PATIENT INFORMATION ON GADOLINIUM CONTRAST AGENTS
Your doctor has ordered an MRI exam. Depending on the exam, you may need a GBCA, or Gadolinium-Based Contrast Agent, through an injection or IV. This GBCA is important in some cases for our radiologists, who read the MRI exam, to find certain health conditions earlier and/or more accurately than doing the exam without it.
GBCA’s have been in use clinically in the USA for 30 years, and hundreds of millions of doses given to patients around the world since 1988 when it was first developed and approved for use in humans diagnostically.
GBCA’s can be either linear or macrocyclic. Linear agents retain more gadolinium in the brain than macrocyclic. At Metro MRI, we utilize a macrocyclic agent called Gadavist or Gadobutrol. Gadavist is made to be eliminated by the body more easily and efficiently, plus the dosage needed is less than with other GBCA’s, making it the safer contrast of choice by our Radiologist’s.
Furthermore, the FDA has approved Gadavist for use in the following MRI studies:
Magnetic Resonance Angiography (MRA) to evaluate supra-aortic or renal artery disease in adults, children, as well as term neonates
MRI of the breast to assess the presence and/or extent of malignant breast disease
MRI to detect and visualize areas with disrupted blood brain barrier and/or abnormal vasculature of the central nervous system in adults, children, and term neonates
The FDA Information on Gadolinium-Based Contrast Agents and their Medication Guides are available at:
The US Food and Drug Administration (FDA) have evaluated scientific publications and adverse event reports pertaining to GBCA’s. These show that a very small amount of gadolinium remains in organs such as the brain, bones and skin. It is not known how gadolinium may affect you, but so far, studies have not found harmful effects in patients with normal kidney function. Rarely, patients have reported pains, tiredness, and skin, muscle or bone ailments for a long time, but these symptoms have not been directly linked to gadolinium.
Recent research has shown that patients with renal insufficiency cannot filter the gadolinium from their body, so the FDA includes a warning label on the contrast packaging. There is however little evidence showing patient safety issues who have normal kidney function. Warning labels are also included for those patients with allergy disorders.
The FDA stated there is no clinical evidence that directly links gadolinium retention to adverse health effects in patients with normal kidney function, and the FDA has concluded that the benefit of all approved GBCA’s continues to outweigh any potential risks.
One possible risk for those with non-optimal kidney function is nephrogenic systemic fibrosis. According to the Mayo Clinic:
“Gadolinium-containing contrast agents may increase the risk of a rare but serious disease called nephrogenic systemic fibrosis in people with severe kidney failure. Nephrogenic systemic fibrosis triggers thickening of the skin, organs and other tissues. Before you have an MRI, make sure your doctor knows about your kidney problems. Blood tests can reveal how severely your kidney function is impaired, which can help determine your risk of nephrogenic systemic fibrosis. If your doctor still recommends an MRI with gadolinium despite the potential risks, you may be given the lowest possible dose of the form of gadolinium that’s been associated with the fewest complications. Your doctor also may recommend hemodialysis-a procedure that filters wastes from your blood via a machine-immediately after the MRI.”
GBCA’s help distinguish or “contrast” certain structures or tissues in the body by making them appear differently on images than if no contrast agent had been administered. Radiologists are then able to distinguish normal from abnormal conditions. Contrast material in not only important for diagnosis and exclusion of many abnormal conditions, but it is also necessary for monitoring treatment response and seeing the extent of disease.
For more information you may visit these websites:
Patients who are considering a MRI, that may involve contrast material, may visit the Contrast Materials section of RadiologyInfo.org website. RadiologyInfo.org is a public website that was created by the American College of Radiology (ACR) and the Radiological Society of North America. It provides information that may answer a great many questions about medical imaging exams and related procedures, the role of the radiologists in healthcare, and to improve communication between health care professionals and their patients.
The information on this website is intended for your general knowledge only and is not a substitute for professional medical advice; please consult your healthcare provider with any questions or concerns about the use of GBCAs with MRIs.
You are encouraged to report negative side effects or quality complaints of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see full prescribing information at http://labeling.bayerhealthcare.com/html/products/pi/gadavist_PI.pdf
Emanuel Kanal, M.D., director of MRI services and professor of radiology and neuroradiology at the University of Pittsburgh Medical Center
American College of Radiology (ACR) Manual on Contrast Media Version 10.2 2016
Bae S, Lee HJ, Han K,Park YW, Choi YS, Ahn SS, et al. Gadolinium deposition in the brain: association with various GBCAs using a generalized additive model. Eur Radiol 2017 Jan 12. doi: 10.1007/s00330-016-4724-5. [Epub ahead of print].
Girardi M, Kay J, Elston DM, Leboit PE, Abu-Alfa A, Cowper SE. Nephrogenic systemic fibrosis: clinicopathological definition and workup recommendations. J Am Acad Dermatol 2011;65:1095-106.
Gathings RM, Reddy R, Cruz DS, Brodell RT. Gadolinium-associated plaques: a new, distinctive clinical entity. JAMA Dermatol 2015;151:316-9.
Hu HH, Pokorney A, Towbin RB, Miller JH. Increased signal intensities in the dentate nucleus and globus pallidus on unenhanced T1-weighted images: evidence in children undergoing multiple gadolinium MRI exams. Pediatr Radiol 2016;46:1590-8.
Kahn J, Posch H, Steffen IG, Geisel D, Bauknecht C, Liebig T, et al. Is there long-term signal intensity increase in the central nervous system on T1-weighted images after MR imaging with the hepatospecific contrast agent gadoxetic acid? a cross-sectional study in 91 patients. Radiology 2017;282:708-16.
Ichikawa S, Motosugi U, Omiya Y, Onishi H. Contrast agent-induced high signal intensity in dentate nucleus on unenhanced T1-weighted images: comparison of gadodiamide and gadoxetic acid. Invest Radiol 2017 Feb 11. doi: 10.1097/RLI.0000000000000360. [Epub ahead of print].
Miller JH, Hu HH, Pokorney A, Cornejo P, Towbin R. MRI brain signal intensity changes of a child during the course of 35 gadolinium contrast examinations. Pediatrics 2015;136:e1637-40.
Roberts DR, Holden KR. Progressive increase of T1 signal intensity in the dentate nucleus and globus pallidus on unenhanced T1-weighted MR images in the pediatric brain exposed to multiple doses of gadolinium contrast. Brain Dev 2016;38:331-6.
Maximova N, Gregori M, Zennaro F, Sonzogni A, Simeone R, Zanon D. Hepatic gadolinium deposition and reversibility after contrast agent-enhanced MR imaging of pediatric hematopoietic stem cell transplant recipients. Radiology 2016;281:418-426.
Murata N, Gonzalez-Cuyar LF, Murata K, Fligner C, Dills R, Hippe D, et al. Macrocyclic and other non-group 1 gadolinium contrast agents deposit low levels of gadolinium in brain and bone tissue: preliminary results from 9 patients with normal renal function. Invest Radiol 2016;51:447-53.
Murata N, Murata K, Gonzalez-Cuyar LF, Maravilla KR. Gadolinium tissue deposition in brain and bone. Magn Reson Imaging 2016;34:1359-1365.
Roberts DR, Lindhorst SM, Welsh CT, Maravilla KR, Herring MN, Braun KA, et al. High levels of gadolinium deposition in the skin of a patient with normal renal function. Invest Radiol 2016;51:280-9.
Burke LM, Ramalho M, AlObaidy M, Chang E, Jay M, Semelka RC. Self-reported gadolinium toxicity: A survey of patients with chronic symptoms. Magn Reson Imaging 2016;34:1078-80.
Semelka RC, Ramalho J, Vakharia A, AlObaidy M, Burke LM, Jay M, et al. Gadolinium deposition disease: initial description of a disease that has been around for a while. Magn Reson Imaging 2016;34:1383-90.
Semelka RC, Ramalho M, AlObaidy M, Ramalho J. Gadolinium in humans: A family of disorders. AJR Am J Roentgenol 2016;207:229-33.
Semelka RC, Commander CW, Jay M, Burke LM, Ramalho M. Presumed gadolinium toxicity in subjects with normal renal function: a report of 4 cases. Invest Radiol 2016;51:661-5.
Malayeri AA, Brooks KM, Bryant LH, Evers R, Kumar P, Reich DS, et al. National Institutes of Health perspective on reports of gadolinium deposition in the brain. J Am Coll Radiol 2016;13:237-41.
European Medicines Agency. Gadolinium-containing contrast agents. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Gadolinium-containing_contrast_agents/human_referral_prac_000056.jsp&mid=WC0b01ac05805c516f . Published March 10, 2017; updated April 7, 2017. Accessed May 9, 2017.
Bayer: Science For A Better Life
Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their lives. At the same time, the Group aims to create value through innovation, growth and high earning power. Bayer is committed to the principles of sustainable development and to its social and ethical responsibilities as a corporate citizen. In fiscal 2015, the Group employed around 117,000 people and had sales of EUR 46.3 billion. Capital expenditures amounted to EUR 2.6 billion, R&D expenses to EUR 4.3 billion. These figures include those for the high-tech polymers business, which was floated on the stock market as an independent company named Covestro on October 6, 2015. For more information, go to www.bayer.us.