FDA Warning concerning Gadolinium-Enhancing Contrast Agents

[Ga dancer]

This article came to my email box today, and it is of great concern to MS patients who have serial MRI's to track progress of our disease. My last MRI indicated brain volume loss advanced for age, although certainly no surprise to me as I struggle with memory issues.

The article can be accessed here: http://www.medpagetoday.com/Radiolog...eun=g530971d0r

[share0919]

Gadolinium deposition in the brain

Following the 07/27/15 FDA alert:
http://www.fda.gov/Safety/MedWatch/S...ce=govdelivery

I found these two papers that explain the issue in more detail:
http://pubs.rsna.org/doi/full/10.1148/radiol.15150025
and
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4498420/

Has anybody discussed this issue with his/her neurologist and/or radiologist? Are they concerned about the frequency of MRIs?

[steve19]

I've had gadolinium 6 times. I rejected it yesterday, with my latest MRI. I want to see what the FDA investigation yields.

[jreagan70]

It's important to note that the issue of this safety alert isn't the frequency of MRIs, it's the frequency of using gadolinium contrast. The safety of MRIs per se (meaning the safety of MRIs done without contrast) isn't the subject of this alert.

Some neuros are just slap-happy about ordering MRIs with contrast every 6 months whether there's an indication for it or not. This safety alert encourages them to stop that.

There's a role for contrast, particularly during the diagnostic process, when it can help to quickly establish dissemination of lesions in time.

The diagnostic MRI is probably the first time that most people with MS ever have gadolinium, so it isn't building on previous exposure. In diagnosing a condition as serious as MS, the risks of gadolinium build-up are less important than the risk to kidney function, and that's already small in otherwise healthy patients. (I have decreased kidney function and I've never had a problem clearing gadolinium.)

Contrast can also be helpful in investigating a flare, which is why it's used. This alert may slow neuros in automatically ordering contrast as a routine practice. If an MRI done without contrast can establish the presence of a new lesion that explains the new symptom(s), contrast might not be necessary. Contrast isn't needed to find lesions; they'll show up without contrast.

What might happen as a result of this alert is that it will become standard practice for MRIs in MS flares or progress checks to be ordered without contrast and then another MRI done with contrast in a separate session only if indicated. Splitting the MRIs into 2 sessions will be inconvenient, but the trade-off is to avoid a possible health hazard.

The FDA safety alert was issued only this week, so the only people/patients who would have had a chance to talk to their neurologists about it would be those who have, coincidentally, seen their doctors or had an MRI in the last 2 or 3 days.

Although news stories are calling this a warning, the FDA -- which issued the alert -- didn't call it a warning because the implications of the gadolinium buildup aren't even known yet.

[Jules A]

It's important to note that the issue of this safety alert isn't the frequency of MRIs, it's the frequency of using gadolinium contrast. The safety of MRIs per se (meaning the safety of MRIs done without contrast) isn't the subject of this alert.

Some neuros are just slap-happy about ordering MRIs with contrast every 6 months whether there's an indication for it or not. This safety alert encourages them to stop that.

There's a role for contrast, particularly during the diagnostic process, when it can help to quickly establish dissemination of lesions in time.

The diagnostic MRI is probably the first time that most people with MS ever have gadolinium, so it isn't building on previous exposure. In diagnosing a condition as serious as MS, the risks of gadolinium build-up are less important than the risk to kidney function, and that's already small in otherwise healthy patients. (I have decreased kidney function and I've never had a problem clearing gadolinium.)

Contrast can also be helpful in investigating a flare, which is why it's used. This alert may slow neuros in automatically ordering contrast as a routine practice. If an MRI done without contrast can establish the presence of a new lesion that explains the new symptom(s), contrast might not be necessary. Contrast isn't needed to find lesions; they'll show up without contrast.

What might happen as a result of this alert is that it will become standard practice for MRIs in MS flares or progress checks to be ordered without contrast and then another MRI done with contrast in a separate session only if indicated. Splitting the MRIs into 2 sessions will be inconvenient, but the trade-off is to avoid a possible health hazard.

The FDA safety alert was issued only this week, so the only people/patients who would have had a chance to talk to their neurologists about it would be those who have, coincidentally, seen their doctors or had an MRI in the last 2 or 3 days.

Although news stories are calling this a warning, the FDA -- which issued the alert -- didn't call it a warning because the implications of the gadolinium buildup aren't even known yet.

Thanks for adding this. I'm not letting it get me all jazzed up just yet. I have MRIs with contrast every 14 months. For crap sake I have MS does it really matter if I have some contrast buildup in my brain? I'm thinking probably not.

[jreagan70]

For crap sake I have MS does it really matter if I have some contrast buildup in my brain? I'm thinking probably not.

And I'm thinking that I agree with you.

It's just the cost of doing business.

[Thinkimjob]

Now, me with my coiled aneurysm and MS (yes no poor, poor pitiful me), I was slightly aghast that my last MRI for MS did not include the "dye" for the aneurysm.

I was a tad off my guts on Valium at the time, so I couldn't protest except in a rather feeble fashion. After which I went back to sleep.

I loathe MRIs. Much prefer angiograms. At least you get a cup of tea and a sandwich.

[JerryD]

'First, do no harm' ! Many times doctors must consider the risk to benefit ratio in their decisions ! These people are doctors not gods. That is the reason I spent 6 years trying to find (and found) an MS 'specialist' in my locality .

[rdmc]

Thanks for the links.

I was going to reject gad next go anyway, but this adds fuel to the fire that is "no more gad for me." (my neuro does MRI once a year with contrast)

My MRI was last April, and they ordered it with gadolinium. I had had a mild reaction to the contrast agent when I had a dye study of my pump, a month before, and I made sure the neuro knew that, but they argued that gad and the agent they used for the pump study were different. Okay, so I had the contrast.

I developed hives. They were really pronounced on the gad injection arm...but also on my other arm and eventually spread. After they didn't clear up in a week (I took benadryl that week), I went to my dermatologist. She did a skin biopsy, and sure enough it was urticaria, there had been some question because they weren't acting like standard hives, they didn't itch but were prickly and burning like a nerve pain, and they didn't fade in and out.

Long story, short...I have what the dermatologist is calling "chronic hives." The thinking is something gets them started, and then they develop a life of their own...i.e. the initial reaction was to a med, but now my immune system is confused and is producing too much histamine,
resulting in hives. Three different antihistamines a day are keeping them somewhat controlled, but it doesn't look like they're going away anytime soon.

So I'm in the "no gad for me" club from now on.

P.S. In my reading about gad and hives, I came across info that people with kidney problems should be careful with gad...it can produce a severe skin problem, if there is renal insufficiency...they used to say just severe renal problems, now they say moderate, can develop this condition after gad. It's Nephronic Systemic Fibrosis (NSF), and it sounds awful, plus there's no treatment or cure. Has anyone been asked about your kidney function before they give you gad...I'd be betting "no." Here's a link to that info:

http://www.fda.gov/Drugs/DrugSafety/.../ucm142889.htm

[rdmc]

my mistake...if you read the article I posted on gad and NSF...it was considered a risk if you had moderate renal insufficiency,and now they've changed their warning and taken moderate out of the equation, just left in severe.

[Jules A]

And I'm thinking that I agree with you.

It's just the cost of doing business.

MS has marked raised the threshold on my concern about developing earth shattering conditions. Heart attack? meh
Cancer? whatever
Plane crash? bring it on

At this point my rationale is anything that might take me quicker than MS has the potential to isn't necessarily a bad thing.

[KatieAgain]

MS has marked raised the threshold on my concern about developing earth shattering conditions. Heart attack? meh
Cancer? whatever
Plane crash? bring it on

At this point my rationale is anything that might take me quicker than MS has the potential to isn't necessarily a bad thing.

I unfortunately am of the same opinion. But I wish I wasn't...