FDA Announces Black Box Warning on Gadolinium-Based Agents

by Administrator 5. August 2010 06:27
The United States Food and Drug Administration announced that it is asking manufacturers of gadolinium-based contrast agents to include a black box warning.

According to a statement released by the FDA, patients with kidney disease or chronic liver disease are at risk for developing nephrogenic systemic fibrosis when exposed to gadolinium-based contrast agents. Five contrast agents are implicated by the black box warning: Magnevist, Omniscan, OptiMARK, MultiHance, and ProHance.

The FDA has been aware of problems with gadolinium since June 2006, when the agency warned healthcare professionals about the risk of nephrogenic systemic fibrosis. A subsequent warning was issued in December 2006.

If you have developed NSF because of gadolinium-based agents, you may be eligible for compensation. Contact a gadolinium lawyer of Williams Kherkher by calling 800-761-3187.

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