You need to be logged in to see the full monograph.

USE OF DULOXETINE IN PREGNANCY

Date of issue: August 2022, Version: 4

Duloxetine is a serotonin noradrenaline re-uptake inhibitor (SNRI) indicated for the treatment of major depressive disorder, diabetic peripheral neuropathic pain, generalised anxiety disorder, and for the treatment of moderate-to-severe urinary stress incontinence. 

The data on duloxetine exposure in pregnancy do not suggest increased risks of congenital malformation overall or cardiac defects specifically, miscarriage, stillbirth, fetal growth impairment, or preterm delivery. Increased risks of poor neonatal adaptation have been observed following third trimester exposure.

Although there are no published data which identify an increased risk of persistent pulmonary hypertension of the newborn (PPHN) with maternal duloxetine use, SNRIs share similar mechanistic properties with SSRIs which are associated with an increased risk of PPHN following use in pregnancy. The possibility of an increased risk of PPHN in the neonate should therefore be considered, particularly as other neonatal problems similar to those reported with SSRIs have also been observed in infants exposed to SNRIs in utero. These include respiratory problems, low Apgar score, hypoglycaemia and convulsions. Infants exposed to antidepressants in utero should ideally be delivered in a unit with neonatal support and the delivery team made aware of the exposure. The neonate should be monitored for adverse effects post-delivery.

It is important to ensure that mental health conditions are treated appropriately. As such, duloxetine may be suitable for use in pregnancy following an individualised assessment of the risks and benefits. Where clinically appropriate, non-pharmaceutical management of depression and/or anxiety could be considered during pregnancy. However, where a patient is stabilised on duloxetine, either prior to conception or during pregnancy, the risk of discontinuing treatment, changing the medication or reducing the dose, should be carefully weighed against the risk of maternal relapse. In cases where treatment with duloxetine is continued in pregnancy, the lowest effective dose should be used.    

Exposure to duloxetine at any stage in pregnancy would not usually be regarded as medical grounds for termination of pregnancy or any additional fetal monitoring. 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.

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.

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 UKTIS.org to ensure you are using the most up-to-date version.