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. 2007 Jan;42(1):58-62.
doi: 10.1097/01.rli.0000248893.01067.e5.

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

Christoph U Herborn  1 , Elmar Honold, Michael Wolf, Jörn Kemper, Sonja Kinner, Gerhard Adam, Jörg Barkhausen
Affiliations

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

Christoph U Herborn et al. Invest Radiol. 2007 Jan.

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.

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