FDA Drug Safety Communication: FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warnings
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.
For more information go to https://www.fda.gov/Drugs/DrugSafety/ucm589213.htm