Based on our own experiences and those of the other affected patients we know, it is clear to us that Gadolinium retention from Gadolinium-based Contrast Agents is not just a problem for patients with severe kidney disease. Unfortunately, because of what physicians have been told about NSF and Gadolinium retention, most doctors won’t consider the possibility that patients with normal renal function (meaning eGFRs >60) could be adversely affected by GBCAs, which in turn means that no one is being told about this potential evidence of a more widespread problem related to the use of Gadolinium-based Contrast Agents.
We do not believe that every patient exposed to GBCAs will get full-blown NSF as seen in the severely renally-impaired; however, since Gadolinium is toxic, any amount retained has the potential to cause internal damage. The severity of each patient’s symptoms likely depends on the total amount of Gadolinium that he or she retained from the administered contrast agent. We believe that Gadolinium Toxicity is a “disease of degrees”, all of which are potentially serious and life-changing. NSF may be the most severe manifestation of Gadolinium Toxicity, but based on findings in the published literature, there is no logical reason to think that it is the only one.
While Gadolinium Toxicity does directly affect us, our overriding motivation is to provide a voice for those who it seems are currently left to fend for themselves in their search for both answers and appropriate medical care. Because of the scope of the problem, we realized that it would take a concerted effort to bring the facts about Gadolinium retention and the symptoms of Gadolinium Toxicity to light.
Since 2012 when we first contacted the FDA about our concerns, we have been devoted to finding ways to have Gadolinium Toxicity recognized as a serious medical condition that can potentially happen to any patient who receives a Gadolinium-based Contrast Agent for an MRI or MRA.
We are not alone in our advocacy efforts. Without the participation of other affected patients, our research papers would not have been possible. But we still have work to do, and we are committed to seeing it through to the end.
In 2012, after more than a year researching the topic, Sharon Williams, one of the co-authors of this site, wrote a detailed Letter to the FDA about the issue of Gadolinium Retention. We are quite disappointed that four years later, nothing substantive has been achieved. We suggest you read the Letter including an introduction to see how clear this problem has been since before 2012.
In 2017 we provided written comments about the toxic effects of gadolinium and gadolinium retention in patients with normal renal function to the FDA’s Medical Imaging Drugs Advisory Committee and presented the material at the September 8, 2017 meeting. At that meeting , the FDA Committee voted to “revise the prescribing information for GBCAs as a class to include: a warning for retention for all GBCAs, with greater retention of all or some of the linear GBCAs compared to the macrocyclics in certain organs including the brain; recommended risk minimization steps for certain patient populations”. See our coverage of the meeting including links to videos of the presentations and voting for more information. The revised prescribing information including the warning that must be provided to patients receiving a contrast-enhanced MRI are now in use.
Our efforts are presently focused in three areas:
- This website for getting the word out to everyone
- Conducting and publishing our own research papers
- Providing our research papers and other relevant information to the FDA and other influential medical professionals
We want to stress the value we see in the last point. By reaching out to researchers and people in the MRI safety community, we have had some success in developing relationships in which the medical person trusts us and supports our efforts. Because the “system” works so slowly, we will continue to reach out to these people to create a critical mass of support that will start the reaction to recognize Gadolinium Toxicity as a medical condition.
One of the most important things you can do is to report your unexplained symptoms that you believe were caused by retained Gadolinium from a contrast MRI or MRA. You can report it to the FDA by filing a MedWatch Adverse Event Report.
You can also help by passing our research papers on to your family, friends and health care providers. We have been surprised by the reactions to our research from our own doctors. Most believe that the MRI contrast agent will be gone from the body within a few days after the contrast MRI, and they are surprised by the Gadolinium retention we have documented in patients with normal kidney function.
When sharing our papers, please note the Copyright information at the bottom of the front page of each research paper. Thank you for your efforts to get the word out about Gadolinium Toxicity. Working together, we can make a difference.