Allergy Asthma Respir Dis AARD Allergy, Asthma & Respiratory Disease 2288-0402 2288-0410 The Korean Academy of Pediatric Allergy and Respiratory Disease; The Korean Academy of Asthma, Allergy and Clinical Immunology 10.4168/aard.2020.8.1.30 Original Article Analysis of individual case safety reports of drug-induced anaphylaxis to the Korea Adverse Event Reporting System Cho Min Kyoung 1 Moon Mira 1 Kim Hyun Hwa 1 Kang Dong Yoon 1 Lee Ju-Yeun 2 Cho Sang-Heon 1 3 4 https://orcid.org/0000-0002-2317-4201 Kang Hye-Ryun 1 3 4 Drug Safety Monitoring Center, Seoul National University Hospital, Seoul, Korea. College of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National University, Seoul, Korea. Institute of Allergy and Clinical Immunology, Seoul National University Medical Research Center, Seoul, Korea. Division of Allergy and Clinical Immunology, Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea. Correspondence to: Hye-Ryun Kang. Division of Allergy and Clinical Immunology, Department of Internal Medicine, Seoul National University College of Medicine, 101 Daehak-ro, Jongno-gu, Seoul 03080, Korea. Tel: +82-2-2072-0820, Fax: +82-2-742-3291, helenmed@snu.ac.kr 01 2020 31 01 2020 8 1 30 35 18 06 2019 01 10 2019 17 10 2019 © 2020 The Korean Academy of Pediatric Allergy and Respiratory Disease; The Korean Academy of Asthma, Allergy and Clinical Immunology 2020 The Korean Academy of Pediatric Allergy and Respiratory Disease; The Korean Academy of Asthma, Allergy and Clinical Immunology This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/). Purpose

To identify causative agents of the drug-induced anaphylaxis (DIA) by using the Korea Institute of Drug Safety & Risk Management-Korea Adverse Event Reporting System (KIDS-KAERS) database (Ministry of Food and Drug Safety) in Korea and to check their labeling information regarding anaphylaxis.

 Methods

Among Individual Case Safety Reports from January, 2008 to December 2017, cases of DIA were analyzed for demographics, causative agents and fatal cases resulting in death. The domestic drug labeling, Micromedex and U.S. Food and Drug Administration (FDA) drug package insert, were reviewed to check if the labeling information on suspected causative agents contains anaphylaxis.

 Results

A total of 4,700 cases of DIA were analyzed. The mean age was 49.85±18.32 years, and 2,642 patients (56.2%) were females. Among 8,664 drugs reported as causative agents, antibiotics (27.4%) accounted for the largest portion. There were 18 fatal cases: antibiotics (7 cases), antineoplastic agents (4 cases) were the major causative drugs for the mortality cases. Of 513 drugs reported as suspected causative agents, 103 (20.1%) did not list anaphylaxis as an adverse effect on domestic drug labeling and 16 (3.1%) did not reflect anaphylaxis in any of 3 adverse drug information.

 Conclusion

Analysis of 10-year data showed that antibiotics were the main cause of DIA and the mortality rate was 0.7%. In 3.1% of suspected drugs, there was no description of anaphylaxis in any of the drug labeling.

 Drug-induced anaphylaxis Pharmacovigilance Drug labeling Mortality rate Ministry of Food and Drug Safety http://dx.doi.org/10.13039/501100003569

This research was supported by a grant from Ministry of Food and Drug Safety to the regional pharmacovigilance center in 2019.

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Values are presented as number (%) or mean±standard deviation.

 Categories of causative agents of drug-induced anaphylaxis (n=6,212)

NSAID, nonsteroidal anti-inflammatory drug.

 Causal agents of drug-induced anaphylaxis Causative agents of the anaphylaxis-related deaths

NSAID, nonsteroidal anti-inflammatory drug.

 List of drugs which list anaphylaxis as an adverse drug reaction on FDA drug label but not on domestic drug label

FDA, U.S. Food and Drug Administration.

 List of drugs which did not list anaphylaxis as an adverse drug reaction on domestic drug label, FDA drug label, and Micromedex

FDA, U.S. Food and Drug Administration; 5-HT4, 5-hydroxytryptamine 4; HMG, 3-hydroxy-methyl glutaryl; CoA, Coenzyme A