Korean J Med.
2017 Aug;92(4):392-400. 10.3904/kjm.2017.92.4.392.
Clinical Features of Serious Adverse Drug Reactions in a Tertiary Care Hospital in Korea
- Affiliations
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- 1Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea. parkjw@yuhs.ac
- 2Severance Hospital Regional Pharmacovigilance Center, Yonsei University College of Medicine, Seoul, Korea.
- KMID: 2392348
- DOI: http://doi.org/10.3904/kjm.2017.92.4.392
Abstract
- BACKGROUND/AIMS
Several studies have reported on the clinical aspects of adverse drug reactions (ADRs). To date, no study has evaluated serious adverse drug reactions (SADRs) in Korea. The current study evaluates the clinical expression of SADRs in a Korean hospital.
METHODS
We reviewed a total of 3,386 cases of SADR occurring between March 2012 and November 2015 in a single tertiary care institution (Regional Pharmacovigilance Center).
RESULTS
When classified by organ system, the most common SADRs were white cell and reticuloendothelial system disorders (n = 511). Skin/appendage (n = 296) and gastrointestinal (n = 216) disorders were the fourth- and eighth-most common SADRs, respectively. The three most common single symptoms were leukopenia (n = 499 events), hypotension (n = 444) and anaphylaxis (n = 215). Leukopenia was mainly caused by anti-tumor drugs, followed by piperacilin/tazobactam (n = 28), vancomycin (n = 10) and methimazole (n = 6). Hypotension was most often caused by propacetamol injection (n = 145), while anaphylaxis was mainly caused by cefaclor (n = 19), ranitidine (n = 12), iopamidol (n = 10) and multi-vitamin infusion (n = 9).
CONCLUSIONS
Significant differences were noted in the clinical aspects of ADRs and SADRs. Additional studies are warranted to further assess SADRs in response to frequently used causative drugs.
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