Gadolinium-Based Contrast Agents (GBCAs) Use in Pregnancy

Project Title Gadolinium-Based Contrast Agents (GBCAs) Use in Pregnancy
Date Posted
Thursday, April 4, 2019
Project ID
cder_mpl1r_wp051, cder_mpl1p_wp020
Status
Complete
Deliverables
Sentinel Modular Program Report: Gadolinium-Based Contrast Agents (GBCAs) Use in Pregnancy, Report 1
Sentinel Modular Program Report: Gadolinium-Based Contrast Agents (GBCAs) Use in Pregnancy, Report 2
Related Links
2018 ICPE Poster: First Trimester Exposure to Gadolinium Contrast; A Utilization Study of 4.6 Million Live-Birth Pregnancies
FDA Drug Safety Communication: FDA Warns that Gadolinium-Based Contrast Agents (GBCAs) are Retained in the Body; Requires New Class Warnings
Meeting of the Medical Imaging Drugs Advisory Committee: Gadolinium Retention Following Contrast MRI and Pregnancy Utilization
FDA Presentation at the Medical Imaging Advisory Committee: Gadolinium Retention Following Gadolinium-Based Contrast Agents MRIs: Brain and Other Organs
First-Trimester Exposure to Gadolinium-based Contrast Agents: A Utilization Study of 4.6 Million U.S. Pregnancies
Description

Report 1: Gadolinium-Based Contrast Agents (GBCAs) Use in Pregnancy
Request ID: cder_mpl1r_wp051

This report characterizes the use of GBCAs in pregnancy in the Sentinel Distributed Database (SDD). Data from January 1, 2006 to September 30, 2015 from 16 Data Partners contributing to the SDD were included in this report. This request was distributed to Data Partners on June 13, 2017.
These results were presented at the Division of Medical Imaging Products (DMIP) Advisory Committee meeting to discuss the risk of brain deposits with repeated use of GBCAs for magnetic resonance imaging (MRI) and to characterize the population using GBCAs. View more information here.

Report 2: Gadolinium-Based Contrast Agents (GBCAs) Use in Pregnancy (an update to cder_mplr_wp051)
Request ID: cder_mpl1p_wp020

This report contains estimates of magnetic resonance imaging (MRI) procedure utilization, with and without GBCAs, before and during pregnancies resulting in a live-born delivery among women of reproductive age in the SDD. Data from January 1, 2006 to January 31, 2018 from 16 Data Partners contributing to the SDD were included in this report. This request was distributed to Data Partners on June 28, 2018.

Medical Product
gadolinium-based contrast agent (GBCA)
Health Outcome
exposure in pregnancy
Population / Cohort
Females 10 years of age and older
Time Period
2006 – 2018
Assessment Type
Safety Analyses
Study Type
Modular Program
Data Sources
Sentinel Distributed Database (SDD)
FDA Center
CDER
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