4020 Analysis of Individual Case Safety Reports of Drug-Induced Anaphylaxis Based on Korea Adverse Event Reporting System Database

Saturday, 17 October 2015
Hall D1 Foyer (Floor 3) (Coex Convention Center)

Kyung-Hwan Lim, MD , Department of Internal Medicine, The Armed Forces Capital Hospital, Seongnam, South Korea

Mingyu Kang, MD , Regional Pharmacovigilance Center, Chungbuk National University Hospital, Cheongju, South Korea

Ju-Young Kim, MD , Regional Pharmacovigilance Center, Seoul National University Hospital, Seoul, South Korea

Jae Woo Jung , Department of Internal Medicine, Chung-Ang University Hospital, Seoul, South Korea

Hyun Jeong Kim , Korea Institute of Drug Safety and Risk Management, Anyang, South Korea

Yeon-Ju Woo , Korea Institute of Drug Safety and Risk Management, Anyang, South Korea

Soo-Youn Jung , Korea Institute of Drug Safety and Risk Management, Anyang, South Korea

Hye-Ryun Kang, MD, PhD , Regional Pharmacovigilance Center, Seoul National University Hospital, Seoul, South Korea

Background: Anaphylaxis is a catastrophic systemic reaction and drugs are responsible for 20% to 40% of anaphylaxis. However, little is known about the characteristics of drug-induced anaphylaxis in Korea. The aim of this study is to investigate causal drugs and clinical features of the drug-induced anaphylaxis in Korean by using data from the adverse drug reaction (ADR) reporting system to the Korea Institute of Drug Safety & Risk Management (KIDS).

Methods: Among Individual Case Safety Reports (ICSRs) to KIDS from January, 1989 to June 2014, cases of drug-induced anaphylaxis were selected and age, gender, causative agents, and fatal cases resulting in death were analyzed.

Results: A total of 2,190 cases were identified. Male was 912 (41.6%) and mean age was 49.81 ± 18.40 years. Most common causal drug was antibiotics (576, 26.3%), followed by aspirin/non-steroidal anti-inflammatory drugs (NSAIDs) (390, 17.8%), contrast media (339, 15.5%), and anticancer drug (273, 10.7%). There were 25 fatal cases and antibiotics (8 cases) and contrast media (4 cases) were the two most common causative drug category. Of 186 drugs reported at least two times as suspected causative agents, 19 drugs (10.2%) did not reflect anaphylaxis in their drug labeling information.

Conclusions: Antibiotics, aspirin/NSAIDs, contrast media, and anticancer drugs were 71.3% of causative drugs among anaphylaxis ICSRs in Korea. Antibiotics and contrast media were also main causative agents responsible for fatal drug induced anaphylaxis.