USE OF ATOMOXETINE IN PREGNANCY

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(Date of issue: December 2017, Version: 2)

This is a UKTIS monograph for use by health care professionals. For case-specific advice please contact UKTIS on 0344 892 0909. To report an exposure please download and complete a pregnancy reporting form. Please encourage all women to complete an online reporting form.

Summary

Atomoxetine is a selective noradrenaline reuptake inhibitor (NRI) used in the treatment of attention deficit hyperactivity disorder (ADHD). 

The published data concerning atomoxetine use in human pregnancy consist of two case reports of gestational atomoxetine use at an unspecified stage of pregnancy, and two population-based cohort studies which utilised an overlapping dataset and investigated ADHD medications as a group. The controlled data describe a possible association with spontaneous abortion and decreased five minute Apgar scores. However, data confounding by the underlying maternal condition may have influenced the spontaneous abortion observations and a separate analysis of the atomoxetine exposures was not undertaken.

Due to the limitations of the available data, it is not currently possible to provide an evidence-based risk assessment regarding the use of atomoxetine in pregnancy. The risks of destabilisation and maternal relapse must be taken into account when considering dose reduction or switching a patient from atomoxetine to another medication(s).

Based on pharmacodynamic similarities between NRIs and SSRIs, a theoretical risk of poor neonatal adaptation syndrome (PNAS)/neonatal withdrawal effects and/or PPHN in the neonate cannot be excluded. Infants exposed to atomoxetine in utero should ideally be delivered in a unit with neonatal support and monitored for symptoms of PNAS, which will vary depending on a number of factors including the rate at which the mother and baby metabolise a drug, dose and trimester of exposure. 

Exposure to atomoxetine at any stage in pregnancy would not usually be regarded as medical grounds for termination of pregnancy. However, other risk factors may be present in individual cases which may independently increase the risk of adverse pregnancy outcome. Clinicians are reminded of the importance of consideration of such factors when performing case-specific risk assessments. Given the lack of sufficient human pregnancy exposure data, the need for additional antenatal anomaly scans and/or fetal monitoring should be considered on a case-by-case basis following maternal atomoxetine use in pregnancy.

This document is regularly reviewed and updated. Only use full UKTIS monographs downloaded directly from TOXBASE.org to be sure you are using the most up-to-date version. The summaries of these monographs are openly available on UKTIS.org.

This is a summary of the full UKTIS monograph for health care professionals and should not be used in isolation. The full UKTIS monograph and access to any hyperlinked related documents is available to health care professionals at www.toxbase.org.

If you have a patient with exposure to a drug or chemical and require assistance in making a patient-specific risk assessment, please telephone UKTIS on 0344 892 0909 to discuss the case with a teratology specialist.

If you would like to report a pregnancy to UKTIS please click here to download our pregnancy reporting form. Please encourage all women to complete an online reporting form.

Disclaimer: Every effort has been made to ensure that this monograph was accurate and up-to-date at the time of writing, however it cannot cover every eventuality and the information providers cannot be held responsible for any adverse outcomes of the measures recommended. The final decision regarding which treatment is used for an individual patient remains the clinical responsibility of the prescriber. This material may be freely reproduced for education and not for profit purposes within the UK National Health Service, however no linking to this website or reproduction by or for commercial organisations is permitted without the express written permission of this service. This document is regularly reviewed and updated. Only use UKTIS monographs downloaded directly from TOXBASE.org or UKTIS.org to ensure you are using the most up-to-date version.