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Safety of Blood Pool Contrast Agent Administration in Children and Young Adults
Cynthia K Rigsby1,2, Andrada R Popescu1,2, Paige Nelson1
11 Department of Medical Imaging, Ann & Robert H. Lurie Children's Hospital of Chicago, 225 E Chicago Ave, Chicago, IL 60611.
Insights
Gadofosveset trisodium contrast agent adverse reactions are mostly mild in pediatric patients. However, severe allergiclike reactions can occur, necessitating careful monitoring and treatment protocols.
Area of Science:
- Radiology
- Pediatric Imaging
- Pharmacovigilance
Background:
- Blood pool contrast agents are crucial for MRI diagnostics in pediatric populations.
- Understanding the safety profile of gadofosveset trisodium in children and young adults is essential.
Purpose of the Study:
- To determine the adverse reaction rate associated with gadofosveset trisodium in pediatric patients.
- To compare adverse event rates between anesthetized and non-anesthetized pediatric patients.
Main Methods:
- Retrospective review of MRI and pharmacy databases for patients receiving gadofosveset trisodium (2011-2014).
- Classification of patients based on anesthesia status during MRI.
- Analysis of electronic medical records for adverse reactions within 24 hours of administration.
- Calculation of risk ratios for adverse events between patient groups.
Main Results:
- A total of 711 doses were administered to 626 pediatric patients, with an overall adverse reaction rate of 19.3%.
- Anesthetized patients experienced a significantly higher adverse reaction rate (31.3%) compared to non-anesthetized patients (6.4%).
- Severe allergiclike reactions were rare (0.28%) but occurred, with prompt treatment leading to no adverse outcomes.
Conclusions:
- The majority of gadofosveset trisodium reactions in pediatric patients are mild.
- Severe allergiclike reactions, though infrequent, necessitate established treatment policies.
- These findings support informed decision-making for centers using gadofosveset trisodium in pediatric imaging.
Objective:
The objective of our study was to determine the adverse reaction rate associated with the administration of blood pool contrast material in children and young adults.
Materials And Methods:
A review of the MRI and pharmacy databases identified all patients who received gadofosveset trisodium from October 1, 2011, to June 30, 2014. Patients were classified as having been anesthetized or not anesthetized for the MRI examinations. A review of the electronic medical records identified adverse reactions recorded within 24 hours of contrast administration. The adverse reactions were graded as mild, moderate, or severe. Risk ratios were calculated between the adverse reaction rate experienced by anesthetized patients and that experience by nonanesthetized patients.
Results:
During the study period, 626 patients (mean age, 11.7 years) received 711 doses of gadofosveset trisodium; 137 adverse reactions were recorded, which yields a 19.3% (137/711) adverse reaction rate. There were 115 adverse reactions experienced by 367 anesthetized patients (31.3%): 93.0% (107/115) were mild and 7.0% (8/115) were moderate. The remaining 22 adverse reactions were experienced by 344 (6.4%) nonanesthetized patients, and 90.9% (20/22) were mild. Three nonanesthetized patients had allergiclike reactions; of these allergiclike reactions, one was mild and two were severe for a severe allergiclike reaction rate of 0.28% (2/711). Severe allergiclike reactions were treated without any adverse outcomes. Anesthetized patients were 5.7 times more likely to experience an adverse event than nonanesthetized patients; most reactions in anesthetized patients were seen after the administration of anesthesia alone.
Conclusion:
Most reactions after gadofosveset trisodium administration in children and young adults are mild; however, severe allergiclike reactions occur, so policies must be in place to treat patients with adverse reactions when using this contrast agent. These data may be useful to centers considering administering gadofosveset trisodium to pediatric patients.
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