Safety of Blood Pool Contrast Agent Administration in Children and Young Adults.
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.


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.


CONCLUSIONS
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.
1 Department of Medical Imaging, Ann & Robert H. Lurie Children's Hospital of Chicago, 225 E Chicago Ave, Chicago, IL 60611.|2 Department of Radiology, Northwestern University Feinberg School of Medicine, Chicago, IL.
Cynthia K
CK
Rigsby
1 Department of Medical Imaging, Ann & Robert H. Lurie Children's Hospital of Chicago, 225 E Chicago Ave, Chicago, IL 60611.|2 Department of Radiology, Northwestern University Feinberg School of Medicine, Chicago, IL.
Andrada R
AR
Popescu
1 Department of Medical Imaging, Ann & Robert H. Lurie Children's Hospital of Chicago, 225 E Chicago Ave, Chicago, IL 60611.
Paige
P
Nelson
3 Department of Pharmacy, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL.
R Jason
RJ
Orr
1 Department of Medical Imaging, Ann & Robert H. Lurie Children's Hospital of Chicago, 225 E Chicago Ave, Chicago, IL 60611.|4 Division of Epidemiology and Biostatistics, University of Illinois at Chicago School of Public Health, Chicago, IL.
Emma E
EE
Boylan
1 Department of Medical Imaging, Ann & Robert H. Lurie Children's Hospital of Chicago, 225 E Chicago Ave, Chicago, IL 60611.
Samantha
S
Schoeneman
5 Department of Pediatrics, Division of Pediatric Cardiology, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL.|6 Department of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, IL.
R Andrew
RA
deFreitas
D000293:Adolescent; D016907:Adverse Drug Reaction Reporting Systems; D002648:Child; D002675:Child, Preschool; D003287:Contrast Media / Q000008:administration & dosage / Q000009:adverse effects*; D005260:Female; D005682:Gadolinium / Q000008:administration & dosage / Q000009:adverse effects*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008279:Magnetic Resonance Imaging; D008297:Male; D009942:Organometallic Compounds / Q000008:administration & dosage / Q000009:adverse effects*; D012189:Retrospective Studies; D012449:Safety; D055815:Young Adult
D003287:Contrast Media; D009942:Organometallic Compounds; D005682:Gadolinium; C109932:gadofosveset trisodium
MRI; blood pool contrast agents; children; gadolinium-based contrast agents; safety