Details Basic Details Status Complete Last Updated Tuesday, December 19, 2017 Health Outcome(s) exposure in pregnancy Purpose Drug Use Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR No Regulatory Determination / Use Advisory Committee Presentation & FDA Drug Safety Communication Result(s) (1) Gadolinium-Based Contrast Agents (GBCAs) Use in Pregnancy Regulatory Link(s) (2) Medical Imaging Drugs Advisory Committee (MIDAC) Materials FDA Warns that Gadolinium-Based Contrast Agents (GBCAs) are Retained in the Body; Requires New Class Warnings Related Publication(s) and/or Presentation(s) (2) Publication: First-Trimester Exposure to Gadolinium-based Contrast Agents: A Utilization Study of 4.6 Million U.S. Pregnancies Presentation: First Trimester Exposure to Gadolinium Contrast; A Utilization Study of 4.6 Million Live-Birth Pregnancies