A study conducted by a team of scientists from the University of Nebraska Medical Center (UNMC), published in the scientific journal Molecular Psychiatry, has revealed a significant link between the use of cholesterol synthesis inhibitor medications during pregnancy and the risk of developing Autism Spectrum Disorder (ASD) in children.
As part of the study, researchers classified medications not by their primary indications, but by their impact on sterol biosynthesis and shared side effects. Sterol Biosynthesis Inhibitor Medications (SBIMs) include certain antidepressants, antipsychotics, anxiolytics, beta-blockers, and statins.
The study detailed 15 specific drugs: aripiprazole, atorvastatin, bupropion, buspirone, fluoxetine, haloperidol, metoprolol, nebivolol, pravastatin, propranolol, rosuvastatin, sertraline, simvastatin, cariprazine, and trazodone. Notably, many of these are among the most frequently prescribed medications in the United States. Using the Epic Cosmos medical database as empirical material, researchers analyzed the health records of 6,135,213 mother-child pairs, representing nearly one-third of all children born in the U.S. between 2014 and 2023.
This is the first large-scale national study to evaluate fetal neurodevelopmental outcomes following prenatal exposure to medications affecting the cholesterol synthesis pathway.
Key Findings:
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Risk Factor: Mothers prescribed at least one SBIM during pregnancy were 1.47 times more likely to have a child with ASD.
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Dose-Response Relationship: The risk increased 1.33 times with each additional co-prescribed SBIM. When using four or more SBIMs simultaneously, the risk was 2.33 times higher than the baseline.
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Scale of Exposure: Out of 234,971 children diagnosed with ASD in the study cohort, 15% had prenatal exposure to the SBIM group of medications.
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Growth Dynamics: The rate of SBIM use during pregnancy rose sharply, from 4.6% in 2014 to 16.8% in 2023.
The Importance of Sterol Biosynthesis
Cholesterol is vital for fetal development, particularly for the brain, which is the most cholesterol-rich organ. The fetal brain begins producing its own sterols around the 19th–20th week of gestation. Genetic disruptions of this biochemical pathway lead to severe pathologies, including Smith-Lemli-Opitz Syndrome (SLOS), in which up to 75% of children meet the diagnostic criteria for Autism Spectrum Disorder.
“Our findings do not imply that these medications are dangerous for adults. However, they raise questions about their use during pregnancy, as even minor biochemical changes during this period can have a critical impact on fetal brain formation,” said study co-author Karoly Mirnics, M.D., Ph.D.
Scientists emphasize that patients should not discontinue treatment on their own, as these medications are often life-saving. Instead, the study calls on healthcare professionals to review prenatal prescribing practices and develop safer alternatives.
Future Perspectives
The research team prioritizes the systemic improvement of medication safety for pregnant women, including:
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Creating a comprehensive and updated registry of Sterol Biosynthesis Inhibitor Medications (SBIMs).
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Mandatory evaluation of new pharmaceutical products for their potential impact on sterol biosynthesis.
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Raising awareness among medical personnel to avoid risky drug combinations during prescription.
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Timely identification of genetically vulnerable patients.
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Conducting in-depth research to establish precise biochemical mechanisms and minimize the negative risks of medication impact on fetal development.
