| アブストラクト | 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. |
|---|
| ジャーナル名 | Scientific reports |
|---|
| Pubmed追加日 | 2022/12/14 |
|---|
| 投稿者 | Jeong, Han Eol; Bea, Sungho; Yoon, Dongwon; Jung, Juhong; Park, Seung-Mok; Jeon, Juhee; Ye, Young-Min; Lee, Jae-Hyun; Shin, Ju-Young |
|---|
| 組織名 | School of Pharmacy, Sungkyunkwan University, 2066, Seobu-ro, Jangan-gu, Suwon,;Gyeonggi-do, 16419, South Korea.;Department of Biohealth Regulatory Science, Sungkyunkwan University, Suwon, South;Korea.;Yungjin Pharm, Seoul, South Korea.;Department of Allergy and Clinical Immunology, Ajou University School of;Medicine, Suwon, South Korea.;Divison of Allergy and Immunology, Department of Internal Medicine, Institute of;Allergy, Yonsei University College of Medicine, Seoul, South Korea.;Gyeonggi-do, 16419, South Korea. shin.jy@skku.edu.;Korea. shin.jy@skku.edu.;Samsung Advanced Institute for Health Sciences and Technology, Sungkyunkwan;University, Seoul, South Korea. shin.jy@skku.edu. |
|---|
| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/36513759/ |
|---|
