Acute Adverse Reactions to Gadopentetate Dimeglumine and Gadobenate Dimeglumine: Experience With 32,659 Injections

Abujudeh, Hani H.; Kosaraju, Vijaya; Kaewlai, Rathachai

doi:10.2214/ajr.09.3099

Cited by 84 publications

(69 citation statements)

References 14 publications

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“…Our results are completely in line with the recently published data extracted from the Euro-CMR study in which 30 acute adverse reactions (0.17%) occurred in a large cohort of 17,767 doses administered [31]. Similar findings were reported in larger studies analyzing the incidence of gadolinium-related contrast media reactions reporting event rates ranging between 0.04 and 2.2% [32][33][34].…”

Section: Safety Profilesupporting

confidence: 91%

Italian registry of cardiac magnetic resonance

Francone¹,

Cesare²,

Cademartiri³

et al. 2014

European Journal of Radiology

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Objectives Forty sites were involved in this multicenter and multivendor registry, which sought to evaluate indications, spectrum of protocols, impact on clinical decision making and safety profile of cardiac magnetic resonance (CMR). Materials and methods Data were prospectively collected on a 6-month period and included 3376 patients (47.2 ± 19 years; range 1-92 years). Recruited centers were asked to complete a preliminary general report followed by a single form/patient. Referral physicians were not required to exhibit any specific certificate of competency in CMR imaging. Results Exams were performed with 1.5 T scanners in 96% of cases followed by 3 T (3%) and 1 T (1%) magnets and contrast was administered in 84% of cases. The majority of cases were performed for the workup of inflammatory heart disease/cardiomyopathies representing overall 55.7% of exams followed by the assessment of myocardial viability and acute infarction (respectively 6.9% and 5.9% of patients). In 49% of cases the final diagnosis provided was considered relevant and with impact on patient's clinical/therapeutic management. Safety evaluation revealed 30 (0.88%) clinical events, most of which due to patient's preexisting conditions. Radiological reporting was recorded in 73% of exams. Conclusions CMR is performed in a large number of centers in Italy with relevant impact on clinical decision making and high safety profile. © 2013 Elsevier Ireland Ltd

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Section: Safety Profilesupporting

confidence: 91%

Italian registry of cardiac magnetic resonance

Francone¹,

Cesare²,

Cademartiri³

et al. 2014

European Journal of Radiology

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“…However, the use of any contrast medium carries a potential risk and, in the case of gadolinium-based media, nephrotoxicity and allergic reactions can result [31,32], although they are infrequent and usually mild.…”

Section: Discussionmentioning

confidence: 99%

Is there a role for free breathing non-contrast steady-state free precession renal MRA imaging for assessing live donors? A preliminary study

Laurence

Ariff²,

Quest³

et al. 2012

The British Journal of Radiology

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Objective: Accurate pre-operative evaluation of renal vascular anatomy is essential for successful renal harvest in live donor transplantation. Non-contrast renal MR angiographic (MRA) techniques are potentially well suited to the screening of donors; however, their restricted imaging field of view (FOV) has previously been an important limitation. We sought to assess whether the addition of a large FOV balanced fast field echo (BFFE) steady-state free precession (SSFP) sequence to non-contrast SSFP MRA could overcome this problem. Comparison with contrast-enhanced MRA (CE MRA) and findings at surgery were performed. Methods: 22 potential renal donors each underwent SSFP and CE MRA. 11 out of 22 potential donors subsequently underwent a donor nephrectomy. Results: All images were diagnostic. Both SSFP MRA and CE MRA identified an equal number of arteries. Surgery confirmed two accessory renal arteries, both demonstrated with both imaging techniques. A third accessory vessel was identified with both techniques on a kidney contralateral to the donated organ. 6 out of 11 procured kidneys demonstrated early branch arteries at surgery, 5 out of 6 of which had been depicted on both SSFP and CE MRA. The median grading of image quality for main renal arteries was slightly better for CE MRA (p50.048), but for accessory vessels it was better for SSFP MRA. Conclusion: This pilot study indicates that by combining free-breathing SSFP MRA with large-FOV bFFE images, an accurate depiction of renal vascular anatomy without the need for intravenous contrast administration can be obtained, as compared with surgical findings and CE MRA. Living donor transplantation is becoming an increasingly important treatment option for end-stage renal failure (ESRF). The high prevalence of anatomical variants in renal vascular anatomy underscores the importance of accurate pre-operative evaluation of the vascular anatomy [1, 2], particularly in patients undergoing a laparoscopic approach, as the surgical field of view (FOV) is limited. Multiple renal arteries in the donor kidney result in a substantial increase in the risk of complications. Moreover, the presence of accessory arteries and early branches of the renal arteries, as well as variants in venous anatomy, can all affect the surgical decision for suitability for donor harvest [3,4].Although there has been some debate about the optimal imaging strategy for potential renal donors [5][6][7], with concerns raised over the ability of contrast-enhanced MR angiography (CE MRA) to detect all renal arteries [8], there is evidence to support the sole use of CE MRA for this purpose [9]. Non-contrast MRA techniques have been used for several years, but have been generally overshadowed by the more popular contrast-enhanced techniques [10]. CT angiography is a proven tool in this domain. It also has the ability to detect parenchymal abnormalities and calculi; however, its use of ionising radiation is a disadvantage that should be considered when evaluating a donor population [11,12].Balanced steady-...

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“…On the basis of published data, rates of adverse reactions following GBCA administration range between 0.03% and 2.4%. 56 Adverse drug reactions fall into 2 major categories. The first includes reactions that can occur in any patient, such as drug overdose and drug interactions; the second includes reactions that are restricted to susceptible patients, such as drug toxicity/augmented effects (ie, drug idiosyncrasy or reduced tolerance) and hypersensitivity reactions that are either allergic or pseudoallergic in nature.…”

Section: Adverse Reactionsmentioning

confidence: 99%

“…56,76,78 After experience is accumulated by using a given product, previously noteworthy reactions are perceived as being predictable and less noteworthy and, therefore, may be reported less frequently. 56,76,78 Thus, the Weber effect is characterized by a transient increase in adverse event reporting that tends to peak in the second year following introduction of a new agent, with a subsequent return to the original baseline reaction rate observed before the introduction of the new agent. 76 Such an effect was recently reported with GBCAs by Davenport et al, 79 who described the impact of an abrupt switch from Magnevist to MultiHance on the incidence of immediate allergic-type adverse events.…”

Section: 77mentioning

confidence: 99%

“…This may result in unpredictable, idiosyncratic reactions of varying severity. 77 Both of these effects have been observed with contrast agents 56,77,79 ; however, true differences between agents in terms of severe acute reaction rates have not been demonstrated in wellcontrolled, statistically powered, prospective, randomized, blinded studies. 78 The main reason for the lack of such studies is their complexity, duration, and cost due to the low incidence of adverse events.…”

Section: 77mentioning

confidence: 99%

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Gadolinium Contrast Agents for CNS Imaging: Current Concepts and Clinical Evidence

Kanal

Maravilla

Rowley

2014

AJNR Am J Neuroradiol

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SUMMARY:The aim of this article was to review the properties of the various gadolinium-based contrast agents used for CNS imaging along with the clinical evidence and published data that highlight the impact these different properties can have on diagnostic performance. In addition, approaches to optimizing image acquisition that take into account the different properties of specific gadoliniumbased contrast agents and an extensive review of the safety profiles of the various agents are presented. ABBREVIATIONS:CE ϭ contrast-enhanced; CNR ϭ contrast-to-noise ratio; GBCA ϭ gadolinium-based contrast agent; Gd ϭ gadolinium; NSF ϭ nephrogenic systemic fibrosis; rCBV ϭ relative cerebral blood volume; rCBF ϭ relative cerebral blood flow O f the 9 gadolinium-based contrast agents (GBCAs) approved by the United States FDA for contrast-enhanced (CE) MR imaging, 7 (gadoterate meglumine, Dotarem, Guerbet, Aulnay-sous-Bois, France; gadobutrol, Gadavist, Bayer HealthCare Pharmaceuticals, Wayne, New Jersey; gadopentetate dimeglumine, Magnevist, Bayer HealthCare; gadobenate dimeglumine, MultiHance, Bracco Diagnostics, Princeton, New Jersey; gadodiamide, Omniscan, GE Healthcare, Milwaukee, Wisconsin; gadoversetamide, OptiMARK, Covidien, Dublin, Ireland; gadoteridol, ProHance, Bracco Diagnostics) are approved specifically for CE-MR imaging of the CNS. Although numerous studies published in high-ranking peerreviewed journals have confirmed the safety and efficacy of the 7 GBCAs approved for CNS imaging, differences among these agents and the impact these differences may have on diagnostic sensitivity and clinical decision-making remain underappreciated and sometimes misunderstood.The aim of this article was to review the properties of the various GBCAs used for CNS imaging together with the clinical evidence and published data that highlight the impact these different properties can have on diagnostic performance. In addition, approaches to optimizing image acquisition that take into account the different properties of specific GBCAs and an extensive review of the safety profiles of the various agents will be presented.For the purposes of the present review, brand names rather than chemical names have been used throughout to refer to the various GBCAs. Although chemical names would ordinarily be used in a review article such as this, it was thought that because the actual practitioners of MR imaging are typically more familiar with brand names than with chemical names, the use of brand names would help avoid the possibility of obfuscation and thereby enhance clarity in this field. Moreover, because generic formulations of these agents are not available in the United States, these brand names are clinically relevant designations. We have therefore elected to specifically use the same brand names for the various agents with which the reader will be most familiar. GBCAS: WHAT THEY ARE AND WHAT THEY DOAs a heavy metal in the lanthanide series, elemental free gadolinium (Gd) is toxic to humans. GBCAs are formed by chelation of gadolin...

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Acute Adverse Reactions to Gadopentetate Dimeglumine and Gadobenate Dimeglumine: Experience With 32,659 Injections

Cited by 84 publications

References 14 publications

Italian registry of cardiac magnetic resonance

Italian registry of cardiac magnetic resonance

Is there a role for free breathing non-contrast steady-state free precession renal MRA imaging for assessing live donors? A preliminary study

Gadolinium Contrast Agents for CNS Imaging: Current Concepts and Clinical Evidence

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