FDA WARNINGS

June 8, 2006: First Public Health Advisory issued by the FDA about the risk of NSF from gadolinium dyes. This was after they received reports of 25 patients with NSF from the Danish health authority. (See FDA Gadolinium Alert June 2006)

December 22, 2006: Second gadolinium warning was issued.

The FDA released information that patients with moderate renal insufficiency were at risk of developing NSF. It turns out that this was a mistake. These patients only appear to be at risk if they also have liver transplantation or chronic liver disease. There have been no reports of NSF in patients with normal renal functioning.

May 23, 2007: The FDA ordered that a black box warning and other warnings be added to all GBCA labels about the life-threatening risks associated with GBCA use. Detailed information was provided to healthcare providers in the Information for Healthcare Professionals. Following are excerpts from the FDA Press Release:

The requested warning would state that patients with severe kidney insufficiency who receive gadolinium based agents are at risk for developing a debilitating, and a potentially fatal disease known as nephrogenic systemic fibrosis (NSF). In addition, it would state that patients just before or just after liver transplantation, or those with chronic liver disease, are also at risk for developing NSF if they are experiencing kidney insufficiency of any severity. ...

Reports have identified the development of NSF following single and multiple administrations of the gadolinium-based contrast agents. ... Omniscan was the most commonly reported agent, when a specific agent was identified, followed by Magnevist and OptiMARK.

...Because reports incompletely describe exposure to gadolinium based contrast agents, it is not possible to know if the extent of risks for developing NSF is the same for all agents.