Drug-Induced Anaphylaxis in a Vietnamese Pharmacovigilance Database: Trends and Specific Signals from a Disproportionality Analysis

Introduction Despite the numerous studies investigating drug-induced anaphylaxis (DIA), understanding and quantitative data analysis in developing countries remain limited. The aim of our study is to describe and quantify DIA using the National Pharmacovigilance Database of Vietnam (NPDV). Methods S...

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Veröffentlicht in:Drug safety 2019-05, Vol.42 (5), p.671-682
Hauptverfasser: Nguyen, Khac-Dung, Nguyen, Hoang-Anh, Vu, Dinh-Hoa, Le, Thi Thuy-Linh, Dang, Bich-Viet, Nguyen, Trung-Nguyen, Nguyen, Dang-Hoa, Nguyen, Thanh-Binh, Montastruc, Jean-Louis, Bagheri, Haleh
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Sprache:eng
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Zusammenfassung:Introduction Despite the numerous studies investigating drug-induced anaphylaxis (DIA), understanding and quantitative data analysis in developing countries remain limited. The aim of our study is to describe and quantify DIA using the National Pharmacovigilance Database of Vietnam (NPDV). Methods Spontaneous reporting of adverse drug reactions (ADRs) recorded between 2010 and 2016 were retrospectively analysed to identify DIA reports. The trend and characteristics of DIA cases were described. Multivariate disproportionality analysis was used for signal generation. Results Overall, 4873 DIA cases (13.2% of total ADRs) were recorded in the NPDV, 111 of which resulted in death (82% of total ADR-induced deaths) over a 7-year period. There was a remarkable increase in DIA reporting over time ( p  
ISSN:0114-5916
1179-1942
DOI:10.1007/s40264-018-0758-8