As coauthors of The Lighthouse Project, we have 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 in advance of its September 8, 2017 meeting. We will be making a brief oral presentation during the Open Public Hearing portion of the meeting which will be held at the FDA’s White Oak Campus in Silver Spring, Maryland.
Our comments are built around the following 6 major points that we cover in making the case that the FDA needs to take action regarding the use of Gadolinium-based Contrast Agents (GBCAs) administered for contrast-enhanced MRIs.
1. Medical literature documents toxicity of gadolinium and systemic implications.
2. The Risk Factors for adverse results are many.
3. NSF-Like Symptoms in patients with normal renal function.
4. Gadolinium from GBCAs does not clear the body in a few days, or even in a few months, allowing plenty of time for the Gd ion to dissociate from the chelate.
5. Underreported Symptoms from Contrast MRIs is a serious problem.
6. There is evidence of clinical implications of gadolinium deposition.
Our detailed comments can be found here: Comments-from-Lighthouse-Project-FDA-2017-N-1957 . We also included the following supporting materials:
- Sharon’s 2012 Letter to the FDA (SWilliams-2012FDALetter-FDA-2017-N-1957)
- Our Symptom Survey of the Chronic Effects of Retained Gadolinium from Contrast MRIs (Lighthouse Symptom Survey copy for Docket FDA-2017-N-1957), and
- Our most recent report, Gadolinium Retention from Contrast MRIs in 70 Cases with Normal Renal Function – 24-hour Urine Test Results (Lighthouse 70 Case Retention Study copy for Docket FDA-2017-N-1957)
We will report back later about our experience at the FDA Advisory Committee Meeting.
Sharon Williams and Hubbs Grimm