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KMID : 1039620130030010050
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Korean Journal of Family Practice
2013 Volume.3 No. 1 p.50 ~ p.57
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Aspects of Serious Adverse Events from Spontaneous Report Data
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Jang Jung-Woo
Kim Woo-Sang
Sun Woo-Sung
Kim Young-Sik
Kim Hye-Kyung
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Abstract
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Background: The pharmacovigilance research network (PVRN) compiled cases of spontaneously reported adverse events (AEs) and analyzed patterns of serious AEs which have not been reported until now in Korea.
Methods: The data were obtained from the AEs which were reported to the PVRN of the Korea Food and Drug Administration. We analyzed the frequency rate by age group, sex, drug classes, organ systems, and symptoms. We performed analysis of 73 fatal AEs (life-threatening, death, and major disability) among serious AEs.
Results: Of the 52,459 AEs, 1,393 (2.7%) were serious AEs. Serious AEs were most frequently reported in subjects over 70 years of age (26.0%). Anti-infective agent was the most frequently reported drug class (18.7%). Skin was the most frequent (21.4%) system-organ class. Iopromide was the most frequently reported drug (3.6%), and skin eruption was the most common AE term (9.3%). Sulfamethoxazole and trimethoprim were the most frequently reported (0.4%) drugs in the fatal AEs.
Conclusion: According to spontaneously reported data, anti-infective agent and iopromide were the most frequently reported drug class and agent, respectively, and skin eruption was the most common AE term in serious AEs.
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KEYWORD
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Spontaneous Reporting, Serious Adverse Event
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