The US Food and Drug Administration (FDA) is looking into the risk for brain deposits with repeated use of gadolinium-based contrast agents (GBCAs) for MRI, the agency said today in a drug safety communication.
Following administration, GBCAs are mostly eliminated from the body through the kidneys. However, recent reports suggest that GBCAs can linger in the brains of patients who undergo four or more contrast MRI scans as part of management of multiple sclerosis, cancer, or other illnesses, even in those with normal kidney function, the FDA says.
It's not known whether these deposits are harmful or can lead to adverse health effects. "To date, no signs or symptoms of adverse health effects and no pathological changes have been associated with these gadolinium deposits in the brain," the FDA notes.
However, they do err on the side of caution in their recommendation. "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," the FDA advises.
http://www.medscape.com/viewarticle/848668?src=wnl_edit_newsal&uac=60196BR&impID=773073&faf=1
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The FDA did not announce any label changes for the nine medicines that contain the metal, gadolinium, saying there was a “need for additional information.” However, “to reduce the potential for gadolinium accumulation,” the safety announcement asked health-care professionals to “consider limiting” their use and to re-examine “the necessity of repetitive” MRIs involving these drugs.
ReplyDeleteProPublica has extensively reported on the potential risks of contrast agents, including a call by two prominent radiologists for more research following recent studies that unexpectedly found gadolinium in the brain tissues of patients. The patients each underwent at least four scans using two of the nine agents currently on the market. It is not known if the deposits are harmful.
Gadolinium-based contrast agents have been on the market for a few decades and enhance the scanned images. About one-third of the 20 million MRIs in the United States each year use one of the nine agents. The FDA’s call to doctors to limit use of the agents seeks to make sure the “additional information provided by the contrast is necessary.”
Normally, the gadolinium is largely eliminated from the body via the kidneys following the drug’s injection. As such, patients are screened to ensure they do not have kidney disease. But the recent studies found that gadolinium can remain in the brain even in patients whose kidneys function normally.
In the past, the FDA has been slow to move in this area.
In 2007, it ignored the advice of two of its medical reviewers who wanted to ban one of the drugs, Omniscan, made by GE Healthcare, for patients with severe kidney disease. In 2010 the agency reversed course and recommended that Omniscan and two other drugs shouldn’t be used in patients with impaired kidneys. The other drugs were Magnevist, made by Bayer HealthCare, and Optimark, sold by Mallinckrodt Pharmaceuticals.
http://www.psmag.com/#!/health-and-behavior/the-fda-examines-whether-mri-drugs-accumulate-in-brain-tissue
[5-22-2017] A U.S. Food and Drug Administration (FDA) review to date has not identified adverse health effects from gadolinium retained in the brain after the use of gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI). All GBCAs may be associated with some gadolinium retention in the brain and other body tissues. However, because we identified no evidence to date that gadolinium retention in the brain from any of the GBCAs, including GBCAs associated with higher retention of gadolinium, is harmful, restricting GBCA use is not warranted at this time. We will continue to assess the safety of GBCAs and plan to have a public meeting to discuss this issue in the future.
ReplyDeleteOur recommendations for health care professionals and patients remain unchanged from July 2015 when we informed the public that we were investigating this potential risk with GBCAs. As is appropriate when considering the use of any medical imaging agent, health care professionals should limit GBCA use to circumstances in which additional information provided by the contrast agent is necessary, and assess the necessity of repetitive MRIs with GBCAs. Patients, parents, and caregivers should talk to their health care professionals if they have any questions or concerns about the use of GBCAs with MRIs. Retention of gadolinium affects only GBCAs, and does not apply to other types of scanning agents used for other imaging procedures, such as those that are iodine-based or radioisotopes.
https://www.fda.gov/downloads/Drugs/DrugSafety/UCM559654.pdf