Adverse reactions to ionic and nonionic contrast media. A report from the Japanese Committee on the Safety of Contrast Media.

Katayama, Hitoshi; Yamaguchi, Koichi; Kozuka, Takenori; Takashima, T; Seez, P; Matsuura, Kazuki

doi:10.1148/radiology.175.3.2343107

Cited by 1,311 publications

(726 citation statements)

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“…In these studies adverse events after i. v. CM administration ranged between 0.2 % and 3.1 %. Similar ADR rates were also observed in larger trials [21,22]. The number of allergy-like adverse drug reactions is comparable to other published NIS with non-ionic contrast media [10,23].…”

supporting

confidence: 87%

Post-Marketing Surveillance of the Safety Profile of Iodixanol in the Outpatient CT Setting: A Prospective, Multicenter, Observational Study of Patient Risk Factors, Adverse Reactions and Preventive Measures in 9953 Patients

Müller

2014

Fortschr Röntgenstr

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Purpose: Non-interventional study in outpatient, contrast-enhanced CT 1. to determine the extent of preventive measures for risk reduction of adverse drug reactions after contrast-enhanced CT examinations. 2. to prospectively determine the incidence and severity of adverse drug reactions occurring after administration of the iso-osmolar contrast medium iodixanol 3. to determine a possible influence of preventive measures on the incidence/severity of adverse drug reactions. Materials and Methods: Evaluable documentation was provided for 9953 patients from 66 radiology centers across Germany. Patient characteristics, aspects of iodixanol administration, and adverse events with an at least "possible" relationship were documented on a standardized case report form (CRF) and were evaluated up to seven days after contrast medium administration. Results: About 55.5 % of patients showed one or more risk factors (e. g. impaired renal function 4.4 %, diabetes mellitus 8.5 %, hypertension 20.6 %). One third of the sites did not implement any preventive measures. Patients with a known risk for an allergy-like reaction were more likely to receive pharmacologic preventive treatment (0.5 -50.5 %). Oral hydration was the main preventive measure in patients with renal risk factors (< 8 %) followed by intravenous hydration (1 %). Adverse drug reactions, mainly hypersensitivity reactions, occurred in 77 patients (0.74 %), but were classified as serious in only 3 patients (0.03 %). No statistically significant correlation between risk factors, preventive measures, and adverse reactions could be found. Conclusion: The use of preventive measures for CT examinations in this outpatient setting was generally low with risk patients being pre-medicated This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited.

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confidence: 87%

Post-Marketing Surveillance of the Safety Profile of Iodixanol in the Outpatient CT Setting: A Prospective, Multicenter, Observational Study of Patient Risk Factors, Adverse Reactions and Preventive Measures in 9953 Patients

Müller

2014

Fortschr Röntgenstr

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“…Based on this, it is estimated that the administration of ICM is performed at least 100 million times each year worldwide. Although low-osmolality ICM agents have an excellent safety/risk profile, adverse drug reactions (ADRs) in general or hypersensitivity reactions (HSRs) in particular occur in approximately 3 -30 % and 1 -3 %, respectively [3,4]. HSRs are per definitionem so-called type B reactions [5] and therefore are not predictable.…”

Section: Introductionmentioning

confidence: 99%

Iodinated Contrast Media and the Alleged “Iodine Allergy”: An Inexact Diagnosis Leading to Inferior Radiologic Management and Adverse Drug Reactions

Böhm

Nairz

Morelli

et al. 2017

Fortschr Röntgenstr

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ZUSAMMENFASSUNGZiel Ziel dieser Studie war die Überprüfung der Hypothese, dass die ungenaue Diagnose "Jodallergie" für Patienten unter radiologischen Routinebedingungen möglicherweise gefährlich ist. ABSTR ACTPurpose To test the hypothesis that the incomplete diagnosis "iodine allergy" is a possibly dangerous concept for patients under routine radiologic conditions. Materials and Methods 300 patients with a history of an "iodine allergy" were retrospectively screened and compared with two age-, sex-, and procedure-matched groups of patients either diagnosed with a nonspecific "iodine contrast medium (ICM) allergy" or an allergy to a specific ICM agent. For all groups, the clinical symptoms of the This document was downloaded for personal use only. Unauthorized distribution is strictly prohibited. most recent past adverse drug reaction (ADR), prophylactic actions taken for subsequent imaging, and ultimate outcome were recorded and analyzed.Results The diagnosis "iodine allergy" was not otherwise specified in 84.3 % patients. For this group, in most cases, the symptoms of the previous ADRs were not documented. In contrast, the type of ADR was undocumented in only a minority of patients in the comparison groups. In the group of patients with an "iodine allergy" the percentage of unenhanced CT scans was greater than within the other two groups (36.7 % vs. 28.7 %/18.6 %). ADRs following prophylactic measures were only observed in the "iodine allergy" group (OR of 9.24 95 % CI 1. 16 -73.45; p < 0.04).Conclusion This data confirms the hypothesis that the diagnosis "iodine allergy" is potentially dangerous and results in uncertainty in clinical management and sometimes even ineffective prophylactic measures.Key points ▪ The term "iodine allergy" is imprecise, because it designates allergies against different substance classes, such as disinfectants with complexed iodine and contrast media containing covalently bound iodine. ▪ There is a clear correlation between the exactness of the diagnosis -from the alleged "iodine allergy" to "contrast media allergy" to naming the exact culprit CM -and the quality of documentation of the symptoms. ▪ Management of patients diagnosed with "iodine allergy" was associated with uncertainty leading to unenhanced scans and sometimes unnecessary prophylactic actions. ▪ The term "iodine allergy" should be omitted, because it is potentially dangerous and can decrease the quality of radiology exams.

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“…However, many undesirable adverse reac tions to RCM including allergic, renal, vascular and cardiac effects have been reported (1). Even the nonionic RCM with lower osmolarity induce these reactions, although the incidence has been reported to be reduced as compared with ionic RCM (2).…”

Section: Iodinated Radiographicmentioning

confidence: 99%

“…With the use of these novel preparations, the incidence of overall ad verse reactions was reduced from 12.66% of patients who received higher osmolar RCM to 3.31 %, and the inci dence of severe anaphylactoid reactions (sudden drop in blood pressure, cardiac arrest, loss of consciousness, or dyspnea requiring treatment) was reduced from 0.22% to 0.04% (2).…”

Section: Iodinated Radiographicmentioning

confidence: 99%

Enhancement by Morphine of Radiographic Contrast Media-Induced Histamine Release in Rat Peritoneal Mast Cells.

et al. 1997

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ABSTRACT-The intravascular application of radiographic contrast media causes hypersensitivity reac tions, in which histamine release may play a major role. We examined the interaction between contrast medium and morphine. Among the four nonionic contrast media examined, iopamidol showed the most marked histamine release from rat peritoneal mast cells in vitro. Although iopamidol and morphine them selves did not induce histamine release at concentrations up to 65 mgI/ml and 3 mM, respectively, their combination resulted in a significant histamine release. These findings suggest that patients with exposure to medicines that induce histamine release may have a higher incidence and severity of hypersensitivity reac tions to radiographic contrast media.

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Adverse reactions to ionic and nonionic contrast media. A report from the Japanese Committee on the Safety of Contrast Media.

Cited by 1,311 publications

References 0 publications

Post-Marketing Surveillance of the Safety Profile of Iodixanol in the Outpatient CT Setting: A Prospective, Multicenter, Observational Study of Patient Risk Factors, Adverse Reactions and Preventive Measures in 9953 Patients

Post-Marketing Surveillance of the Safety Profile of Iodixanol in the Outpatient CT Setting: A Prospective, Multicenter, Observational Study of Patient Risk Factors, Adverse Reactions and Preventive Measures in 9953 Patients

Iodinated Contrast Media and the Alleged “Iodine Allergy”: An Inexact Diagnosis Leading to Inferior Radiologic Management and Adverse Drug Reactions

Enhancement by Morphine of Radiographic Contrast Media-Induced Histamine Release in Rat Peritoneal Mast Cells.

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