What information was known about serious side effects prior to the approval of gadolinium-based contrast agents?
The five U.S. approved GBCAs were approved between 1988 and 2004. In the combined pre-marketing studies for these approved GBCAs, over 3000 patients were studied. The most common serious side effect from GBCAs is an allergic reaction that is usually mild but is occasionally severe and even results in fatalities. Some patients develop skin conditions, such as rash, sweating, itching, hives, and facial swelling. GBCAs can be very irritating to the veins into which they are injected, causing irritation of blood vessels and skin and the formation of blood clots. Very few patients with severely compromised kidney function or those on dialysis have been studied in clinical trials. The labels for GBCAs caution that the risk of toxic reactions may be greater in patients with impaired kidney function because gadolinium is mostly excreted by the kidney.
Related Questions
- Has Nephrogenic Systemic Fibrosis (NSF) been reported with all of the U.S.-approved gadolinium-based contrast agents?
- What information was known about serious side effects prior to the approval of gadolinium-based contrast agents?
- What diseases have been associated with gadolinium-based contrast agents?
