FDA Reveals Risk of NSF from Gadolinium-FDA Reveals Risk of NSF from Gadolinium
In learning that a handful of patients with pre-existing kidney problems developed a serious condition called Nephrogenic Systemic Fibrosis (NSF), the FDA issued a letter of warning in 2006 informing healthcare professionals about the addition of a boxed warning for Gadolinium-based contrast agents, commonly used in MRIs (magnetic resonance imaging). The FDA announcement also included new warnings about the danger of NSF.
Previously referred to as Nephrogenic Fibrosing Dermopathy, NSF is a skin condition that, although currently under peer review, occurs only in individuals with kidney disease. The reason for this is that gadolinium (a heavy metal ion) is capable of staying in a person’s system unless the kidneys are able to get rid of it.
The International Center for Nephrogenic Systemic Fibrosis Research defines the condition as large areas of solidified or hardened skin. An affected area may contain raised papules, plaques, or confluent papules, which may raise skin deposits of mucous or display pigmentary variation. As a consequence of NSF, some patients lose the ability to entirely extend the joints of their feet, arms, legs, and hands, and may not be able to walk.
The FDA has warned physicians to screen patients for kidney problems before injecting Gadolinium based contrast agents during MRIs. The FDA also raised awareness of the risks of NSF posed by three Gadolinium agents, specifically Magnevist (marketed by Bayer Shering Pharma), OptiMark (manufactured by Mallinckrodt, Inc.), and Ominiscan (made by GE Healthcare).
A patient who has suffered NSF after receiving Gadolinium-based contrast agents for an MRI does have legal rights and options. If you have contracted NSF or any other condition after undergoing an MRI in Missouri, the St. Louis injury attorneys at Page Cagle can help. Call 866-620-5757 today for a free consultation and to learn more about what can be done to help you obtain compensation.
Source reports: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm152672.htm; http://www.icnfdr.org/
