PainRelief.com: What are the main findings?
Response: In our study or more than 1.2 million births in Sweden, we used several statistical methods and advanced designs to try to account for potential sources of bias. Our results do not support any substantial increased risk for ASD or ADHD at the levels of exposure observed in our cohort.
PainRelief.com: What should readers take away from your report?
Response: There are many background factors that may lead to being prescribed opioid pain medication that may also increase risk for neurodevelopmental disorders, such as genetic and environmental factors. When evaluating the risks of medication exposure during pregnancy, it is essential to account for these factors which may confound associations.
For example, in our initial analysis comparing exposed children to unexposed, unrelated children, we identified similar increased risks for ASD and ADHD as past studies, particularly with greater dose and duration of exposure. However, when we compared siblings who were and were not exposed in utero, thereby adjusting for environmental and genetic factors that are shared by siblings, those risks were largely diminished. Thus, it is likely that the increased risks observed initially are largely due to other factors (e.g., genetic and environmental factors), rather than a causal effect of the medication.
PainRelief.com: What recommendations do you have for future research as a result of this study?
Response: As with any scientific study, there are always limitations. In our study we could not examine the effects of extremely high doses due to the prescribing patterns that were present in our cohort. It will be important for future studies to examine higher amounts of exposure and see whether these results are replicated in different samples outside of the medical and social context of Sweden. Additionally, there are other risks to be considered, such as potential increased risk for preterm birth or other adverse birth outcomes, that require further study.
PainRelief.com: Is there anything else you would like to add?
Response: When weighing risks and benefits of the use of opioid pain medications during pregnancy, it is essential to not only consider the potential for medication impacts on child development, but to also consider the potential consequences of inadequately managed pain for the pregnant person. We hope that this study can be another source of data to consider and provide some reassurance that with judicious opioid prescribing, the results do not support substantial increased risks for neurodevelopmental disorders.
Disclosures: This research was supported by grants from the National Institute on Drug Abuse of the National Institutes of Health (T32DA024628-15, R01DA048042). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Citation: Cleary, E.N., Sujan, A.C., Rickert, M.E., Fischer, F., Lagerberg, T., Chang, Z., Lichtenstein, P., Quinn, P.D., Öberg, A.S., & D’Onofrio, B.M. (2025). Prescribed opioid analgesic use in pregnancy and risk of neurodevelopmental disorders in children: A retrospective study in Sweden. PLOS Medicine. https://doi.org/10.1371/journal.pmed.1004721
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Last Updated on September 30, 2025 by PainRelief.com