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Bae, Lee, Ha, Jeon, Moon, Choi, Baek, Cho, Choi, Cho, and Na: Adverse Drug Reactions to CT Contrast Media in South Korea: Incidence and Risk Factors
Contrast Media
Original Article

Journal of the Korean Society of Radiology 2016; 75(1): 41-48.

Published online: 1 July 2016

DOI: https://doi.org/10.3348/jksr.2016.75.1.41

Adverse Drug Reactions to CT Contrast Media in South Korea: Incidence and Risk Factors

Kyungsoo Bae, MD1, Sang Min Lee, MD2, Ji Young Ha, MD2, Kyung Nyeo Jeon, MD1, Jin Il Moon, MD1, Bo Hwa Choi, MD1, Hye Jin Baek, MD1, Soo Buem Cho, MD1, Dae Seob Choi, MD2, Jae Min Cho, MD2, Jae Beom Na, MD2

1Department of Radiology, Gyeongsang National University Changwon Hospital, Gyeongsang National University School of Medicine, Changwon, Korea.

2Department of Radiology, Gyeongsang National University Hospital, Gyeongsang National University School of Medicine, Jinju, Korea.

Corresponding author: Kyung Nyeo Jeon, MD. Department of Radiology, Gyeongsang National University Changwon Hospital, Gyeongsang National University School of Medicine, 11 Samjeongja-ro, Seongsan-gu, Changwon 51472, Korea. Tel. 82-55-214-3140 Fax. 82-55-214-3149, knjeon@gnu.ac.kr

Received 8 December 2015       Revised 30 January 2016       Accepted 23 March 2016

Copyright © 2016 The Korean Society of Radiology

(open-access):

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Purpose

To evaluate the incidence, severity, and risk factors of adverse drug reactions (ADR) to intravenous administration of nonionic iodinated contrast media in computed tomography (CT), and to determine the recurrence rate after premedication in patients with a previous history of ADR.

Materials and Methods

We prospectively recorded all ADR to intravenous CT contrast media in 32313 consecutive outpatients (54572 cases) who underwent contrast enhanced CT examinations. Clinical report forms and electronic medical records were reviewed to search for the incidence of ADR, treatment, and clinical outcome of patients. The risk factors of ADR to CT contrast media (age, sex, history of previous ADR, season) were evaluated using statistical analysis.

Results

Of the 54572 cases, a total of 191 (0.35%) had adverse reactions. Of the 191 cases, 157 (82%) were categorized as mild reactions, 29 (15%) were moderate, and 5 (3%) were severe. A total of 165 (86.4%) cases had acute adverse reactions (which occurred within 1 hour after administration), while 26 (13.6%) had delayed adverse reactions (occurred 1 hour after the administration). The rate of ADR was significantly higher in females [relative risk (RR) = 2.05, 95% confidence interval (CI) 1.53–2.75], patients under the age of 60 years (RR = 1.45, 95% CI 1.07–1.98), patients with a history of previous ADR (RR = 6.51, 95% CI 3.13–13.57), and in the spring season (RR = 1.44, 95% CI 1.07–1.95). The recurrence rate after premedication in patients with previous ADR to CT contrast media was 3.2% (8/247). No deaths occurred that were attributed to the contrast media.

Conclusion

The incidence of ADR to nonionic CT contrast media was 0.35%; most of which were mild reactions. Risk factors for ADR included female gender, an age of under 60 years, a history of previous ADR, and spring season.

Keywords: Allergy, Adverse Drug Reactions, CT, Contrast Agents, Republic of Korea

Figures and Tables

Fig. 1

Comparison of adverse drug reactions to CT contrast media by age. Bars represent mean values and error lines represent standard errors (Appendix 1).

jksr-75-41-g001
Fig. 2

Comparison of adverse drug reactions to CT contrast media by month of the year. Bars represent mean values and error lines represent standard errors (Appendix 2).

jksr-75-41-g002
Table 1

Patients' Demographics (n = 54572)

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Characteristics n (%)
Sex
 Male 32369 (59.3)
 Female 22203 (40.7)
Age, mean (range) 55.95 ± 15.2 (1–95) yrs
 < 60 years 31259 (57.3)
 ≥ 60 years 23313 (42.7)
Previous Hx of ADR
 Hx (+) → premedication 54325 (99.5)
 Hx (-) → no premedication 247 (0.5)
Seasonal distribution of CT examinations
 Spring 14629 (26.8)
 Summer 14035 (25.7)
 Autumn 12988 (23.8)
 Winter 12920 (23.7)

ADR = adverse drug reactions, Hx = history

Table 2

Type, Severity and Symptoms of ADR to CT Contrast Media

jksr-75-41-i002
Type of ADR & Sx* Pt. Group
Premedication (-) (n = 54325) Premedication (+) (n = 247) n (Total = 54572)
Acute (%) 159 6 165 (0.30)
 Mild 131 5 136
  Itching (101) (4) (105)
  Rash/ulticaria (90) (3) (93)
  Limited cutaneous edema (39) (2) (41)
  Cough (16) (1) (17)
  Febrile sense/flushing (8) (3) (11)
  Nausea/vomiting (5) (3) (8)
 Moderate 23 1 24
  Mild dyspnea (12) (1) (13)
  Hypotension (9) (9)
  Facial, laryngeal edema (4) (4)
 Severe 5 0 5
  Progressive dyspnea (1) (1)
  Mental change (2) (2)
  Severe hypotension/shock (3) (3)
Delayed (%) 24 2 26 (0.05)
 Mild 19 2 21
  Itching (15) (1) (16)
  Rash/ulticaria (17) (2) (19)
  Nausea/vomiting (1) (1)
 Moderate 5 0 5
  Diffuse rash/ulticaria (4) (4)
  Chest pain (1) (1)
 Severe 0 0 0
Total (%) 183 (0.34) 8 (3.2) 191 (0.35)

*Patients have one or more symptoms.

ADR = adverse drug reactions, Pt. = patient, Sx = symptom

Table 3

Risks of ADR to CT Contrast Media

jksr-75-41-i003
Predictor Reference Relative risk 95% CI
Female Male 2.05 1.53–2.75
< 60 years ≥ 60 years 1.45 1.07–1.98
Previous Hx of ADR (+) Previous Hx of ADR (-) 6.51 3.13–13.57
Spring Other seasons 1.44 1.07–1.95

ADR = adverse drug reactions, CI = confidence interval, Hx = history

Table 4

Treatment of ADR to CT Contrast Media

jksr-75-41-i004
Type & Severity of ADR Action n (%)
Acute (n = 165)
 Mild (n = 136) Observation 5 (2.6)
Hydration only 14 (7.3)
H1 ± PD 81 (42.4)
H1 + PD → ER 36 (18.9)
 Moderate (n = 24) H1 + PD ± O2 12 (6.3)
H1 + PD ± O2 ± E → ER 12 (6.3)
 Severe (n = 5) H1 + PD ± O2 ± E ± A → ER 5 (2.6)
 (intubation and ICU Tx) (1)
Delayed (n = 26)
 Mild (n = 21) H1 ± PD 21 (11)
 Moderate (n = 5) H1 + PD 4 (2.1)
H1 + PD + O2 1 (0.5)
Total 191 (100)

A = atropine, ADR = adverse drug reactions, E = epinephrine, ER = emergency room, H1 = histamine H1 receptor blocker, ICU Tx = treatment in the intensive care unit, O2 = oxygen inhalation, PD = corticosteroids

Acknowledgments

This Work (RPP-2015-022) was supported by the fund of Research Promotion Program, Gyeongsang National University, 2015.

Appendices

Appendix 1

Adverse Drug Reactions (ADR) to CT Contrast Media by Age

jksr-75-41-a001

Appendix 2

Adverse Drug Reactions (ADR) to CT Contrast Media by Month of the Year

jksr-75-41-a002

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