FDA, Bayer issue letter to doctors about MRI agents.Bayer Healthcare and FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. issued a "Dear Healthcare Professional" letter to notify of the addition of a BOXED WARNING and revisions to the WARNING section of the prescribing information for Gadolinium-based contrast agents used in Magnetic Resonance Imaging magnetic resonance imaging (MRI), noninvasive diagnostic technique that uses nuclear magnetic resonance to produce cross-sectional images of organs and other internal body structures. (MRI), the agency stated Sept. 28.
Gadolinium-based contrast agents are approved by FDA for use in MRI. Post-marketing reports show that the use of these agents increases the risk of the development of a serious medical condition called Nephrogenic nephrogenic /neph·ro·gen·ic/ (-jen´ik) producing kidney tissue.
producing kidney tissue. Systemic Fibrosis (NSF), in patients with acute or chronic severe renal insufficiency and patients with renal dysfunction due to the hepatorenal syndrome or in the perioperative liver transplantation period.
NSF leads to excessive formation of connective tissue in the skin and internal organs. NSF is progressive and may be debilitating de·bil·i·tat·ing
Causing a loss of strength or energy.
Weakening, or reducing the strength of.
Mentioned in: Stress Reduction or fatal. FDA has received reports of over 250 cases of NSF after administration of gadolinium-based contrast agents, the agency reported
As a result of these NSF cases, the package inserts of all gadolinium-based contrast agents have been revised to include the following Boxed Warning and update to the Warnings section.
The MedWatch 2007 Safety Summary including a link to the Dear Healthcare Professional letter and the revised labeling is available at:: http://www.fda.gov/medwatch/safety/2007/safety07.h tm#Gadolinium gadolinium (gădəlĭn`ēəm), metallic chemical element; symbol Gd; at. no. 64; at. wt. 157.25; m.p. 1,312°C;; b.p. 3,233°C;; sp. gr. 7.898 at 25°C;; valence +3.