Dear AuntMinnie Member,
The U.S. Food and Drug Administration (FDA) today issued new rules on the labeling of gadolinium-based contrast agents (GBCAs) for MRI scans. The FDA now wants GBCA manufacturers to include new labeling information on gadolinium retention in product packaging, and it wants healthcare providers who order contrast to consider that residual gadolinium could be retained in patients after MRI scans are performed.
The FDA's move puts into action recommendations made in September by the agency's Medical Imaging Drugs Advisory Committee, which voted in favor of adding a warning about gadolinium retention to the labeling of GBCA products. But it's likely to disappoint patient advocates, who want the FDA to take stronger action and even pull some gadolinium products from the market. Read more about the FDA's move today by clicking here.
The process of pulling some GBCA agents from the market is already underway in Europe. The U.K. Medicines and Healthcare products Regulatory Agency last week announced that it was ordering the withdrawal of two linear gadolinium agents by February. The move implements a directive ordered by the European Medicines Agency, which has told member states they have a year to pull several linear GBCAs from the market due to concerns about gadolinium retention. Learn more about the U.K. action by clicking here for a story on our AuntMinnieEurope.com sister site.
X-ray fluorescence to detect gadolinium
Meanwhile, Canadian researchers say they may have developed a solution to one of the trickier dilemmas in the gadolinium controversy: detecting retained gadolinium in living patients. They have developed a technique that uses x-ray fluorescence technology to detect trace elements of gadolinium in patients who have received GBCA contrast.
In a pilot study of the technology in 22 individuals, the approach was able to detect minute amounts of gadolinium in the bones of people who had received a GBCA -- even five years after a contrast injection. Learn more about how it works by clicking here, or visit our MRI Community at mri.auntminnie.com.
