Ann Dermatol.  2011 Nov;23(4):432-438.

Causality Assessment of Cutaneous Adverse Drug Reactions

• Son YM
• Lee JR
• Roh JY

Abstract

BACKGROUND
Cutaneous adverse drug reactions (ADRs) are the most common adverse reactions attributed to drugs. A systematic and effective approach to a patient with suspected drug eruption allows for prompt recognition, classification and treatment of cutaneous ADRs. A standardized and effective approach for objective causality assessment is necessary to make consistent and accurate identification of ADRs.
OBJECTIVE
Although the Naranjo algorithm is the most widely used assessment tool, it contains many components which are not suitable for clinical assessment of ADRs in Korea. The purpose of this study is to compare correlations of the Naranjo algorithm and the Korean algorithm to evaluate usefulness of both algorithms in order to make a causal link between drugs and cutaneous ADRs. In addition, this study classifies the clinical types and causative agents of cutaneous ADRs.
METHODS
The authors retrospectively reviewed the clinical types and laboratory findings of patients who were diagnosed with cutaneous ADRs in the dermatology clinic at Gil hospital. One hundred forty-one patients were enrolled in this evaluation. The causal relationship of ADRs was assessed by using the Naranjo algorithm and Korean algorithm (version 2.0).
RESULTS
A cross-tabulation analysis was applied to the Naranjo algorithm and Korean algorithm (version 2.0). Simple correlation analysis and a Bland-Altman plot were used for statistical analysis. Correlation analysis confirmed that the two assessment algorithms were significantly correlated. Exanthematous eruptions (68.8%), Stevens- Johnson syndrome (10.6%), and urticaria (8.5%) were the most common types of cutaneoues ADRs. The most common causative agents were antibiotics/antimicrobials, antipyretics/non-steroidal anti-inflammatory drugs, and central nervous system depressants.
CONCLUSION
The Naranjo algorithm and Korean algorithm (version 2.0) were significantly correlated with each other, and thus reliable assessment methods to determine cutaneous ADRs.

Keyword

Cutaneous adverse drug reactions; Korean algorithm; Naranjo algorithm

MeSH Terms

Aluminum Hydroxide
Carbonates
Central Nervous System
Dermatology
Drug Eruptions
Drug Toxicity
Humans
Korea
Retrospective Studies
Urticaria
Aluminum Hydroxide
Carbonates

Figure

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  Fig. 1 The measured quantity values of the Korean algorithm (version 2.0) in the x-axis and the Naranjo algorithm in the y-axis are significantly correlated.

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  Fig. 2 The x-axis indicates the average of the two values, and the y-axis indicates the difference of the two values, being diffuse sideward means there are many experimental variables. The up-and-down lines in the graph mean a +/-1 standard variation, and the more the measured quantity values are within the two lines, the higher the reliability.

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