News & Press: Patient Safety

FDA Warns Gadolinium-based Contrast Agents (GBCAs) Retained in the Body; Requires New Class Warnings

Thursday, May 17, 2018  
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SIS Patient Safety Alert 05/17/2018: FDA Drug Safety Communication: FDA Warns that Gadolinium-based Contrast Agents (GBCAs) are Retained in the Body; Requires New Class Warnings

This is an important alert from the Spine Intervention Society. SIS sends Patient Safety Alerts when it receives important information regarding products or services that can impact your patients' safety. When the Food and Drug Administration (FDA) issues a safety alert, or a company announces a recall or market withdrawal, the FDA posts the announcement as a public service. Neither SIS, nor the FDA endorse either the product or the company.

This is an update to the FDA Drug Safety Communication: FDA identifies no harmful effects to date with brain retention of gadolinium-based contrast agents for MRIs; review to continue issued on May 22, 2017.

In addition to approving the updated prescribing information concerning the gadolinium retention safety issues described in the Drug Safety Communication on May 22, 2017, 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.

Table 1. FDA-Approved GBCAs*

Brand name Generic name Chemical Structure
Dotarem gadoterate meglumine Macrocyclic
Eovist gadoxetate disodium Linear
Gadavist gadobutrol Macrocyclic
Magnevist gadopentetate dimeglumine Linear
MultiHance gadobenate dimeglumine Linear
Omniscan gadodiamide Linear
OptiMARK gadoversetamide Linear
ProHance gadoteridol Macrocyclic

*Linear GBCAs result in more gadolinium retention in the body than macrocyclic GBCAs.
Gadolinium levels remaining in the body are LOWEST and similar after use of these agents.
Gadolinium levels remaining in the body are HIGHEST after use of these agents.

Read the safety alert.

Source: U.S. Food and Drug Administration (FDA) (Accessed: 05/17/2018)

 


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