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Boxed Warning Added to Gadolinium Due to NSF Adverse Reactions
Manufacturers of Gadolinium-based contrast agents issued a Dear Healthcare Professional letter to inform healthcare professionals of the addition of the Food and Drug Administrations most stringent "boxed warning" due to NSF adverse reactions.
Additionally, the agency has made revisions to the Warning section of the prescribing information for Gadolinium-based contrast agents used in Magnetic Resonance Imaging (MRI).
Gadolinium-based contrast agents have been linked to the development of Nephrogenic Systemic Fibrosis in some patients with pre-existing kidney disease.
NSF is a rapidly progressive, debilitating skin condition that can affect internal organs and, in some cases, result in death.
If you have developed Nephrogenic Systemic Fibrosis or Nephrogenic Fibrosing Dermopathy (NSF/NFD) following an MRI/MRA, you deserve the guidance of a lawyer experienced in such cases. Please complete the form below for a free legal evaluation.
see also:
FDA Responds
FDA Notifies Doctors and Patients on Gadolinium in MRI ProceduresFDA Responds to Reports of NSF/NFD Related to Gadolinium in MRI Tests
Boxed Warning
Boxed Warning Added to Gadolinium Due to NSF Adverse ReactionsNSF Reactions Spur Boxed Warning, New Warning Label on Gadolinium
FDA Warnings
FDA Requests Boxed Warning for Gadolinium Dye Used with MRIsFDA Warning: "Black Box" to Be Placed on MRI Dyes with Gadolinium
