What is the safety of Gadolinium (Gadolinium-based contrast agent) during pregnancy?

From the Guidelines

Gadolinium-based contrast agents should be avoided during pregnancy unless the potential benefits clearly outweigh the risks. These contrast agents, used in MRI scans, cross the placenta and enter the fetal circulation, as noted in the study by 1. While no definitive human studies have shown adverse effects on the developing fetus, animal studies have raised concerns about potential risks, such as those discussed in 1 and 1.

Key Considerations

• If imaging is absolutely necessary during pregnancy, non-contrast MRI is preferred when possible.
• In situations where contrast is deemed essential, macrocyclic gadolinium agents (such as gadoterate meglumine, gadobutrol, or gadoteridol) are considered relatively safer choices than linear agents due to their greater stability and lower risk of gadolinium retention, as suggested by the principles outlined in 1.
• The decision to use gadolinium during pregnancy should be made on a case-by-case basis through careful consultation between the patient, obstetrician, and radiologist, emphasizing the importance of informed consent and risk assessment, as recommended in 1.
• The timing of the pregnancy may also factor into the risk assessment, with some experts suggesting slightly lower theoretical risk in the second or third trimesters compared to the first trimester when organogenesis occurs.
• After gadolinium administration, breastfeeding can typically continue as minimal amounts transfer into breast milk.

Evidence Summary

The studies 1, 1, and 1 provide insights into the use of gadolinium-based contrast agents during pregnancy, highlighting the need for caution and careful consideration of the potential benefits and risks. The most recent and highest quality study, 1, published in 2024, emphasizes the importance of using contrast agents only when necessary and with careful consideration of the potential risks to the fetus.

Clinical Implications

In clinical practice, the use of gadolinium-based contrast agents during pregnancy should be approached with caution, and alternative imaging methods should be considered when possible. The decision to use these agents should be made on a case-by-case basis, taking into account the specific clinical circumstances and the potential risks and benefits, as outlined in the principles discussed in 1.

From the FDA Drug Label

8.1 Pregnancy Risk Summary GBCAs cross the placenta and result in fetal exposure and gadolinium retention. The human data on the association between GBCAs and adverse fetal outcomes are limited and inconclusive Because of the potential risks of gadolinium to the fetus, use Gadoteridol Injection only if imaging is essential during pregnancy and cannot be delayed

The use of gadolinium during pregnancy should be avoided unless imaging is essential and cannot be delayed, due to the potential risks of gadolinium retention in the fetus.

• Key points:
  • Gadolinium crosses the placenta and results in fetal exposure
  • Human data on the association between GBCAs and adverse fetal outcomes are limited and inconclusive
  • Use Gadoteridol Injection only if imaging is essential during pregnancy and cannot be delayed 2

From the Research

Gadolinium Safety in Pregnancy

• The use of gadolinium-based contrast agents (GBCAs) during pregnancy is a topic of concern, with some studies suggesting potential risks 3, 4.
• According to a 2008 study, intravenous gadolinium is contraindicated in pregnancy and should only be used when absolutely essential 3.
• A 2020 study found that GBCA administration may be associated with a slightly higher rate of neonatal death, although this is based on a single, large cohort study 4.
• Another study from 2007 reported that there are no known negative effects on the fetus from the application of gadolinium-containing contrast media to pregnant mothers 5.

Risks and Benefits of Gadolinium-Based Contrast Agents

• The responsible use of GBCAs requires a balance between safety and clinical utility, with benefits including the prevention of morbidity or death 6.
• A 2020 review of the risks and benefits of GBCA administration found that while there are potential risks, such as nephrogenic systemic fibrosis (NSF) and gadolinium deposition, the likelihood of developing NSF is negligible with macrocyclic agents 6.
• A 2024 update on GBCA safety found that acute allergic-like reactions, NSF, gadolinium deposition, and symptoms associated with gadolinium exposure are distinct safety considerations, but that GBCAs are generally safe 7.

Use of Gadolinium-Based Contrast Agents in Pregnancy

• The American College of Radiology and other regulatory agencies suggest that no screening is necessary when macrocyclic GBCAs are used, as the likelihood of developing NSF is negligible 6, 7.
• However, it is recommended that the use of GBCAs during pregnancy be carefully considered and discussed with patients, weighing the potential risks and benefits 3, 4.