Gadolinium-Based Contrast Agents (GBCAs) Use in Pregnancy

Project Title Gadolinium-Based Contrast Agents (GBCAs) Use in Pregnancy
Date Posted
Tuesday, December 19, 2017
Project ID
cder_mpl1r_wp051
Status
Complete
Deliverables
Related Links
Description

The Division of Medical Imaging Products (DMIP) has held an Advisory Committee meeting to discuss the risk of brain deposits with repeated use of gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI) and to characterize the population using GBCAs. Data from the Sentinel drug use request will help to characterize the use of GBCAs in pregnancy for the DMIP Advisory Committee meeting.

Medical Product
gadolinium-based contrast agent (GBCA)
Health Outcome
exposure in pregnancy
Population / Cohort
All females 10 years of age or older
Time Period
January 1, 2006 – September 30, 2015
Assessment Type
Safety Analyses
Study Type
Modular Program
Data Sources
Sentinel Distributed Database (SDD)
FDA Center
CDER