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

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

doi:10.1007/s40264-018-0758-8

Cited by 18 publications

(28 citation statements)

References 50 publications

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“…Compared with our previous findings using the original case/non‐case method for the entire Vietnamese pharmacovigilance database, 5 the results of this study reinforced the major contribution of C3G subgroup to anaphylaxis and also evaluated the different risks of each drug in the same therapeutic subgroup. In fact, the lack of credibility in the risk assessment of the case/non‐case method originates from the challenge of choosing suitable non‐cases, which is similar to the controls in the case/control method.…”

Section: Discussionsupporting

confidence: 67%

“…In Vietnam, beta‐lactams, one of the most commonly‐used antibiotics, 18 were the main cause of ADRs according to NPDV data during the period 2010–2016 5 . The data on serious ADRs triggered by beta‐lactams (for example, anaphylaxis in this case) remain limited because drug use and prescription practices are different between countries.…”

Section: Discussionmentioning

confidence: 96%

“…In the study, when stratified by therapeutic area, the case numbers are well maintained. This approach also improves the “diluting” effect (over‐reporting of a specific group and/or under‐reporting of others) due to the high consumption of antibiotics (predominantly C3Gs) in Vietnam, 5 and it becomes closer to a case/control study. In addition, the population‐based exposure data of cephalosporins are not available to be included in the analysis.…”

Section: Discussionmentioning

confidence: 99%

“…There is still not enough known about beta‐lactam‐induced anaphylaxis, and there is a lack of quantitative data in developing regions. To our knowledge, anaphylaxis induced by the third generation of cephalosporins is relatively rare in western countries, 2,3 but it remains a common cause of anaphylaxis in developing countries 4,5 . The growing use of these drugs in recent decades means that an up‐to‐date and comprehensive assessment of the benefit/risk ratio is required.…”

Section: What Is Known and Objectivementioning

confidence: 99%

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Risk comparison of beta‐lactam‐induced anaphylaxis: Therapeutic stratification analysis in a Vietnamese pharmacovigilance database

Nguyen

et al. 2021

J Clin Pharm Ther

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What is known and objective There is limited data on the specific risks of anaphylaxis induced by beta‐lactam drugs. The aim of this study was to compare the risks of reporting beta‐lactam‐induced anaphylaxis using the national pharmacovigilance database of Vietnam (NPDV). Methods The multivariate generalised linear regression model was applied for signal generation and comparison of beta‐lactams. Results Between 2010 and 2016, there were 2,921 reports of anaphylaxis (19.93%) from 14,655 spontaneous reports of beta‐lactam use in the NDPV. Anaphylaxis signal generation was also found for the subgroup J01D (cephalosporins and carbapenems) (ROR = 1.27 [1.16‐1.39]) and beta‐lactamase‐sensitive penicillins (ROR = 1.74 [1.27‐2.35]). In the third generation cephalosporin subgroup, different risks were identified for the following combinations of beta‐lactams: 1) cefotaxime with cefoperazone+sulbactam; 2) cefixime/cefpodoxime/cefdinir with cefoperazone+sulbactam or ceftizoxime/cefoperazone/ceftazidime/ceftriaxone/cefotaxime. For the second generation cephalosporin subgroup, different risks were found for cefotiam compared to cefmetazole, cefaclor, cefamandole and cefuroxime. What is new and conclusion These findings identified and highlighted the different anaphylactic risks caused by various beta‐lactams in the main subgroups.

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Section: Discussionsupporting

confidence: 67%

Section: Discussionmentioning

confidence: 96%

Section: Discussionmentioning

confidence: 99%

Section: What Is Known and Objectivementioning

confidence: 99%

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Risk comparison of beta‐lactam‐induced anaphylaxis: Therapeutic stratification analysis in a Vietnamese pharmacovigilance database

Nguyen

et al. 2021

J Clin Pharm Ther

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“…However, these studies only descriptively analyzed the frequency of AEs and did not detect signals using statistical analysis. Some studies analyzed the cephalosporin-class adverse reactions (anaphylaxis, renal dysfunction, hepatic dysfunction, and Clostridium difficile infection) that have already been well-documented [ 11 , 12 , 13 , 14 , 15 ].…”

Section: Introductionmentioning

confidence: 99%

Signal Detection of Adverse Drug Reactions of Cephalosporins Using Data from a National Pharmacovigilance Database

Choi

Kim

et al. 2021

Pharmaceuticals

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This case-non-case study aims to detect signals not currently listed on cephalosporin drug labels. From 2009 to 2018, adverse event (AE) reports concerning antibacterial drugs (anatomical therapeutic chemical (ATC) code J01) in the Korea Adverse Events Reporting System (KAERS) database were examined. For signal detection, three indices of disproportionality, proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC), were calculated. The list of signals was compared with ADRs on the drug labels from the United States, United Kingdom, Japan, and South Korea. A total of 163,800 cephalosporin–AE combinations and 72,265 all other J01–AE combinations were analyzed. This study detected 472 signals and 114 new signals that are not included on the drug labels. Cefatrizine–corneal edema (PRR, 440.64; ROR, 481.67; IC, 3.84) and cefatrizine–corneal ulceration (PRR, 346.22; ROR, 399.70; IC, 4.40) had the highest PRR, ROR, and IC among all signals. Additionally, six serious AEs that were not listed on drug labels such as cefaclor-induced stupor (ten cases) and cefaclor-induced respiratory depression (four cases) were found. Detecting signals using a national pharmacovigilance database is useful for identifying unknown ADRs. This study identified signals of cephalosporins that warrant further investigation.

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Successful treatment of giant lymphatic malformation with symptomatic cutaneous vesicles by surgical excision and coverage with Integra®

et al. 2020

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

Cited by 18 publications

References 50 publications

Risk comparison of beta‐lactam‐induced anaphylaxis: Therapeutic stratification analysis in a Vietnamese pharmacovigilance database

Risk comparison of beta‐lactam‐induced anaphylaxis: Therapeutic stratification analysis in a Vietnamese pharmacovigilance database

Signal Detection of Adverse Drug Reactions of Cephalosporins Using Data from a National Pharmacovigilance Database

Successful treatment of giant lymphatic malformation with symptomatic cutaneous vesicles by surgical excision and coverage with Integra®

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