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May 24, 2007

Stronger Warnings for Gadolinium-Based Contrast Agents

The Food and Drug Administration has requested that makers of all gadolinium-based contrast agents (GBCAs) add new warnings, including a "black box" warning about the risk of nephrogenic systemic fibrosis (NSF). Brand names affected by the new warnings include: Magnevist, MultiHance, Omniscan, OptiMARK, and ProHance. A black box warning is the strongest warning the FDA can mandate.

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