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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container_end_page 682
container_issue 5
container_start_page 671
container_title Drug safety
container_volume 42
creator Nguyen, Khac-Dung
Nguyen, Hoang-Anh
Vu, Dinh-Hoa
Le, Thi Thuy-Linh
Nguyen, Hoang-Anh
Dang, Bich-Viet
Nguyen, Trung-Nguyen
Nguyen, Dang-Hoa
Nguyen, Thanh-Binh
Montastruc, Jean-Louis
Bagheri, Haleh
description 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  
doi_str_mv 10.1007/s40264-018-0758-8
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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  &lt; 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.</description><identifier>ISSN: 0114-5916</identifier><identifier>EISSN: 1179-1942</identifier><identifier>DOI: 10.1007/s40264-018-0758-8</identifier><identifier>PMID: 30478823</identifier><language>eng</language><publisher>Cham: Springer International Publishing</publisher><subject>Adverse Drug Reaction Reporting Systems ; Allergies ; Amoxicillin ; Anaphylaxis ; Anaphylaxis - epidemiology ; Anesthetics ; Antibiotics ; Causality ; Cephalosporins ; Chymotrypsin ; Contrast agents ; Data analysis ; Databases, Factual ; Developing countries ; Drug Safety and Pharmacovigilance ; Drugs ; Epidemiology ; Humans ; Immunology ; LDCs ; Medicine ; Medicine &amp; Public Health ; Original Research Article ; Patients ; Pharmaceutical industry ; Pharmacology ; Pharmacology/Toxicology ; Pharmacovigilance ; Side effects ; Signal generation ; Studies ; Sulbactam ; Trends ; Vietnam - epidemiology</subject><ispartof>Drug safety, 2019-05, Vol.42 (5), p.671-682</ispartof><rights>Springer Nature Switzerland AG 2018</rights><rights>Copyright Springer Nature B.V. May 2019</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c372t-c7b98e7f16eb15c2726474a87a84783d4e881cca31241fc33eda0bb3c962ec4f3</citedby><cites>FETCH-LOGICAL-c372t-c7b98e7f16eb15c2726474a87a84783d4e881cca31241fc33eda0bb3c962ec4f3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s40264-018-0758-8$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s40264-018-0758-8$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27903,27904,41467,42536,51297</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30478823$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Nguyen, Khac-Dung</creatorcontrib><creatorcontrib>Nguyen, Hoang-Anh</creatorcontrib><creatorcontrib>Vu, Dinh-Hoa</creatorcontrib><creatorcontrib>Le, Thi Thuy-Linh</creatorcontrib><creatorcontrib>Nguyen, Hoang-Anh</creatorcontrib><creatorcontrib>Dang, Bich-Viet</creatorcontrib><creatorcontrib>Nguyen, Trung-Nguyen</creatorcontrib><creatorcontrib>Nguyen, Dang-Hoa</creatorcontrib><creatorcontrib>Nguyen, Thanh-Binh</creatorcontrib><creatorcontrib>Montastruc, Jean-Louis</creatorcontrib><creatorcontrib>Bagheri, Haleh</creatorcontrib><title>Drug-Induced Anaphylaxis in a Vietnamese Pharmacovigilance Database: Trends and Specific Signals from a Disproportionality Analysis</title><title>Drug safety</title><addtitle>Drug Saf</addtitle><addtitle>Drug Saf</addtitle><description>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  &lt; 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.</description><subject>Adverse Drug Reaction Reporting Systems</subject><subject>Allergies</subject><subject>Amoxicillin</subject><subject>Anaphylaxis</subject><subject>Anaphylaxis - epidemiology</subject><subject>Anesthetics</subject><subject>Antibiotics</subject><subject>Causality</subject><subject>Cephalosporins</subject><subject>Chymotrypsin</subject><subject>Contrast agents</subject><subject>Data analysis</subject><subject>Databases, Factual</subject><subject>Developing countries</subject><subject>Drug Safety and Pharmacovigilance</subject><subject>Drugs</subject><subject>Epidemiology</subject><subject>Humans</subject><subject>Immunology</subject><subject>LDCs</subject><subject>Medicine</subject><subject>Medicine &amp; Public Health</subject><subject>Original Research Article</subject><subject>Patients</subject><subject>Pharmaceutical industry</subject><subject>Pharmacology</subject><subject>Pharmacology/Toxicology</subject><subject>Pharmacovigilance</subject><subject>Side effects</subject><subject>Signal generation</subject><subject>Studies</subject><subject>Sulbactam</subject><subject>Trends</subject><subject>Vietnam - epidemiology</subject><issn>0114-5916</issn><issn>1179-1942</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNp1kE1r3DAQhkVpabZJf0AvRdCzWn2tJecWskkbCDSQj6sYy-ONwlp2JLt0z_nj0bJpc8ppYHjmnZmHkC-Cfxecmx9Zc1lpxoVl3Cwts-_IQghTM1Fr-Z4suBCaLWtRHZBPOT9wzq2s7EdyoLg21kq1IE-rNK_ZRWxnjy09iTDebzfwN2QaIgV6F3CK0GNGenUPqQc__AnrsIHoka5gggYyHtObhLHNFGJLr0f0oQueXod1hE2mXRr6krQKeUzDOKQpDKUfpu1u22abQz4iH7pC4ueXekhuz89uTn-xy98_L05PLplXRk7Mm6a2aDpRYSOWXpryu9FgDdjyjWo1Wiu8ByWkFp1XClvgTaN8XUn0ulOH5Ns-txzyOGOe3MMwp92RTsqKF5dc80KJPeXTkHPCzo0p9JC2TnC30-722l3R7nbanS0zX1-S56bH9v_EP88FkHugSAhxjel19dupz26vjxY</recordid><startdate>20190501</startdate><enddate>20190501</enddate><creator>Nguyen, Khac-Dung</creator><creator>Nguyen, Hoang-Anh</creator><creator>Vu, Dinh-Hoa</creator><creator>Le, Thi Thuy-Linh</creator><creator>Nguyen, Hoang-Anh</creator><creator>Dang, Bich-Viet</creator><creator>Nguyen, Trung-Nguyen</creator><creator>Nguyen, Dang-Hoa</creator><creator>Nguyen, Thanh-Binh</creator><creator>Montastruc, Jean-Louis</creator><creator>Bagheri, Haleh</creator><general>Springer International Publishing</general><general>Springer Nature B.V</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>4T-</scope><scope>7RV</scope><scope>7T2</scope><scope>7TK</scope><scope>7U7</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>C1K</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope></search><sort><creationdate>20190501</creationdate><title>Drug-Induced Anaphylaxis in a Vietnamese Pharmacovigilance Database: Trends and Specific Signals from a Disproportionality Analysis</title><author>Nguyen, Khac-Dung ; 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Medical Complete (Alumni)</collection><collection>Nursing &amp; Allied Health Database (Alumni Edition)</collection><collection>Health &amp; Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing &amp; Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><jtitle>Drug safety</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Nguyen, Khac-Dung</au><au>Nguyen, Hoang-Anh</au><au>Vu, Dinh-Hoa</au><au>Le, Thi Thuy-Linh</au><au>Nguyen, Hoang-Anh</au><au>Dang, Bich-Viet</au><au>Nguyen, Trung-Nguyen</au><au>Nguyen, Dang-Hoa</au><au>Nguyen, Thanh-Binh</au><au>Montastruc, Jean-Louis</au><au>Bagheri, Haleh</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Drug-Induced Anaphylaxis in a Vietnamese Pharmacovigilance Database: Trends and Specific Signals from a Disproportionality Analysis</atitle><jtitle>Drug safety</jtitle><stitle>Drug Saf</stitle><addtitle>Drug Saf</addtitle><date>2019-05-01</date><risdate>2019</risdate><volume>42</volume><issue>5</issue><spage>671</spage><epage>682</epage><pages>671-682</pages><issn>0114-5916</issn><eissn>1179-1942</eissn><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  &lt; 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.</abstract><cop>Cham</cop><pub>Springer International Publishing</pub><pmid>30478823</pmid><doi>10.1007/s40264-018-0758-8</doi><tpages>12</tpages></addata></record>
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subjects Adverse Drug Reaction Reporting Systems
Allergies
Amoxicillin
Anaphylaxis
Anaphylaxis - epidemiology
Anesthetics
Antibiotics
Causality
Cephalosporins
Chymotrypsin
Contrast agents
Data analysis
Databases, Factual
Developing countries
Drug Safety and Pharmacovigilance
Drugs
Epidemiology
Humans
Immunology
LDCs
Medicine
Medicine & Public Health
Original Research Article
Patients
Pharmaceutical industry
Pharmacology
Pharmacology/Toxicology
Pharmacovigilance
Side effects
Signal generation
Studies
Sulbactam
Trends
Vietnam - epidemiology
title Drug-Induced Anaphylaxis in a Vietnamese Pharmacovigilance Database: Trends and Specific Signals from a Disproportionality Analysis
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