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A study of the regional differences in propacetamol-related adverse events using VigiBase data of the World Health Organization

 Han Eol Jeong  ;  Sungho Bea  ;  Dongwon Yoon  ;  Juhong Jung  ;  Seung-Mok Park  ;  Juhee Jeon  ;  Young-Min Ye  ;  Jae-Hyun Lee  ;  Ju-Young Shin 
 SCIENTIFIC REPORTS, Vol.12(1) : 21568, 2022-12 
Journal Title
Issue Date
Acetaminophen / adverse effects ; Anaphylaxis* / chemically induced ; Anaphylaxis* / epidemiology ; Databases, Factual ; Dermatitis, Contact* ; Eczema* ; Humans ; Pharmacovigilance ; 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 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.
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Lee, Jae Hyun(이재현) ORCID logo https://orcid.org/0000-0002-0760-0071
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