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MultiHance found to leave residual gadolinium in the brain
A new study by Weberling et al, Increased Signal Intensity in the Dentate Nucleus on Unenhanced T1-Weighted Images after Gadobenate Dimeglumine Administration, found increased signal intensity (SI) in the dentate nucleus (DN) after serial injections of the linear gadolinium-based contrast agent (GBCA) gadobenate dimeglumine (MultiHance, Bracco Diagnostics Inc.). The study included 50 patients that had a minimum of 5 consecutive brain MRI scans with MultiHance. All MRIs were performed between March 1, 2014 and December 31, 2014 in the German Cancer Research Center, Heidelberg, Germany. 45 of the patients had an estimated glomerular filtration rate (eGFR) greater than 60, and 5 had an eGFR between 45 and 60.
Like the 2015 study by Radbruch et al, the exclusion criteria included: history of brain hemorrhage, stroke, or brain ischemia; edema, tumor, or other lesions located in the cerebellum or pons; history of intracranial infection, such as meningitis or encephalitis; missing or unsatisfactory unenhanced T1-weighted MRI scans; and missing documentation of the contrast agent administered.
The study found an increased SI in the DN-to-CSF (cerebrospinal fluid) and DN-to-pons ratios on unenhanced T1-weighted images in patients that had at least 5 MRIs with the gadolinium-based contrast agent MultiHance. The authors said, “Because the previous work by McDonald et al showed that SI correlates with gadolinium retention in the respective area, the SI increase found herein likely reflects the specific potential of gadobenate dimeglumine to release gadolinium”. (more…)
Radiologists are in best position to watch patients’ backs
An August 1, 2015 article by Richard Dargan, Radiology Society of North America (RSNA), reviewed recent studies that reported finding evidence of gadolinium retention in the brains of patients with normal renal function. The article, “Radiology Should Take Lead in MRI Contrast Media Use, Research”, also included comments from Emanuel Kanal, M.D., regarding the role radiologists should play in MRI contrast agent research and usage. Dr. Kanal, a Professor of Radiology at the University of Pittsburgh Medical Center (UPMC), chairman of the American College of Radiology MR Safety Committee from 2002-2012, and chairman of the new American Board of Magnetic Resonance Safety (ABMRS), made his comments in an interview with RSNA News.
Recent research has shown that gadolinium-based-contrast agents (GBCAs) are leaving residual gadolinium in the brains of patients, including patients with normal renal function. Two regions in particular have been affected: the dentate nucleus and the globus pallidus. A 2013 study by Kanda et al, first reported finding high signal intensity in those two brain regions on unenhanced T1-weighted magnetic resonance (MR) images that appeared to be related to the increasing cumulative dose of a gadolinium-based contrast agent. Since then, additional studies have been published which confirmed the increased signal intensity is the result of gadolinium accumulation within the brain. (more…)
FDA announces it is investigating risk of Brain Deposits of Gadolinium from Contrast MRIs
Today, July 27, 2015, the FDA issued its initial Safety Announcement concerning possible safety risks caused by brain deposits of Gadolinium following repeated use of Gadolinium-based contrast agents for MRIs. A link to the document on the FDA website is provided below. The following is the FDA’s Safety Announcement:
FDA Drug Safety Communication: FDA evaluating the risk of brain deposits with repeated use of gadolinium-based contrast agents for magnetic resonance imaging (MRI)
[7-27-2015]Safety Announcement
The U.S. Food and Drug Administration (FDA) is investigating the risk of brain deposits following repeated use of gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI). MRIs help detect abnormalities of body organs, blood vessels, and other tissues. Recent publications in the medical literature have reported that deposits of GBCAs (See Table 1) remain in the brains of some patients who undergo four or more contrast MRI scans, long after the last administration.1-21 It is unknown whether these gadolinium deposits are harmful or can lead to adverse health effects.
FDA, including its National Center for Toxicological Research (NCTR), will study this possible safety risk further. We are working with the research community and industry to understand the mechanism of gadolinium retention and to determine if there are any potential adverse health effects. Based on the need for additional information, at this time, we are not requiring manufacturers to make changes to the labels of GBCA products.
To reduce the potential for gadolinium accumulation, health care professionals should consider limiting GBCA use to clinical circumstances in which the additional information provided by the contrast is necessary. Health care professionals are also urged to reassess the necessity of repetitive GBCA MRIs in established treatment protocols.
Patients, parents, and caregivers should talk to their health care professionals if they have any questions about the use of GBCAs with MRIs. This issue affects only GBCAs; it does not apply to other types of scanning agents used for other imaging procedures, such as those that are iodine-based or radioisotopes.
After being administered, GBCAs are mostly eliminated from the body through the kidneys. However, trace amounts of gadolinium may stay in the body long-term. Recent studies conducted in people and animals have confirmed that gadolinium can remain in the brain, even in individuals with normal kidney function.1-21 Available information does not identify any adverse health effects.
We urge health care professionals, patients, and parents/caregivers to report possible side effects involving GBCAs to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.
The list of approved GBCAs (Table 1), Data Summary, and References included with this FDA Communication can be found here: http://www.fda.gov/Drugs/DrugSafety/ucm455386.htm
Patients who believe they have been adversely affected by an MRI contrast agent should report their experience to the FDA using its MedWatch Adverse Event Reporting System which can be found here: http://www.fda.gov/Safety/MedWatch/default.htm
NSF Diagnosis made 10 years after patient’s last dose of contrast
On May 27, 2015, JAMA Dermatology published a Case Report by Larson et al that described a biopsy-confirmed case of “Nephrogenic Systemic Fibrosis Manifesting a Decade after Exposure to Gadolinium”. According to the report, a long-term hemodialysis patient was exposed to a gadolinium-based contrast agent several times between 1998 and 2004 during magnetic resonance angiography (MRA) of his abdominal vessels and arteriovenous fistula. Ten years later, in 2014, he developed new dermal papules and plaques. The diagnosis of NSF was made based on the findings of a biopsy of affected skin which showed thickening of collagen, CD34+ spindle cells, and increased mucin in the dermis. (Information about the agent(s) and dosages are not provided).
Prior to this case, the authors noted that the longest documented time after exposure to gadolinium to NSF manifestation was 3 ½ years.
This case shows that even in patients with severe renal disease retained gadolinium can take many years before causing “visible” evidence of a problem. The authors concluded that, “Although the use of gadolinium contrast agents in patients with kidney failure has markedly decreased, patients with exposure to gadolinium years to decades previously may manifest the disease”. (more…)
Gadolinium Toxicity 