Gadolinium products are not FDA-approved for Breast MRI

I posted this in another breast cancer site forum.  I received a return telephone call from a Drug Information Officer with the FDA, confirming that none of the gadolinium products have FDA approval for breast MRI

The FDA considers this off-label use, "the practice of medicine."  She said, further, that the decision to use the gadolinium, or any other off-label product usage, resets with the Medical Boards.

The FDA will only take action about this off-label practice when it received sufficient complaints; in this case, from women who may have side effects from receiving the gadolinium product as part of a contrast breast MRI.  To me, that would include all the fouled, unreadable contrast breast MRIs.

There are no long-term studies concerning the use of gadolinium in women.

[healthcareguerilla]

I well understand that various drugs are used for off-label purposes.  I understand that, if it's a matter of life or death, we'll do what looks like it might work.  I do, however, believe that greater attention must be given to ensure that any drug we take, or equipment used in diagnosis, will be in our best interest, and that the FDA must take a stronger position in these matters.

[japdip]

This seems to be a subject that you should be discussing with someone associated with the FDA .... our Community here is strictly a pt. to pt. forum with questions/concerns and opinions or answers from those who have had similar experiences.

[healthcareguerilla]

I see.  My shock at my own, shall we call it, naivete, for believing that this contrast medium had FDA approval, and my thought that there may well be women who would like to know this, and might well want to contact legislators, etc., to request that the FDA weigh in on the use of it, is inappropriate?  There is strength in numbers.  A lone voice usually means little.

Well, before I am permanently banned from the site, let me throw in my 'surprise' that MRI is weighted quite low for the evaluation of nonpalpable breast masses; an issue here that is causing morning waking with the first thought - how much will the physicians involved pursue this before consensus is secured.  How much damange to body in psyche will there be before one can wake in the morning and not wonder where the expert radiologist is located that might clear this mess up in a few minutes.

http://www.dcamedical.com/webdocuments/appropriteness-criteria-non-palpable-breast-mass.pdf