Review calls attention to brain development risks associated with certain medications during pregnancy

by University of Nebraska-Lincoln

edited by Sadie Harley, reviewed by Robert Egan

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A review article by a University of Nebraska Medical Center/Child Health Research Institute research team underscores how altering fundamental brain development processes can harm the developing fetus. The publication suggests that curtailing the use of certain medications could reduce the risk of neurodevelopmental pathology in the developing fetal brain. The medications studied include some statins, antidepressants, anxiety medications and cardiovascular drugs.

Cholesterol biosynthesis is essential for proper brain development. When it is disrupted, the article states, children may be born with or develop complex neurodevelopmental disorders, such as autism, fetal fentanyl syndrome and Smith-Lemli-Opitz syndrome.

The Journal of Clinical Investigation article contextualizes previous publications by members of the same team and their national and international collaborators, including more than 125 other well-respected, peer-reviewed publications.

Prescription use rose sharply

UNMC and CHRI's Karoly Mirnics, MD, Ph.D., corresponding author of the article and dean and director of the Munroe-Meyer Institute, said the impact of interfering with the prenatal sterol biosynthesis pathway using sterol biosynthesis-inhibiting medications (SBIMs) is well documented.

"In addition, our recently published study of 6.14 million health records from mothers and their children across the United States—about one out of every three births between 2014 and 2023—shows that among women who were prescribed these medications, there was a significantly increased incidence of autism spectrum disorder (ASD) in their children," he said.

"A particular concern is that utilization of these medications by pregnant women is on a steep rise, more than tripling over the decade from 2014 to 2024," said UNMC and CHRI's Eric Peeples, MD, Ph.D., associate professor in the UNMC Division of Neonatology and lead author of both the new review of scientific literature and that earlier publication.

The April Molecular Psychiatry study found that use of these medications during pregnancy increased from 4.6% of pregnancies in 2014 to 16.8% of pregnancies in 2023. Notably, the 15 studied medications were among the most commonly prescribed drugs in the U.S., with more than 400 million prescriptions a year.

Warnings may be easy to miss

Mirnics and co-author Zeljka Korade, DVM, Ph.D., professor in the UNMC Division of Pediatric Inherited Metabolic Diseases, were among the researchers who first identified the mechanism underlying fetal fentanyl syndrome (FFS), also through inhibition of the same biological system: sterol biosynthesis in the developing brain.

Concern that SBIMs used during pregnancy could lead to adverse outcomes "is not new," as the authors state in their paper.

"Medication package inserts (FDA-approved prescription information) developed by pharmaceutical companies clearly state the risks of medications if taken during pregnancy," the article states. "Unfortunately, although the package inserts are easily accessible for physicians and patients, the relevant data are often buried in the large amount of information in them."

Mirnics and his co-authors also point to the 2015 "retirement" of the FDA's A, B, C, D and X pregnancy medication risk categories in favor of "narrative sections and subsections." In their view, while this new approach provides more nuanced information, it can cause confusion and could be counterproductive for health care workers who prescribe medications and for patients.

Questions extend beyond birth

Mirnics suggests the studies his team reviewed may be only the tip of the iceberg.

"Apart from the more apparent dysmorphologies and dysfunctions, we are left with the question of whether inhibiting fetal sterol biosynthesis can result in other developmentally rooted challenges, such as anxiety, OCD and ADHD, that do not appear until much later in life.

"More research is clearly needed, but these grave concerns should not be ignored," he said.

Publication details

Eric S. Peeples et al, Sterol biosynthesis, brain development, and disease, Journal of Clinical Investigation (2026). DOI: 10.1172/jci208000

Journal information: Journal of Clinical Investigation , Molecular Psychiatry

Key medical concepts

cholesterol biosynthesisAutism Spectrum DisorderSmith-Lemli-Opitz syndrome

Clinical categories

NeurologyPregnancyClinical pharmacologyObstetrics & gynecologyPediatricsCommon illnesses & Prevention Provided by University of Nebraska-Lincoln Who's behind this story?

Sadie Harley

BSc Life Sciences & Ecology. Microbiology lab background with pharmaceutical news experience in oil, gas, and renewable industries. Full profile →

Robert Egan

Bachelor's in mathematical biology, Master's in creative writing. Well-traveled with unique perspectives on science and language. Full profile →

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