Home » FDA
Category Archives: FDA
A petition drive to Stop the Damage and Find a Cure for Victims of MRI Contrast Toxicity has been started at change.org. The toxicity comes from the gadolinium that is retained from Gadolinium-Based Contrast Agents (GBCAs) administered for contrast-enhanced MRIs. We hope all of our readers will sign the petition and then tell all their friends who will sign it and then tell all of their friends. With today’s social media, we have a chance to get the attention of the FDA and other decision makers around the world.
The petition was started by MedInsight Research Institute. https://medinsight.org/ and specifically by Moshe Rogosnitzky, the co-founder and Executive Director. He is an established research scientist and medical innovator whose pioneering work has resulted in the development of new treatments for various types of cancer and auto-immune diseases. We have been in touch with Moshe since late 2015 when he first contacted us about gadolinium toxicity issues.
His blog post announcing the petition drive “What price will we pay for the FDA’s faith in Gd?” lays out his case for why various actions regarding the use of Gadolinium-Based Contrast Agents are needed now. He covers many of the points we have raised and brings new insight as to why the FDA, NIH, WHO, and other organizations worldwide must Stop the Damage and Find a Cure for Victims of MRI Contrast Toxicity, the headline for the petition.
Please take action now and show your support by signing this petition at Change.org.
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)
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