Clinical safety and diagnostic value of the gadolinium chelate gadoterate meglumine (Gd-DOTA).
OBJECTIVE
The purpose of this study was to assess the diagnostic value and safety of the contrast agent gadoterate meglumine (Gd-DOTA, DOTAREM, Guerbet, Roissy CdG Cedex, France) in the setting of a postmarketing surveillance study.


METHODS
Between January 2004 and October 2005, radiologists in 61 radiologic institutions were asked to document the routine use of Gd-DOTA in a questionnaire. In addition to assessing the image quality and diagnostic value of the contrast-enhanced magnetic resonance imaging scans, we statistically evaluated and analyzed demographic and safety data.


RESULTS
A total of 24,308 patients were intravenously injected with Gd-DOTA for various diagnostic examinations. The examination allowed for establishing a diagnosis in >99% of cases and image quality was rated as "excellent" or "good" in 97.5% of all cases. Adverse events were noted in only 0.4% of the examinations and were mostly rated as minor, such as feeling of warmth or taste alteration. There was one serious adverse event, albeit with complete recovery.


CONCLUSIONS
This postmarketing surveillance study suggests diagnostic efficacy and a favorable clinical safety profile of Gd-DOTA in clinical practice.
Herborn
Christoph U
CU
Medical Prevention Center Hamburg, Germany. herborn@mpch.de
Honold
Elmar
E
Wolf
Michael
M
Kemper
Jörn
J
Kinner
Sonja
S
Adam
Gerhard
G
Barkhausen
Jörg
J
D016907:Adverse Drug Reaction Reporting Systems; D016009:Chi-Square Distribution; D003287:Contrast Media / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006801:Humans; D007275:Injections, Intravenous; D008279:Magnetic Resonance Imaging; D008297:Male; D008536:Meglumine / Q000008:administration & dosage / Q000009:adverse effects; D009942:Organometallic Compounds / Q000008:administration & dosage / Q000009:adverse effects; D011358:Product Surveillance, Postmarketing; D012449:Safety; D011795:Surveys and Questionnaires
D003287:Contrast Media; D009942:Organometallic Compounds; D008536:Meglumine; C072417:gadoterate meglumine