Study Warns Of Gadolinium Exposure Risks During Early Pregnancy

MRI scans on women early during pregnancy may be putting their unborn children at risk from gadolinium, which is used in MRI contrast dyes to help enhance images, and can cross the placenta, according to recent warnings by government researchers.

In a study published last week in the medical journal Radiology, researchers from the U.S. Food and Drug Administration (FDA) indicate that women injected with gadolinium-based contrast agents may unknowingly be in their first trimester of pregnancy, which could have negative health effects on the fetus.

Researchers looked at data on 4.7 million pregnancies that resulted in a live birth, indicating that there was one exposure to gadolinium-based contrast agents (GBCAs) per 860 pregnancies; or about 0.12%.

According to their findings, just over 70% of the gadolinium exposures during pregnancy occurred during the first trimester, suggesting that the healthcare professionals who conducted the MRI scans often did not know the women were pregnant.

“With regard to pregnancy, studies have shown that GBCAs pass through the placental barrier and enter the fetal circulation,” the researchers warned. “A recent study reported increased relative risk for stillbirth and neonatal death and increased risk of rheumatic, inflammatory, or infiltrative skin conditions in newborns after gadolinium exposure in utero. Food and Drug Administration–approved labeling was updated to state that GBCA administration should be considered during pregnancy only if the imaging is essential and cannot be delayed.”

Researchers urged healthcare professionals to perform pregnancy screening measures before using gadolinium contrast agents for MRIs on child-bearing aged women.

Gadolinium Contrast Agent Concerns

In December 2017, the FDA issued a drug safety communication for certain types of contrast agents, providing new information about the risk of gadolinium retention and potential side effects. As a result, manufacturers were required to provide new warnings and information in a Medication Guide, which all patients receiving an MRI contrast dye will be asked to read.

The FDA also recommended that health care professionals consider the fact that the body retains gadolinium when deciding whether to give it to patients that may be at higher risk of health problems. These include women who are pregnant or think they may be pregnant, patients with kidney problems, children, and patients when inflammatory conditions. The recommendations also suggest that repeated use of the contrast agents be minimized where possible, particularly when MRIs are scheduled closely together.

Patients are now urged to tell their health care professionals whether they are pregnant or may be pregnant, whether they have kidney problems, and the date of their last MRI with gadolinium, or whether they have had repeated MRI scans that involved the use of gadolinium contrast agents.

In recent years, there have also been growing concerns about the risk of gadolinium deposition disease, involving complaints of pain, brain fog and other symptoms experienced among individuals without kidney impairment, who have been found with an accumulation of the metal remaining in their body after an MRI exam.