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FDA requests boxed warning on gadolinium agents, prompts criticism

This article was originally published in Clinica

Executive Summary

All US FDA-approved gadolinium-based MRI contrast agents (GBMCAs) are to feature a boxed warning on their labelling at the agency's request, to caution physicians about the potential adverse effects of such agents in severe kidney disease patients. The move has prompted mixed reactions from observers. Chairman of the American College of Cardiology (ACR) blue ribbon panel on MR safety, Emanuel Kanal, feels that the FDA's warning request "omits important facts", regarding the higher prevalence of certain agents, notably GE's Omniscan, in causing the debilitating and potentially fatal disease nephrogenic systemic fibrosis (NSF). GBMCAs have now been implicated in over 200 cases of NSF.

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