[Multicenter analysis of tolerance and clinical safety of the extracellular MR contrast agent gadobenate dimeglumine (MultiHance)].
OBJECTIVE
Retrospective analysis of the occurrence of adverse events and the diagnostic efficacy of a paramagnetic contrast agent with weak intermittent protein binding and high relaxivity.


METHODS
Postmarketing surveillance studies for gadobenate dimeglumine (MultiHance, BRACCO Altana Pharma, Constance) were conducted in Germany between 1998 and 2006 and then retrospectively analyzed. Demographic data, relevant comorbidities, and allergies were recorded. The safety and tolerability of MultiHance were logged on a standardized data sheet.


RESULTS
A total of 38,568 patients were included in the study. 829 patients (2.1%) had a known intolerance against contrast media. The examined regions included the central nervous system, the liver, and the vascular bed. The injection rate with automated injectors (n = 10456) varied between 1.0 und 3.0 ml/sec in 86.5% of patients. Adverse events totaled 1.2%. 11 patients (0.03%) experienced serious adverse events. The most frequent findings were nausea, vomiting and a feeling of warmth.


CONCLUSIONS
MultiHance is a safe and very well tolerated contrast agent for magnetic resonance imaging (MRI) with a profile and frequency of adverse events similar to other extracellular MR contrast materials.
Herborn
C U
CU
Universitätsklinikum Hamburg-Eppendorf, Medizinisches PräventionsCentrum Hamburg. herborn@mpch.de
Jäger-Booth
I
I
Lodemann
K P
KP
Spinazzi
A
A
Goyen
M
M
D000293:Adolescent; D000328:Adult; D000368:Aged; D001921:Brain / Q000473:pathology; D002648:Child; D002675:Child, Preschool; D003287:Contrast Media / Q000009:adverse effects*; D004305:Dose-Response Relationship, Drug; D005260:Female; D005858:Germany; D006801:Humans; D007089:Image Enhancement / Q000379:methods*; D007091:Image Processing, Computer-Assisted / Q000379:methods*; D007223:Infant; D007262:Infusions, Intravenous; D008279:Magnetic Resonance Imaging / Q000379:methods*; D008297:Male; D008536:Meglumine / Q000009:adverse effects / Q000031:analogs & derivatives*; D008875:Middle Aged; D054989:Nephrogenic Fibrosing Dermopathy / Q000139:chemically induced; D009942:Organometallic Compounds / Q000009:adverse effects*; D012307:Risk Factors; D013116:Spinal Cord / Q000473:pathology; D055815:Young Adult
D003287:Contrast Media; D009942:Organometallic Compounds; C064572:gadobenic acid; D008536:Meglumine