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The Mt. Sinai review linking prenatal acetaminophen use to neurodevelopmental disorders (NDDs) has several key limitations, primarily that it establishes an association, not a causal link. The study, a meta-analysis of existing research, acknowledges that its findings underscore the need for further study and that confounding factors cannot be ruled out.
The study’s primary limitations
Despite these limitations, the Mt. Sinai review and other similar research suggest that caution may be warranted, particularly for heavy or prolonged use of acetaminophen during pregnancy. For this reason, groups like the FDA and the study's authors now recommend a "judicious" approach: use the lowest effective dose for the shortest possible duration under a doctor's guidance.
It is crucial to remember that untreated high fever during pregnancy can also harm a fetus. Therefore, pregnant women should always consult their doctor for personalized advice before making any changes to medication.
The study’s primary limitations
- Correlation does not equal causation. The review, published in BMC Environmental Health in August 2025 by researchers from the Icahn School of Medicine at Mount Sinai and Harvard, analyzed 46 previous studies. The authors themselves stated that the review found an association between prenatal acetaminophen exposure and NDDs like autism and ADHD, but not a causal link.
- Confounding variables.One of the most significant challenges is separating the effect of acetaminophen from the underlying health conditions it is used to treat. For example, the fever or infection that prompted a woman to take acetaminophen could be the actual cause of the adverse neurodevelopmental outcome, not the medication itself.
- Sibling studies. The potential for confounding by indication is highlighted by research like a large 2024 Swedish study, which found no link between acetaminophen and NDDs in sibling control analyses. This suggests that associations seen in other studies may be due to shared genetic or environmental factors within families, not the drug.
- Methodological weaknesses in source studies. Many of the studies reviewed relied on participants' self-reporting of their medication use, which can lead to inaccuracies and recall bias. The August 2025 review's authors noted that relying on maternal self-reports could lead to an underestimation of the true effects.
- Limited biomarker data. Some higher-quality studies have used biomarkers to measure exposure. However, one expert cited in explained that biomarkers found at birth only reflect use late in pregnancy, not during earlier neurodevelopmentally relevant periods.
- Contradictory evidence. The findings are not universally accepted and conflict with other research. For example, studies like the 2024 Swedish sibling cohort found no association. Mainstream medical opinion holds that the evidence does not establish a causal link.
Despite these limitations, the Mt. Sinai review and other similar research suggest that caution may be warranted, particularly for heavy or prolonged use of acetaminophen during pregnancy. For this reason, groups like the FDA and the study's authors now recommend a "judicious" approach: use the lowest effective dose for the shortest possible duration under a doctor's guidance.
It is crucial to remember that untreated high fever during pregnancy can also harm a fetus. Therefore, pregnant women should always consult their doctor for personalized advice before making any changes to medication.
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