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In utero exposure to methylphenidate, amphetamines and atomoxetine and offspring neurodevelopmental disorders – a population-based cohort study and meta-analysis

In utero exposure to methylphenidate, amphetamines and atomoxetine and offspring neurodevelopmental disorders – a population-based cohort study and meta-analysis
In utero exposure to methylphenidate, amphetamines and atomoxetine and offspring neurodevelopmental disorders – a population-based cohort study and meta-analysis
The use of Attention-Deficit/Hyperactivity Disorder (ADHD) medications during pregnancy is increasing, raising concerns about potential long-term effects on offspring. This study investigates in utero exposure to methylphenidate, amphetamines and atomoxetine and risk of offspring neurodevelopmental disorders (NDDs). The population-based cohort study identified from Swedish registers included 861,650 children born by 572,731 mothers from 2008-2017. We categorized exposure based on redeemed medication during pregnancy and compared exposed children to those whose mothers discontinued medication before conception. Main outcomes were any NDD, including ADHD and autism spectrum disorder (ASD). Cox proportional hazards regression estimated hazard ratios (HRs), adjusting for maternal psychiatric and sociodemographic factors. Sensitivity analyses included stratifications by medication type, timing, and duration of exposure, and sibling comparisons. We also performed a meta-analysis combining data from the present study with those from a previous Danish study. Results showed no increased risk for any NDD (HRadjusted 0.95, 95% CI 0.82-1.11), ADHD (HRadjusted 0.92, 95% CI 0.78-1.08), or ASD (HRadjusted 0.86, 95% CI 0.63-1.18). Sensitivity analyses showed consistent patterns of no increased risks across different exposure durations, medication types and between siblings. Meta-analyses further supported the findings (pooled HR for any NDD 1.00, 95% CI 0.83;1.20). Our study provides evidence that in utero exposure to ADHD medications does not increase the risk of long-term NDDs in offspring. This study replicates safety data for methylphenidate and extends it with new safety data on amphetamines and atomoxetine. These findings are crucial for informing clinical guidelines and helping healthcare providers and expectant mothers make informed decisions.
1359-4184
3885-3894
Bang Madsen, Kathrine
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Larsson, Henrik
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Skoglund, Charlotte
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Liu, Xiaoqing
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Munk-Olsen, Trine
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Bergink, Veerle
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Newcorn, Jeffrey H.
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Cortese, Samuele
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Lichtenstein, Paul
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Kuja-Halkola, Ralf
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Chang, Zheng
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D'onofrio, Brian M.
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Thomsen, Per Hove
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Klungsøyr, Kari
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Brikell, Isabell
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Garcia-Argibay, Miguel
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Bang Madsen, Kathrine
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Larsson, Henrik
4132f7c6-5d52-43a1-be38-d343e67107cf
Skoglund, Charlotte
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Liu, Xiaoqing
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Munk-Olsen, Trine
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Bergink, Veerle
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Newcorn, Jeffrey H.
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Cortese, Samuele
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Lichtenstein, Paul
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Kuja-Halkola, Ralf
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Chang, Zheng
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D'onofrio, Brian M.
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Thomsen, Per Hove
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Klungsøyr, Kari
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Brikell, Isabell
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Garcia-Argibay, Miguel
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Bang Madsen, Kathrine, Larsson, Henrik, Skoglund, Charlotte, Liu, Xiaoqing, Munk-Olsen, Trine, Bergink, Veerle, Newcorn, Jeffrey H., Cortese, Samuele, Lichtenstein, Paul, Kuja-Halkola, Ralf, Chang, Zheng, D'onofrio, Brian M., Thomsen, Per Hove, Klungsøyr, Kari, Brikell, Isabell and Garcia-Argibay, Miguel (2025) In utero exposure to methylphenidate, amphetamines and atomoxetine and offspring neurodevelopmental disorders – a population-based cohort study and meta-analysis. Molecular Psychiatry, 30 (9), 3885-3894, [450]. (doi:10.1038/s41380-025-02968-4).

Record type: Article

Abstract

The use of Attention-Deficit/Hyperactivity Disorder (ADHD) medications during pregnancy is increasing, raising concerns about potential long-term effects on offspring. This study investigates in utero exposure to methylphenidate, amphetamines and atomoxetine and risk of offspring neurodevelopmental disorders (NDDs). The population-based cohort study identified from Swedish registers included 861,650 children born by 572,731 mothers from 2008-2017. We categorized exposure based on redeemed medication during pregnancy and compared exposed children to those whose mothers discontinued medication before conception. Main outcomes were any NDD, including ADHD and autism spectrum disorder (ASD). Cox proportional hazards regression estimated hazard ratios (HRs), adjusting for maternal psychiatric and sociodemographic factors. Sensitivity analyses included stratifications by medication type, timing, and duration of exposure, and sibling comparisons. We also performed a meta-analysis combining data from the present study with those from a previous Danish study. Results showed no increased risk for any NDD (HRadjusted 0.95, 95% CI 0.82-1.11), ADHD (HRadjusted 0.92, 95% CI 0.78-1.08), or ASD (HRadjusted 0.86, 95% CI 0.63-1.18). Sensitivity analyses showed consistent patterns of no increased risks across different exposure durations, medication types and between siblings. Meta-analyses further supported the findings (pooled HR for any NDD 1.00, 95% CI 0.83;1.20). Our study provides evidence that in utero exposure to ADHD medications does not increase the risk of long-term NDDs in offspring. This study replicates safety data for methylphenidate and extends it with new safety data on amphetamines and atomoxetine. These findings are crucial for informing clinical guidelines and helping healthcare providers and expectant mothers make informed decisions.

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Accepted/In Press date: 20 March 2025
e-pub ahead of print date: 27 March 2025
Published date: September 2025

Identifiers

Local EPrints ID: 499761
URI: http://eprints.soton.ac.uk/id/eprint/499761
ISSN: 1359-4184
PURE UUID: 77ae1fdd-70ac-43f1-8a9c-2b842644d199
ORCID for Samuele Cortese: ORCID iD orcid.org/0000-0001-5877-8075
ORCID for Miguel Garcia-Argibay: ORCID iD orcid.org/0000-0002-4811-2330

Catalogue record

Date deposited: 03 Apr 2025 16:39
Last modified: 04 Sep 2025 02:40

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Contributors

Author: Kathrine Bang Madsen
Author: Henrik Larsson
Author: Charlotte Skoglund
Author: Xiaoqing Liu
Author: Trine Munk-Olsen
Author: Veerle Bergink
Author: Jeffrey H. Newcorn
Author: Samuele Cortese ORCID iD
Author: Paul Lichtenstein
Author: Ralf Kuja-Halkola
Author: Zheng Chang
Author: Brian M. D'onofrio
Author: Per Hove Thomsen
Author: Kari Klungsøyr
Author: Isabell Brikell
Author: Miguel Garcia-Argibay ORCID iD

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