On December 19, 2017, the FDA issued a new Safety Announcement related to gadolinium-based contrast agents (GBCAs) administered for MRIs. One of the actions described in the announcement was the requirement that every patient be given a Medication Guide to read before receiving a GBCA. The Medication Guides for all GBCAs are now available. However, on May 16, 2018, the FDA issued an Update to the requirement that patients be given the Medication Guides prior to their MRIs.
It appears that the FDA has determined that, “hospital inpatients are not required to receive a Medication Guide unless the patient or caregiver requests it”.
Since most people are not aware that patients are retaining gadolinium from GBCAs administered for MRIs or that gadolinium is a toxic metal, they will not know to ask for a copy of the Medication Guide or that one even exists. That will result in a vulnerable population of patients not being fully-informed about the potential risk of gadolinium deposition in their brain, bones, skin, and other tissues.
As documented in the medical literature, patients in hospitals are at greater risk of having an acute kidney injury or AKI which can impair patients’ kidney function and potentially cause them to retain more gadolinium. I believe that patients in hospitals and/or their families should be informed about that risk and they should be given a Medication Guide for the GBCA that will be administered for any inpatient imaging procedures.
The following is the FDA’s May 16, 2018 Update –
In addition to approving the updated prescribing information concerning the gadolinium retention safety issues described in the Drug Safety Communication below, FDA has also approved new patient Medication Guides for all GBCAs.
Health care professionals and patients can access the patient Medication Guides according to the GBCA drug name* on the Medication Guides webpage, or the latest prescribing information by searching in Drugs@FDA.
All MRI centers should provide a Medication Guide the first time an outpatient receives a GBCA injection or when the information is substantially changed. In general, hospital inpatients are not required to receive a Medication Guide unless the patient or caregiver requests it. A health care professional who determines that it is not in a patient’s best interest to receive a Medication Guide because of significant concerns about its effects may direct that it not be provided to that patient; however, the Medication Guide should be provided to any patient who requests the information.†
*The brand names of the GBCAs can be found in Table 1 below.
†For more information on distribution of Medication Guides, see the Guidance Document, the Drug Info Rounds Video, or the Code of Federal Regulations at 21 CFR 208.26.
The Update and original Safety Announcement can be found here – https://www.fda.gov/Drugs/DrugSafety/ucm589213.htm
The brand names of the gadolinium-based contrast agents currently in use in the U.S. are: Dotarem, Eovist, Gadavist, Magnevist, MultiHance, Omniscan, OptiMark, and ProHance.
If you have had an MRI with contrast and developed unexplained symptoms after it, please report it to MedWatch as soon as possible. You can access MedWatch Voluntary Reporting online here: https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home