingvigibasedataoftheworldhealthorganization AT beasungho astudyoftheregionaldifferencesinpropacetamolrelatedadverseeventsusingvigibasedataoftheworldhealthorganization AT yoondongwon astudyoftheregionaldifferencesinpropacetamolrelatedadverseeventsusingvigibasedataoftheworldhealthorganization AT jungjuhong astudyoftheregionaldifferencesinpropacetamolrelatedadverseeventsusingvigibasedataoftheworldhealthorganization AT parkseungmok astudyoftheregionaldifferencesinpropacetamolrelatedadverseeventsusingvigibasedataoftheworldhealthorganization AT jeonjuhee astudyoftheregionaldifferencesinpropacetamolrelatedadverseeventsusingvigibasedataoftheworldhealthorganization AT yeyoungmin astudyoftheregionaldifferencesinpropacetamolrelatedadverseeventsusingvigibasedataoftheworldhealthorganization AT leejaehyun astudyoftheregionaldifferencesinpropacetamolrelatedadverseeventsusingvigibasedataoftheworldhealthorganization AT shinjuyoung astudyoftheregionaldifferencesinpropacetamolrelatedadverseeventsusingvigibasedataoftheworldhealthorganization AT jeonghaneol studyoftheregionaldifferencesinpropacetamolrelatedadverseeventsusingvigibasedataoftheworldhealthorganization AT beasungho studyoftheregionaldifferencesinpropacetamolrelatedadverseeventsusingvigibasedataoftheworldhealthorganization AT yoondongwon studyoftheregionaldifferencesinpropacetamolrelatedadverseeventsusingvigibasedataoftheworldhealthorganization AT jungjuhong studyoftheregionaldifferencesinpropacetamolrelatedadverseeventsusingvigibasedataoftheworldhealthorganization AT parkseungmok studyoftheregionaldifferencesinpropacetamolrelatedadverseeventsusingvigibasedataoftheworldhealthorganization AT jeonjuhee studyoftheregionaldifferencesinpropacetamolrelatedadverseeventsusingvigibasedataoftheworldhealthorganization AT yeyoungmin studyoftheregionaldifferencesinpropacetamolrelatedadverseeventsusingvigibasedataoftheworldhealthorganization AT leejaehyun studyoftheregionaldifferencesinpropacetamolrelatedadverseeventsusingvigibasedataoftheworldhealthorganization AT shinjuyoung studyoftheregionaldifferencesinpropacetamolrelatedadverseeventsusingvigibasedataoftheworldhealthorganization |