Clinical safety and diagnostic value of the gadolinium chelate gadoterate meglumine (Gd-DOTA).

Abstract:

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. MATERIALS AND 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. CONCLUSION:This postmarketing surveillance study suggests diagnostic efficacy and a favorable clinical safety profile of Gd-DOTA in clinical practice.

journal_name

Invest Radiol

journal_title

Investigative radiology

authors

Herborn CU,Honold E,Wolf M,Kemper J,Kinner S,Adam G,Barkhausen J

doi

10.1097/01.rli.0000248893.01067.e5

subject

Has Abstract

pub_date

2007-01-01 00:00:00

pages

58-62

issue

1

eissn

0020-9996

issn

1536-0210

pii

00004424-200701000-00008

journal_volume

42

pub_type

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