Information on Gadolinium-Based Contrast Agents
Gadolinium-Based Contrast Agents (GBCA) are intravenous drugs used in diagnostic imaging procedures to enhance the quality of magnetic resonance imaging (MRI) or magnetic resonance angiography (MRA).
Magnetic Resonance Imaging (MRI) is a medical imaging procedure for making images of the internal structures of the body. MRI scanners use strong magnetic fields and radio waves (radiofrequency energy) to make images. The signal in an MR image comes mainly from the protons in fat and water molecules in the body.
During an MRI exam, an electric current is passed through coiled wires to create a temporary magnetic field in a patient’s body. Radio waves are sent from and received by a transmitter/receiver in the machine, and these signals are used to make digital images of the scanned area of the body. A typical MRI scan last from 20 - 90 minutes, depending on the part of the body being imaged.
For some MRI exams, intravenous (IV) drugs, such as gadolinium-based contrast agents (GBCAs) are used to change the contrast of the MR image. Gadolinium-based contrast agents are rare earth metals that are usually given through an IV in the arm.
For more information about MRI and their safety and risks, please see the Center for Radiological Health’s consumer information page.
To report any unexpected adverse or serious events associated with the use of this drug, please contact the FDA MedWatch program listed below.
Report a Serious Problem
Regular Mail: Use postage-paid FDA Form 3500
Mail to: MedWatch 5600 Fishers Lane
Rockville, MD 20857
- FDA Drug Safety Communication: FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warnings
- FDA Drug Safety Communication: FDA identifies no harmful effects to date with brain retention of gadolinium-based contrast agents for MRIs; review to continue
- 2017 Meeting Materials, Medical Imaging Drugs Advisory Committee
- FDA Drug Safety Communication: FDA evaluating the risk of brain deposits with repeated use of gadolinium-based contrast agents for magnetic resonance imaging (MRI)
- FDA Drug Safety Communication New recommendations for using gadolinium-based contrast agents in patients with kidney dysfunction
- FDA: New warnings required on use of gadolinium-based contrast agents
- Update on Magnetic Resonance Imaging (MRI) Contrast Agents Containing Gadolinium and Nephrogenic Fibrosing Dermopathy
- Questions and Answers on Gadolinium-Based Contrast Agents
Regulatory History and Labeling from Drugs@FDA
Gadolinium-Based Contrast Agents: