Friday the FDA finalized the its announcement made in May that it would add the “black box” warnings to gadolinium based contrast agents used to enhance magnetic resonance imaging (MRI). These contrast agents have been linked to rare skin disease known as nephrogenic systemic fibrosis (NSF). This is very serious disease characterized by the thickening of the skin and even internal tissue and organs. The warning will be aimed at patients with particular liver and kidney conditions that elevate their risk of developing NSF.
Although risks associated with individual agents is yet to be determined, a study estimates a 4 percent fisk of NSF associated with patients with severe renal failure that receive one of the five FDA approved gadolinium based agents.
Patients should be screened for kidney problems before use of such agents, the letter said, adding that the recommended dose should not be exceeded.
The new “black box” warning is the highest level warning that can be issue by the FDA and should make a big impression on the medical community, hopefully sparing patients from this horrible skin condition.
For more information on this subject, please refer to the section on Drugs, Medical Devices, and Implants.