Jin An1, Heewon Jung2, Oh Young Kwon1, Yewon Kang1, Ji-Hyang Lee1, Ha-Kyeong Won1, Woo-Jung Song1, Hyouk-Soo Kwon1, You Sook Cho1, Hee-Bom Moon1, Tae-Bum Kim3. 1. Department of Allergy and Clinical Immunology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea; Pharmacovigilance Center, Asan Medical Center, Seoul, Korea. 2. Department of Allergy and Clinical Immunology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea; Department of Applied Statistics, Chung-Ang Graduate University, Seoul, Korea. 3. Department of Allergy and Clinical Immunology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea; Pharmacovigilance Center, Asan Medical Center, Seoul, Korea. Electronic address: tbkim@amc.seoul.kr.
Abstract
BACKGROUND: The various adverse drug reactions (ADRs) arise from different types of iodinated contrast media (ICM). OBJECTIVE: Thus, we investigated the occurrence rate and types of ADRs according to the total usage cases of the 7 most common ICM. METHODS: We retrospectively reviewed 74,242 causal ADRs caused by ICM from the Korea Adverse Event Reporting System database between January 2014 and December 2016. The 11,712,796 total usage cases that represent all administrations of ICM reported from individual medical institutions were received from the Health Insurance Review and Assessment Service. A proportionality test was used to examine the differences in the frequency ratio of causal ADRs to total usage cases. RESULTS: Immediate hypersensitivity (44,467 cases, 88.56%) occurred more frequently than delayed hypersensitivity (5,725 cases, 11.4%; P < .001). The overall occurrence rate of causal ADRs and serious ADRs considering total usage cases was 0.37% and 0.02%, respectively (P < .001). The ICM most commonly resulting in ADRs were iomeprol (0.7%) and iopromide (0.59%). The serious ADRs were most common for iomeprol (0.05%). When ADRs were classified according to the system organ class, "skin and appendages disorders" (47,065 cases, 63.4%) occurred most common. Iodixanol resulted in the highest frequency of "urinary system disorders." CONCLUSIONS: By comparison of the ADRs considering total usage cases, the incidence and classification of ADRs were different for each contrast medium. A prospective study is needed because the differences in these 7 major contrast media may assist in the selection of ICM tailored for each patient.
BACKGROUND: The various adverse drug reactions (ADRs) arise from different types of iodinated contrast media (ICM). OBJECTIVE: Thus, we investigated the occurrence rate and types of ADRs according to the total usage cases of the 7 most common ICM. METHODS: We retrospectively reviewed 74,242 causal ADRs caused by ICM from the Korea Adverse Event Reporting System database between January 2014 and December 2016. The 11,712,796 total usage cases that represent all administrations of ICM reported from individual medical institutions were received from the Health Insurance Review and Assessment Service. A proportionality test was used to examine the differences in the frequency ratio of causal ADRs to total usage cases. RESULTS: Immediate hypersensitivity (44,467 cases, 88.56%) occurred more frequently than delayed hypersensitivity (5,725 cases, 11.4%; P < .001). The overall occurrence rate of causal ADRs and serious ADRs considering total usage cases was 0.37% and 0.02%, respectively (P < .001). The ICM most commonly resulting in ADRs were iomeprol (0.7%) and iopromide (0.59%). The serious ADRs were most common for iomeprol (0.05%). When ADRs were classified according to the system organ class, "skin and appendages disorders" (47,065 cases, 63.4%) occurred most common. Iodixanol resulted in the highest frequency of "urinary system disorders." CONCLUSIONS: By comparison of the ADRs considering total usage cases, the incidence and classification of ADRs were different for each contrast medium. A prospective study is needed because the differences in these 7 major contrast media may assist in the selection of ICM tailored for each patient.
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Authors: Bernard Yu-Hor Thong; Michaela Lucas; Hye-Ryun Kang; Yoon-Seok Chang; Philip Hei Li; Min Moon Tang; James Yun; Jie Shen Fok; Byung-Keun Kim; Mizuho Nagao; Iris Rengganis; Yi-Giien Tsai; Wen-Hung Chung; Masao Yamaguchi; Ticha Rerkpattanapipat; Wasu Kamchaisatian; Ting Fan Leung; Ho Joo Yoon; Luo Zhang; Amir Hamzah Abdul Latiff; Takao Fujisawa; Francis Thien; Mariana C Castells; Pascal Demoly; Jiu-Yao Wang; Ruby Pawankar Journal: Asia Pac Allergy Date: 2020-01-30