FDA ALERTS AND BLACK BOX WARNINGS
The FDA first notified health care professionals and the public about the gadolinium-related risks for NSF on June 8, 2006 after 25 cases of NSF/NFD were reported on May 29, 2006, by the Danish Medicines Agency. Among these, 20 cases occurred in Denmark and five cases occurred in Austria. The patients developed NSF/NFD within 3 months (range 2 weeks to 3 months) after receiving the gadolinium-containing contrast agent. By of April 3, 2007, the Food and Drug Administration has received another 65 cases of Nephrogenic Systemic Fibrosis/Nephrogenic Fibrosing Dermopathy (NSF/NFD). By December 2007, the FDA ordered the most serious warning label to be placed on gadolinium based contrast dyes. It reads:
Text of Black Box Warning:
Exposure to GBCAs increases the risk for NSF in patients with: acute or chronic severe renal insufficiency (glomerular filtration rate less than 30 mL/min/1.73m2), or acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period.
NSF is a debilitating and sometimes fatal disease affecting the skin, muscle, and internal organs. Avoid use of GBCAs unless the diagnostic information is essential and not available with non-contrast enhanced magnetic resonance imaging (MRI). Screen all patients for renal dysfunction by obtaining a history and/or laboratory tests. When administering a GBCA, do not exceed the dose recommended in product labeling. Allow sufficient time for elimination of the GBCA prior to any re-administration.
Contact Colorado Gadolinium Attorney, Beth Klein for help with your case
If you or someone you know has developed NSF or NFD symptoms after having an MRI or MRA, contact our firm for a FREE EVALUATION by one of our lead attorneys and consulting physician.
Our firm represents people across the country who have been injured by gadolinium contrast dyes. It is a key commitment of this firm to establish and maintain a close attorney client relationship with all of our clients. We want to be able to spend significant time with our clients and their families so that we can fully represent them and give them their voice in their cases. These cases are about their lives, their hope, their sorrow and loss, and their opportunity for healing and justice. We hope we can help you.
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