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Adverse drug reactions

Article information

J Korean Med Assoc. 2019;62(9):472-479
Publication date (electronic) : 2019 September 19
doi : https://doi.org/10.5124/jkma.2019.62.9.472
Min-Kyung Cho, MD1orcid_icon, Dong Yoon Kang, MD1orcid_icon, Hye-Ryun Kang, MD1,2,3orcid_icon
1Drug Safety Center, Seoul National University Hospital, Korea.
2Institute of Allergy and Clinical Immunology, Seoul National University Medical Research Center, Korea.
3Division of Allergy and Clinical Immunology, Seoul National University Hospital, Seoul, Korea.
Corresponding author: Hye-Ryun Kang. helenmed@snu.ac.kr
Received 2019 June 19; Accepted 2019 July 29.

Abstract

There are no drugs without the risk of potential adverse reactions. All pharmacologically active substances can cause adverse drug reactions (ADRs). This paper aims at introducing recent trends in pharmacosurveillance systems for ADRs, which can be broadly classified into type A and B reactions. Since type A reactions are associated with drug pharmacology, they are usually dose-dependent and predictable. Whereas, type B reactions occur in some susceptible individuals, regardless of the pharmacological action of drug. Drug hypersensitivity reactions are typical examples of type B reactions and are subclassified according to the underlying pathomechanism. Recent advancements in pharmacogenomics have enlightened the understanding of individual differences in drug efficacy and susceptibility to ADRs. Therefore, expectations for safe personalized medicines are higher than ever before. However, premarketing clinical trials are too small and too short to uncover rare but serious ADRs and detect long-standing ADRs. In the past, post-marketing surveillance systems mainly focused on passive ADR monitoring systems, based on spontaneous reports. Recently, the importance of active pharmacovigilance systems, which use big data, is growing with recent advancements in medical informatics. Thus, regarding ADRs, suspecting and detecting the causative drug using causality assessment based on data science may contribute to decrease suffering induced by ADRs.

Keywords: Drug-related side effects and adverse reactions; Pharmacovigilance; Adverse drug reaction reporting systems; Pharmacogenetics; Big data

Notes

Conflict of Interest

No potential conflict of interest relevant to this article was reported.

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Table 1

Classification of adverse drug reactions

Table 1

Adapted from Edwards IR et al. Lancet 2000;356:1255-1259 [6].

SSRI, serotonin-selective reuptake inhibitor.

Table 2

Classification of drug hypersensitivity reactions

Table 2

Adapted from Weiss ME et al. Clin Allergy 1988;18:515-540 [8].

SJS, Steven-Johnson syndrome; TEN, toxic epidermal necrosis; AGEP, acute generalized exanthematous pustulosis; DRESS, drug reaction with eosinophilia and systemic symptoms; DiHS, drug-induced hypersensitivity syndrome.

Table 3

World Health Organization-Uppsala Monitoring Center causality categories

Table 3

Adapted from Edwards IR et al. Lancet 2000;356:1255-1259 [6].