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Date of issue: March 2023, Version: 3.1

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

The published data regarding atomoxetine use in human pregnancy consist of two case reports and four cohort studies which incorporate a total of 1,621 atomoxetine-exposed pregnancies, including at least 1,465 first trimester exposures. In addition, two population-based cohort studies which utilised an overlapping dataset have investigated ADHD medications as a group.

There is no robust evidence of increased risks of CM overall, cardiac malformations or limb malformations, but the analyses are based on a small number of outcomes which produced imprecise risk estimates.

The controlled data for ADHD medicines as a group describe a possible association with miscarriage, preterm delivery, and decreased five-minute Apgar scores. However, data confounding by the underlying maternal condition may have influenced the observations and a separate analysis of the atomoxetine exposures was not undertaken.

The currently available data for atomoxetine do not raise concern of increased risks of low birth weight and preterm delivery but are too limited to exclude these risks. Data regarding miscarriage and intrauterine death are limited or absent and therefore it is not currently possible to provide an evidence-based assessment of the risks of these outcomes.

It is important that maternal ADHD is adequately controlled during 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).

As with other centrally acting drugs, there is a potential risk of poor neonatal adaptation syndrome (PNAS)/neonatal withdrawal effects and/or persistent pulmonary hypertension of the newborn (PPHN) in the neonate. Infants exposed to atomoxetine in utero should ideally be delivered in a unit with neonatal support and monitored for symptoms of PNAS.

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 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 NHS health care professionals who are logged in.

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.

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