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      Fatal anaphylactic reaction to intravenous gadobutrol, a gadolinium-based MRI contrast agent

      case-report
      Author(s): , MD a , * , , MD b , , MD b , , MD b , , Prof., MD, Executive MBA HSG b
      Publication date (Electronic):
      Journal: Radiology Case Reports
      Publisher: Elsevier
      Keywords: Gadobutrol, Gadolinium, Anaphylactic reaction, MRI

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          Abstract

          We present the rare case of a fatal anaphylactic reaction to gadobutrol, a magnetic resonance imaging contrast agent, in a 42-year-old man. The patient underwent elective magnetic resonance imaging for diagnostic clarification of a suspicious finding in the abdomen. The patient had undergone contrast-enhanced computed tomography previously without the occurrence of any adverse effects. Adverse drug reactions in gadobutrol have a very low prevalence of 0.32%-3.5%, with serious adverse drug reactions in <0.1%. There are only a few cases of fatal anaphylactoid reactions to gadolinium-based contrast agents in general. However, if an anaphylactoid reaction occurs, it can present itself with a fulminant course within minutes.

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          Safe Use of Contrast Media: What the Radiologist Needs to Know.

          Katrina R Beckett, Andrew Moriarity, Jessica Langer (2015)
          Iodinated and gadolinium-based contrast media are used on a daily basis in most radiology practices. These agents often are essential to providing accurate diagnoses, and are nearly always safe and effective when administered correctly. However, reactions to contrast media do occur and can be life threatening. Therefore, it is critical for faculty and staff to know how reactions to contrast agents manifest and how to treat them promptly. The decline in renal function seen occasionally after intravenous administration of iodinated contrast agents is poorly understood and likely multifactorial, and its association with the contrast medium may be overemphasized. However, it is important that radiologists be aware of current understanding and strategies to decrease the incidence of renal dysfunction. Nephrogenic systemic fibrosis, a skin disease, is an adverse reaction related to use of some gadolinium-based contrast agents in patients with chronic renal failure. The types of gadolinium most often associated with this condition and the indications for withholding gadolinium are important and are discussed in this article. The use of enteric contrast agents and contrast agents during pregnancy and nursing are reviewed briefly. Current knowledge for safe use of contrast media and key concepts that all radiologists should know are summarized in this review.
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            Prevalence of acute adverse reactions to gadobutrol--a highly concentrated macrocyclic gadolinium chelate: review of 14,299 patients from observational trials.

            Michael Forsting, Petra Palkowitsch (2010)
            To determine the safety and tolerability of gadobutrol in a large number of non-selected patients from routine clinical radiology practices. Six prospectively planned, observational surveillance studies were conducted at more than 300 institutions in Europe and Canada from 2000 to 2007. Demographic and medical status data, details of the diagnostic procedure, contrast agent administration and adverse drug reaction (ADR) data were collected using a standardized questionnaire. A total of 14,299 patients were enrolled. The mean age of the patients was 53.7 years; 1.3% of the patients were <18 years old and 40.8% were 60 years or older. The body regions most frequently examined were head/neck/brain (54.3%), followed by spine (7.2%), pelvis/joints/limbs (6.7%) and multiple body regions (6.4%). Gadobutrol-enhanced magnetic resonance angiography (MRA) was performed in 14.7% of patients. Overall, the mean volume of gadobutrol administered for contrast-enhanced magnetic resonance imaging was 12 mL (0.16 mmol gadolinium [Gd]/kg body weight [BW]; mean BW: 75.5 kg), whereas for contrast-enhanced MRA the mean volume was 15.7 mL (0.21 mmol Gd/kg BW). Seventy-eight of the 14,299 patients (0.55%) reported at least one ADR. Two (0.01%) serious ADRs were reported. The most frequently reported ADR was nausea, which occurred in 36 patients (0.25%). Gadobutrol 1.0M is very well tolerated and has a good safety profile. The occurrence of ADRs observed following the intravenous injection of gadobutrol is comparable with the published data of other Gd-based contrast agents. Copyright (c) 2009 Elsevier Ireland Ltd. All rights reserved.
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              Safety of Gadobutrol

              Jan Endrikat, Kai Vogtlaender, Susan Dohanish … (2016)
              Objective The aim of this study was to provide a systematic safety analysis of gadobutrol after more than 29 million applications in clinical routine. Materials and Methods Forty-two clinical development phase II to IV studies on gadobutrol or comparator and the postmarketing safety surveillance database for gadobutrol (1998–2015) were analyzed. Adverse events (AEs) and drug-related AEs were evaluated in the clinical development database and spontaneous adverse drug reactions (ADRs) in the postmarketing database. Subgroup analyses were run on patients with special medical history and on patients of different age groups. Results In the clinical development studies, 6809 and 2184 patients received gadobutrol or comparators, respectively. The incidence of drug-related AEs was 3.5% for both groups. With the exception of nausea (0.7% related cases in both groups), all other drug-related AEs were 0.3% or less in both groups. Hypersensitivity reactions were sporadic (<0.1%). Patients with history of allergies to contrast agents experienced slightly more drug-related AEs. No differences were seen between age groups. The overall reporting rate of ADRs from postmarketing surveillance was 0.05%. The most frequent ADRs were anaphylactoid/hypersensitivity reactions, nausea, vomiting, and dyspnea. For 3 single-agent reports of nephrogenic systemic fibrosis, using a conservative approach, association with gadobutrol could not be excluded. Conclusions Gadobutrol is well tolerated and has a favorable safety profile for patients of all age groups.
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                Author and article information

                Contributors
                Sabine Franckenberg
                Journal
                Journal ID (nlm-ta): Radiol Case Rep
                Journal ID (iso-abbrev): Radiol Case Rep
                Title: Radiology Case Reports
                Publisher: Elsevier
                ISSN (Electronic): 1930-0433
                Publication date PMC-release: 01 November 2017
                Publication date Collection: February 2018
                Publication date (Electronic): 01 November 2017
                Volume: 13
                Issue: 1
                Pages: 299-301
                Affiliations
                [a ]Institute of Diagnostic and Interventional Radiology, University Hospital of Zurich, Raemistrasse 100, 8091 Zurich, Switzerland
                [b ]Institute of Forensic Medicine, University of Zurich, 8057 Zurich, Switzerland
                Author notes
                [* ]Corresponding author. sabine.franckenberg@ 123456usz.ch
                Article
                Publisher ID: S1930-0433(17)30366-7
                DOI: 10.1016/j.radcr.2017.09.012
                PMC ID: 5851274
                PubMed ID: 29552267
                SO-VID: 11cec97e-af38-4572-8182-29e7239d3e66
                Copyright © © 2017 The Authors
                License:

                This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

                History
                Date received : 18 August 2017
                Date revision received : 6 September 2017
                Date accepted : 8 September 2017
                Categories
                Subject: Quality and Safety

                Keywords: gadobutrol,gadolinium,anaphylactic reaction,mri
                Data availability:
                Keywords: gadobutrol, gadolinium, anaphylactic reaction, mri

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