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May 23, 2007—The FDA announced today that it is asking manufacturers of gadolinium-based contrast agents to include a black box warning alterting patients to the risk of a potentially fatal disease.
The FDA stated that patients with kidney disease or chronic liver disease are at risk for developing nephrogenic systemic fibrosis, a disease characterized by a thickening of the skin and connective tissues that inhibit their ability to move.
The following gadolinium-based agents are implicated by the warning:
- Magnevist (gadopentetate dimeglumine)
- Omniscan (gadodiamide)
- OptiMARK (gadoversetamide)
- MultiHance (gadobenate dimeglumine)
- ProHance (gadoteridol)
The FDA has been aware of problems with gadolinium since at least June 2006, when the agency warned healthcare professionals about the risk of nephrogenic systemic fibrosis. A subsequent warning was issued in December 2006.
The FDA stated it has received 128 reports of nephrogenic systemic fibrosis in patients who used gadolinium-based agents. |