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CMSC INforMS: FDA: Gadolinium-based MRI Contrast Agents Pose Possible Brain Risk

Tuesday, July 28, 2015   (0 Comments)
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A statement from our CMSC leadership:
While the implications for MS patient care may need to be re-evaluated and changed in the future based on further studies of the possible safety risk of the deposits of gadolinium-based contrast agents (GBCAs) remaining in the brains of some patients who undergo repeated MRI scans, because currently available information does not identify any adverse health effects and because of the important benefit from the use of GBCAs in providing information regarding MS lesion activity, the use of GBCAs should remain a key and vital component of the MRI examination for the diagnosis and follow-up of patients with MS.

The FDA stated that clinicians should consider limiting GBCA use to clinical circumstances in which the additional information provided by the contrast is necessary and reassess the necessity of repetitive GBCA MRIs in established treatment protocols.




FDA: Gadolinium-based MRI Contrast Agents Pose Possible Brain Risk

The US 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). Recent publications in the medical literature have reported that deposits of GBCAs remain in the brains of some patients who undergo four or more contrast MRI scans, long after the last administration. It is unknown whether these gadolinium deposits are harmful or can lead to adverse health effects.

The FDA, will study this possible safety risk further. The FDA is 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, FDA is not requiring manufacturers to make changes to the labels of GBCA products. Recent studies conducted in people and animals have confirmed that gadolinium can remain in the brain, even in individuals with normal kidney function. Available information does not identify any adverse health effects.

The FDA recommends that 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.

Health care professionals are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

Source: American Academy of Neurology



A statement from our CMSC leadership:
While the implications for MS patient care may need to be re-evaluated and changed in the future based on further studies of the possible safety risk of the deposits of gadolinium-based contrast agents (GBCAs) remaining in the brains of some patients who undergo repeated MRI scans, because currently available information does not identify any adverse health effects and because of the important benefit from the use of GBCAs in providing information regarding MS lesion activity, the use of GBCAs should remain a key and vital component of the MRI examination for the diagnosis and follow-up of patients with MS.

The FDA stated that clinicians should consider limiting GBCA use to clinical circumstances in which the additional information provided by the contrast is necessary and reassess the necessity of repetitive GBCA MRIs in established treatment protocols.




CMSC Disclaimer
The industry news information and articles are for informational purposes only, and are not intended to represent any trends, partnerships, commitments, or research of the Consortium of MS Centers or any of it's members in any way whatsoever, nor should any party be libel in any way to the reader or to any other person, firm or corporation reading this industry news section. Although the CMSC site includes links providing direct access to other Internet sites, CMSC takes no responsibility for the content or information contained on those other sites, and does not exert any editorial or other control over those other sites. CMSC is providing information and services on the Internet as a benefit and service in furtherance of CMSC's nonprofit and tax-exempt status. CMSC makes no representations about the suitability of this information and these services for any purpose.


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