Safety of gadoterate meglumine in children younger than 2 years of age

Farmakis, Shannon G.; Hardy, Anna K.; Mahmoud, Shamsheldeen Y.; Wilson-Flewelling, S.; Tao, Ting Y.

doi:10.1007/s00247-020-04626-z

Cited by 4 publications

(2 citation statements)

References 31 publications

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“…In terms of safety, our findings confirm the low incidence of acute/subacute adverse events reported by Cho et al [ 11 ] in adult and pediatric subjects undergoing routine contrast-enhanced MRI with gadoteridol. Moreover, they bear excellent comparison with findings for other macrocyclic GBCAs in children under 2 years of age [ 17 , 25 – 28 ].…”

Section: Discussionmentioning

confidence: 58%

Safety and diagnostic efficacy of gadoteridol for magnetic resonance imaging of the brain and spine in children 2 years of age and younger

et al. 2021

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Background Neonates and young children require efficacious magnetic resonance imaging (MRI) examinations but are potentially more susceptible to the short- and long-term adverse effects of gadolinium-based contrast agents due to the immaturity of their body functions. Objective To evaluate the acute safety and diagnostic efficacy of gadoteridol (ProHance) for contrast-enhanced MRI of the central nervous system (CNS) in children ≤2 years of age. Materials and methods One hundred twenty-five children ≤2 years old (including 57 children <6 months old) who underwent contrast-enhanced MRI of the CNS with gadoteridol at 0.1 mmol/kg body weight were retrospectively enrolled at five imaging centers. Safety data were assessed for acute/subacute adverse events in the 48 h following gadoteridol administration and, when available, vital signs, electrocardiogram (ECG) and clinical laboratory values obtained from blood samples taken from 48 h before until 48 h following the MRI exam. The efficacy of gadoteridol-enhanced MRI compared to unenhanced MRI for disease diagnosis was evaluated prospectively by three blinded, unaffiliated readers. Results Thirteen changes of laboratory values (11 mild, 1 moderate, 1 unspecified) were reported as adverse events in 7 (5.6%) patients. A relationship to gadoteridol was deemed possible though doubtful for two of these adverse events in two patients (1.6%). There were no clinical adverse events, no serious adverse events and no clinically meaningful changes in vital signs or ECG recordings. Accurate differentiation of tumor from non-neoplastic disease, and exact matching of specific MRI-determined diagnoses with on-site final diagnoses, was achieved in significantly more patients by each reader following the evaluation of combined pre- and post-contrast images compared to pre-contrast images alone (84.6–88.0% vs. 70.9–76.9%; P≤0.006 and 67.5–79.5% vs. 47.0–66.7%; P≤0.011, respectively). Conclusion Gadoteridol at 0.1 mmol/kg body weight is safe, well tolerated and effective for contrast-enhanced MRI of the CNS in children ≤2 years of age.

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Section: Discussionmentioning

confidence: 58%

Safety and diagnostic efficacy of gadoteridol for magnetic resonance imaging of the brain and spine in children 2 years of age and younger

et al. 2021

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“…Only one patient developed a rash of moderate intensity. In the research by Farmakis et al adverse reactions included vomiting (8.7%), transient flushing or warmth (5.3%), nausea (4.7%), dizziness (0.7%) and altered taste (0.7%) (19). Two allergy-like reactions were recorded in 2 patients (sneezing and non-specific sounds when breathing).…”

Section: Resultsmentioning

confidence: 98%

Kontrastna sredstva na bazi gadolinija u pedijatrijskoj populaciji

Gabela,

Budimir Mršić

2023

Hrvat. čas. zdr. znan.

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With the advancement of technology and development of magnetic resonance imaging, a major turning point in the field of radiology occurred in the twentieth century. Visualization of all parts of the human body was greatly facilitated while maintaining excellent spatial resolution without the use of ionizing radiation. In the pediatric population, this method is especially useful in the evaluation of the brain, thorax, abdomen, pelvis, and extremities. This is one of the first methods of choice for younger patients due to the non-use of ionizing radiation. Magnetic resonance contrast agents are used to increase the contrast of the obtained image and better resolution. The most used contrast agents include Gadolinium-Based Contrast Agents, whose first application took place in 1983. According to their molecular structure, they are divided into linear and macrocyclic, and in addition, they can be divided into ionic and nonionic. Macrocyclic compounds are generally considered safer due to the lower rate of dissociation of the free gadolinium ion, which is toxic in this form. Gadolinium-Based Contrast Agents have long been believed to be completely safe, but their association with nephrogenic systemic fibrosis was observed in the 2000s, after which the focus was on the use of macrocyclic compounds in pediatric patients for proven safety. In addition to the mentioned side effects, the development of acute allergic reactions is also possible, and more recently, findings on the deposition of gadolinium in tissues have been discovered. Despite the very low rate of all these side effects in pediatric patients, their long-term safety and use in the neonatal age has not yet been established. Precisely because of this, they should be applied with caution, with an emphasis on the application of the lowest possible doses, the use of macrocyclic chelates and a good risk assessment. This review paper collects and analyses so far published research on Gadolinium-Based Contrast Agents in the pediatric population.

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