A review of preclinical safety data for magnevist (gadopentetate dimeglumine) in the context of nephrogenic systemic fibrosis

Investigative Radiology
Thomas Steger-HartmannJacob Walter

Abstract

Magnevist (gadopentetate dimeglumine, Bayer Healthcare, Bayer) is a gadolinium-based contrast agent (GBCA) for magnetic resonance imaging approved for clinical use in various indications since 1988. A possible association between the administration of GBCAs to patients with severe kidney impairment, and a condition first identified in 2000 and later described as "nephrogenic systemic fibrosis" (NSF), was published in early 2006. In the light of this reported association and the published histologic findings of certain NSF patients, Bayer, with support of external experts, reassessed the preclinical safety data from in vivo studies in healthy rats and dogs that were conducted with Magnevist during the drug development process in the mid-80s. These studies, which were performed according to standard regulatory requirements as defined in pertinent guidelines and which were conducted before the reported association between GBCAs and NSF, were not specifically designed to detect NSF-like lesions. Instead, the intention of this reassessment was to analyze whether the acquired knowledge on NSF would lead to a revised interpretation of the original preclinical data. Studies on repeat-dose toxicity of Magnevist performed in the mid-80s ...Continue Reading

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Jun 30, 2009·Investigative Radiology·Narasimharao BhagavathulaJames Varani
Jul 28, 2010·Investigative Radiology·Benjamin WiesingerJakub Wiskirchen

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Citations

Jan 27, 2016·Advances in Therapy·Jessica LohrkeHubertus Pietsch
Jan 26, 2011·Investigative Radiology·Nathalie FretellierClaire Corot
Jul 28, 2010·Investigative Radiology·Benjamin WiesingerJakub Wiskirchen
Nov 9, 2010·Investigative Radiology·Val M Runge

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