Karoly Mirnics<\/strong><\/strong><\/p>\n<\/div>\nMirnics and colleagues used data from March 2025 to January 2026 from the Epic Cosmos database, which includes more than 300 million patient records from 1,880 hospitals and 42,400 clinics. <\/p>\n
The study included 6,135,213 children (52% boys; 54% white) with linked maternal health records who were born between 2014 and 2023 and had at least one health care follow-up at age 18 months or later. Mothers had a prescription of one of 15 sterol biosynthesis inhibiting medications (SBIM), including aripiprazole, atorvastatin, bupropion, buspirone, fluoxetine, haloperidol, metoprolol, nebivolol, pravastatin, propranolol, rosuvastatin, sertraline, simvastatin and\/or trazodone during pregnancy. <\/p>\n
The researchers used Cox proportional hazard modeling to determine a link between ASD diagnosis in offspring and use of maternal SBIM, with the primary outcome <\/b>a diagnosis of ASD, defined as any of 51 diagnostic codes relating to the disorder.<\/p>\n
The study demonstrated a 1.47-fold (95% CI, 1.45-1.49) increased risk for an ASD diagnosis when mothers were exposed to at least one SBIM when pregnant. This risk increased 1.33 times (95% CI, 1.32-1.34) for each additional SBIM prescribed, with a maximum 2.33-fold (95% CI, 2.09-2.6) risk with four or more different SBIM prescriptions. <\/p>\n
A total of 3.8% of children (n = 234,971) were diagnosed with ASD in the 10 years of the cohort. Of these children, 15% of their mothers (n = 35,152) were prescribed one or more SBIM while pregnant. <\/p>\n
Mirnics told Healio the increase in SBIM utilization among pregnant women was significant, more than tripling over the decade of the study (2014, 4.6% vs. 2023, 16.8%). <\/p>\n
He further advised clinicians to review pregnancy warnings that are disclosed in prescriber information leaflets, but \u201cusually deeply buried in these leaflets.\u201d <\/p>\n
\u201cAlso, be aware that different medications are prescribed by different specialties (eg, psychiatrists vs. cardiologists) to the same patients, and the effects of polypharmacy on the developing baby brain are rarely known,\u201d Mirnics said. <\/p>\n
\u201cFinally, if a woman plans to become pregnant, have a frank discussion about potentially unwanted medication side effects on the baby vs. the benefits to her own health so they can make an informed decision.\u201d <\/p>\n
Mirnics also highlighted that while the study shows a link between prenatal SBIM use and an ASD diagnosis in offspring, it does not mean all women taking these medications will have a child with ASD. Further, \u201cmany women not taking SBIM will have a child with autism,\u201d he said. <\/p>\n
\u201cWe believe that the most impacted population would be when both the mother and the developing fetus have a genetic vulnerability in a sterol biosynthesis gene, and they are prescribed one or more SBIMs during pregnancy,\u201d Mirnics told Healio. \u201cThis is a hypothesis right now, and this should be proven in follow-up studies.\u201d<\/p>\n
For more information:<\/h2>\n Karoly Mirnics, MD, PhD<\/b>, <\/b>can be reached via the University of Nebraska Medical Center PR office at <\/b> john.keenan@unmc.edu.<\/p>\n\n
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Perspective<\/h2>\n Back to Top
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Autism is caused by a complex interplay of genetic and environmental factors, and it is unlikely to be caused by any single exposure. While this study suggests an association between SBIM use during pregnancy and autism, it does not provide evidence of causation. Many of the medications studied are prescribed for underlying conditions that also may be linked to increased autism risk, making it difficult to fully understand what\u2019s driving the findings. We recommend that individuals speak with their health care provider before making any changes to prescribed medications during pregnancy.<\/default:p><\/p>\n\n
Andy Shih, PhD<\/strong><\/p>\nChief Science Officer, Autism Speaks<\/p>\n
Disclosures: <\/strong> Healio could not confirm relevant financial disclosures at the time of publication.
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