Khac-Dung Nguyen1,2, Hoang-Anh Nguyen1, Dinh-Hoa Vu1, Thi Thuy-Linh Le1, Hoang-Anh Nguyen1, Bich-Viet Dang1, Trung-Nguyen Nguyen3, Dang-Hoa Nguyen1, Thanh-Binh Nguyen4, Jean-Louis Montastruc2, Haleh Bagheri5. 1. The National Drug Information and Adverse Drug Reaction Monitoring Centre, Hanoi University of Pharmacy, Hanoi, Vietnam. 2. Laboratoire de Pharmacologie Médicale et Clinique, Faculté de Médecine de l'Université Paul-Sabatier (Medical and Clinical Pharmacology Laboratory, Faculty of Medicine, Paul-Sabatier University) and Centre Hospitalier Universitaire de Toulouse (Toulouse University Hospital Centre), Centre Midi-Pyrénées de PharmacoVigilance, de Pharmacoépidémiologie et d'Information sur le Médicament (Midi-Pyrenees Centre for Pharmacovigilance, Pharmacoepidemiology and Drug Information), UMR INSERM 1027, Toulouse, France. 3. Poison Control Centre, Bach Mai Hospital, Hanoi, Vietnam. 4. Department of Pharmacy Management and Pharmacoeconomics, Hanoi University of Pharmacy, Hanoi, Vietnam. 5. Laboratoire de Pharmacologie Médicale et Clinique, Faculté de Médecine de l'Université Paul-Sabatier (Medical and Clinical Pharmacology Laboratory, Faculty of Medicine, Paul-Sabatier University) and Centre Hospitalier Universitaire de Toulouse (Toulouse University Hospital Centre), Centre Midi-Pyrénées de PharmacoVigilance, de Pharmacoépidémiologie et d'Information sur le Médicament (Midi-Pyrenees Centre for Pharmacovigilance, Pharmacoepidemiology and Drug Information), UMR INSERM 1027, Toulouse, France. haleh.bagheri@univ-tlse3.fr.
Abstract
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 < 0.001). The incidence rates of DIA reporting per total ADRs and per 100,000 inhabitants remained high (mean rates [95% CI] of 12.06 [9.88-14.24] and 0.77 [0.33-1.20], respectively). Concerning suspected drugs, systemic antibiotics (n = 3318, 68%) were mostly reported with a reporting odds ratio (ROR) and 95% CI of 2.35 [2.20-2.51]. In the case of antibiotic-induced anaphylaxis, the third-generation cephalosporins were predominant (n = 1961, 40.2%, ROR 2.39 [2.24-2.55]). We also noted drugs generally associated with DIA such as contrast agents (ROR 2.43 [2.04-2.88]) and anaesthetics (ROR 4.02 [3.30-4.89]). Furthermore, unexpected signals were observed for alpha-chymotrypsin (ROR 1.75 [1.23-2.44]) and amoxicillin/sulbactam (ROR 1.59 [1.18-2.10]), uncommonly reported in western countries. CONCLUSION: In recent years, cases of drug-induced DIA have increased in Vietnam, mostly due to antibiotics and third-generation cephalosporins. The inappropriate use of these drugs should be taken into account. Our findings also highlighted typical Vietnamese signals for alpha-chymotrypsin- and amoxicillin/sulbactam-induced anaphylaxis, which may relate to a specific sociological context in resource-limited countries.
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 < 0.001). The incidence rates of DIA reporting per total ADRs and per 100,000 inhabitants remained high (mean rates [95% CI] of 12.06 [9.88-14.24] and 0.77 [0.33-1.20], respectively). Concerning suspected drugs, systemic antibiotics (n = 3318, 68%) were mostly reported with a reporting odds ratio (ROR) and 95% CI of 2.35 [2.20-2.51]. In the case of antibiotic-induced anaphylaxis, the third-generation cephalosporins were predominant (n = 1961, 40.2%, ROR 2.39 [2.24-2.55]). We also noted drugs generally associated with DIA such as contrast agents (ROR 2.43 [2.04-2.88]) and anaesthetics (ROR 4.02 [3.30-4.89]). Furthermore, unexpected signals were observed for alpha-chymotrypsin (ROR 1.75 [1.23-2.44]) and amoxicillin/sulbactam (ROR 1.59 [1.18-2.10]), uncommonly reported in western countries. CONCLUSION: In recent years, cases of drug-induced DIA have increased in Vietnam, mostly due to antibiotics and third-generation cephalosporins. The inappropriate use of these drugs should be taken into account. Our findings also highlighted typical Vietnamese signals for alpha-chymotrypsin- and amoxicillin/sulbactam-induced anaphylaxis, which may relate to a specific sociological context in resource-limited countries.
Authors: Maria Magdalena Tomasiak-Łozowska; Maciej Klimek; Agnieszka Lis; Marcin Moniuszko; Anna Bodzenta-Łukaszyk Journal: Adv Med Sci Date: 2018-03-20 Impact factor: 3.287
Authors: Kristina Juhlin; Ghazaleh Karimi; Maria Andér; Sara Camilli; Mukesh Dheda; Tan Siew Har; Rokiah Isahak; Su-Jung Lee; Sarah Vaughan; Pia Caduff; G Niklas Norén Journal: Drug Saf Date: 2015-04 Impact factor: 5.606