First-Trimester Exposure to Gadolinium-based Contrast Agents: A Utilization Study of 4.6 Million U.S. Pregnancies

Project Title First-Trimester Exposure to Gadolinium-based Contrast Agents: A Utilization Study of 4.6 Million U.S. Pregnancies
Date
Tuesday, August 20, 2019
Location
Description

The safety of gadolinium-based contrast agent (GBCA) exposure during pregnancy has not been established, and the use of GBCAs during pregnancy is not recommended unless it is essential to the health of the woman or fetus. The Sentinel Distributed Database was used to retrospectively identify U.S. pregnancies that resulted in live births between 2006 and 2017 from 16 data partners. The main outcome was the prevalence of MRI procedures with and without GBCAs, sorted by anatomic location and trimester, among pregnant and matched comparator women.

This study identified higher rates of GBCA exposure during the first few weeks of pregnancy compared with the later weeks of pregnancy, suggesting inadvertent exposure to GBCAs might occur before pregnancy is recognized.

Corresponding Author

Steven T. Bird, Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmacovigilance and Epidemiology, Division of Epidemiology
Email: steven.bird@fda.hhs.gov

Authors

Steven T. Bird, Kate Gelperin, Leyla Sahin, Karen B. Bleich, Elnara Fazio-Eynullayeva, Corinne Woods, Erica Radden, Patty Greene, Carolyn McCloskey, Tamara Johnson, Mayura Shinde, Ira Krefting

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