TabsDetailsBasic DetailsDate Posted: Thursday, April 4, 2019Status: CompleteMedical Product: gadolinium-based contrast agent (GBCA)Health Outcome(s): exposure in pregnancyDescription: Report 1: Gadolinium-Based Contrast Agents (GBCAs) Use in PregnancyRequest ID: cder_mpl1r_wp051This 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_wp020This 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. Read More Deliverables (2)Sentinel Modular Program Report: Gadolinium-Based Contrast Agents (GBCAs) Use in Pregnancy, Report 1Sentinel Modular Program Report: Gadolinium-Based Contrast Agents (GBCAs) Use in Pregnancy, Report 2Additional InformationAdditional DetailsFDA Center: CDERTime Period: 2006 – 2018Study Type: Modular ProgramAssessment Type: Safety AnalysesPopulation / Cohort: Females 10 years of age and olderData Sources: Sentinel Distributed Database (SDD)Related Links: 2018 ICPE Poster: First Trimester Exposure to Gadolinium Contrast; A Utilization Study of 4.6 Million Live-Birth PregnanciesFDA Drug Safety Communication: FDA Warns that Gadolinium-Based Contrast Agents (GBCAs) are Retained in the Body; Requires New Class WarningsMeeting of the Medical Imaging Drugs Advisory Committee: Gadolinium Retention Following Contrast MRI and Pregnancy UtilizationFDA Presentation at the Medical Imaging Advisory Committee: Gadolinium Retention Following Gadolinium-Based Contrast Agents MRIs: Brain and Other OrgansFirst-Trimester Exposure to Gadolinium-based Contrast Agents: A Utilization Study of 4.6 Million U.S. Pregnancies