A study of the regional differences in propacetamol-related adverse events using VigiBase data of the World Health Organization
Abstract 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) ass...
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| Format: | Article |
| Language: | English |
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Nature Portfolio
2022-12-01
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| Series: | Scientific Reports |
| Online Access: | https://doi.org/10.1038/s41598-022-26211-0 |
| _version_ | 1797980390859735040 |
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| author | Han Eol Jeong Sungho Bea Dongwon Yoon Juhong Jung Seung-Mok Park Juhee Jeon Young-Min Ye Jae-Hyun Lee Ju-Young Shin |
| author_facet | Han Eol Jeong Sungho Bea Dongwon Yoon Juhong Jung Seung-Mok Park Juhee Jeon Young-Min Ye Jae-Hyun Lee Ju-Young Shin |
| author_sort | Han Eol Jeong |
| collection | DOAJ |
| description | Abstract 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; IC025 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; IC025 1.92) and contact dermatitis/eczema (rOR 16.73, 95% CI 12.48–22.42; IC025 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. |
| first_indexed | 2024-04-11T05:53:28Z |
| format | Article |
| id | doaj.art-bbfd4e5c4f8346c79d049d1e0bffee8b |
| institution | Directory Open Access Journal |
| issn | 2045-2322 |
| language | English |
| last_indexed | 2024-04-11T05:53:28Z |
| publishDate | 2022-12-01 |
| publisher | Nature Portfolio |
| record_format | Article |
| series | Scientific Reports |
| spelling | doaj.art-bbfd4e5c4f8346c79d049d1e0bffee8b2022-12-22T04:41:58ZengNature PortfolioScientific Reports2045-23222022-12-011211910.1038/s41598-022-26211-0A study of the regional differences in propacetamol-related adverse events using VigiBase data of the World Health OrganizationHan Eol Jeong0Sungho Bea1Dongwon Yoon2Juhong Jung3Seung-Mok Park4Juhee Jeon5Young-Min Ye6Jae-Hyun Lee7Ju-Young Shin8School of Pharmacy, Sungkyunkwan UniversitySchool of Pharmacy, Sungkyunkwan UniversitySchool of Pharmacy, Sungkyunkwan UniversityDepartment of Biohealth Regulatory Science, Sungkyunkwan UniversityYungjin PharmYungjin PharmDepartment of Allergy and Clinical Immunology, Ajou University School of MedicineDivison of Allergy and Immunology, Department of Internal Medicine, Institute of Allergy, Yonsei University College of MedicineSchool of Pharmacy, Sungkyunkwan UniversityAbstract 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; IC025 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; IC025 1.92) and contact dermatitis/eczema (rOR 16.73, 95% CI 12.48–22.42; IC025 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.https://doi.org/10.1038/s41598-022-26211-0 |
| spellingShingle | Han Eol Jeong Sungho Bea Dongwon Yoon Juhong Jung Seung-Mok Park Juhee Jeon Young-Min Ye Jae-Hyun Lee Ju-Young Shin A study of the regional differences in propacetamol-related adverse events using VigiBase data of the World Health Organization Scientific Reports |
| 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 |
| url | https://doi.org/10.1038/s41598-022-26211-0 |
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