FDA approves new patient Medication Guides for all GBCAs

The FDA announced its approval of new patient Medication Guides for all gadolinium-based contrast agents (GBCAs) used for MRI, according to a May 16 press release.  

This is an update to approving prescribing information concerning GBCA retention safety described in the FDA's Drug Safety Communication issued in May 2017. 

"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," according to the FDA. 

Additionally, the FDA advises that healthcare providers who determine it's in the best interest of the patient to not receive a Medication Guide due to significant concerns about its effects is acceptable. However, any patient who requests the information should always receive it.

The new patient Medication Guides can be accessed through the FDA's Medication Guides webpage or by searching prescribing information at Drugs@FDA.