Author Topic: FDA says restricting MRI contrast agents "not warranted"  (Read 13 times)

0 Members and 0 Guests are viewing this topic.

Offline agate

  • Administrator
  • *****
  • Posts: 7446
  • Location: Pacific Northwest
FDA says restricting MRI contrast agents "not warranted"
« on: May 24, 2017, 04:36:27 pm »
From NEJM Journal Watch, May 24, 2017:

Quote
FDA: Restricting MRI Contrast Agents "Not Warranted"

By Kristin J. Kelley

Edited by David G. Fairchild, MD, MPH, and Lorenzo Di Francesco, MD, FACP, FHM

There isn't evidence to warrant restricting the use of gadolinium-based contrast agents (GBCAs), the IV drugs used during magnetic resonance imaging, the FDA has concluded.

The agency began evaluating the risk for adverse health events associated with the heavy metal gadolinium retained in the brain after multiple uses of GBCAs. Reports showed that while gadolinium is retained in the body (including the brain, bones, and skin), no adverse health effects were found to be associated with the retention, apart from a rare condition known as nephrogenic systemic fibrosis.

The safety of GBCAs will continue to be investigated by conducting more research, including studies on how gadolinium is retained in the body. Clinicians should follow the FDA recommendations issued in 2015.

FDA safety alert, May 22, 2017


NEJM Journal Watch (July 28, 2015), "MRI contrast agents linked to brain deposits"









SPMS, diagnosed 1980. Avonex 2001-2004. Copaxone 2007-2010.

Offline agate

  • Administrator
  • *****
  • Posts: 7446
  • Location: Pacific Northwest
A followup to this, in MedPage Today, July 1, 2017, "Gadolinium builds, even in normal brains":

https://www.medpagetoday.com/Neurology/MultipleSclerosis/66343?xid=nl_mpt_DHE_2017-06-30&eun=g345846d0r&pos=1





SPMS, diagnosed 1980. Avonex 2001-2004. Copaxone 2007-2010.

Offline agate

  • Administrator
  • *****
  • Posts: 7446
  • Location: Pacific Northwest
--And then there is this, from Medical News Today, August 9, 2017:

Quote
MRI contrast agents accumulate in the brain


The International Society for Magnetic Resonance in Medicine (ISMRM) has provided new guidance in the use of contrast agents during MRI scans. Emerging research suggests gadolinium-based contrast agents, injected in a patient's veins to brighten tissues in MRI images, accumulate in the brain. More than 300 million doses of such drugs have been administered since their introduction in 1987.

"Small amounts of gadolinium deposit in certain parts of the brain in people who undergo repeated gadolinium-based contrast agent enhanced exams," said Vikas Gulani, MD, PhD, Associate Professor of Radiology, Urology, and Biomedical Engineering at Case Western Reserve University School of Medicine, member of the Case Comprehensive Cancer Center, and Director of Magnetic Resonance Imaging at University Hospitals Cleveland Medical Center. "The ISMRM response is a review of the literature and a series of recommendations on what the community ought to do in response to this phenomenon." Gulani helped craft the new recommendations and served as first author for the review, featured on the cover of The Lancet Neurology.

In the review, Gulani and other experts suggest if gadolinium is not needed for a particular exam, it should not be administered. A risk-benefit analysis should happen for all exams. "Nearly everyone needs an MRI scan at some point, often contrast enhanced," Gulani said. "The idea that some gadolinium could be depositing in the brain is disconcerting to patients. In that situation, putting the risk and benefits into context is important." If gadolinium is needed, it should be administered and the choice of agent is dependent on a large number of factors, only one of which is the deposition phenomenon.

Defining harm is an important consideration. Gadolinium-based contrast agents have a proven track record for accurate diagnosis and treatment monitoring of a large number of diseases including cancer, neurological pathology, heart disease, liver disease, and many other important conditions afflicting adults and children. They are associated with few side effects, the most serious of which are extremely infrequent and affect already sick patients with severe kidney failure. The new review does not suggest sweeping changes in the use of MRI contrast agents, as at present, there is no evidence linking the brain deposits to health risks. However, it provides clarity about the previously unknown phenomenon of gadolinium deposition in the brain and provides guidance for future research.


Article: MRI contrast agents accumulate in the brain: New clinical and research guidelines urge caution. Gulani, V., Calamente, F., Shellock, F. G., Kanal, E., Reeder, S. B. The Lancet, doi: 10.1016/S1474-4422(17)30158-8, published online July 2017.





SPMS, diagnosed 1980. Avonex 2001-2004. Copaxone 2007-2010.

Offline agate

  • Administrator
  • *****
  • Posts: 7446
  • Location: Pacific Northwest
FDA panel backs new warning for gadolinium contrast agents
« Reply #3 on: September 12, 2017, 03:17:36 pm »
An FDA advisory panel has voted to include a warning label on gadolinium contrast agents, with which persons with MS are undoubtedly familiar because they are used routinely with most MRIs.

From MedPage Today, September 11, 2017:

https://www.medpagetoday.com/Radiology/DiagnosticRadiology/67811?xid=nl_mpt_DHE_2017-09-12&eun=g345846d0r&pos=0





SPMS, diagnosed 1980. Avonex 2001-2004. Copaxone 2007-2010.

 

Related Topics

  Subject / Started by Replies Last post
2 Replies
51 Views
Last post March 17, 2017, 03:50:00 pm
by agate
0 Replies
9 Views
Last post December 09, 2016, 08:55:35 am
by agate
0 Replies
19 Views
Last post February 03, 2017, 01:26:23 pm
by agate
0 Replies
13 Views
Last post March 08, 2017, 02:47:14 pm
by agate
0 Replies
9 Views
Last post April 04, 2017, 03:06:55 pm
by agate