USE OF VORTIOXETINE IN PREGNANCY

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(Date of issue: May 2022, Version: 1)

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.

A corresponding patient information leaflet on Vortioxetine is available at www.medicinesinpregnancy.org.

Summary

Vortioxetine is a novel multimodal antidepressant of the bisarylsulfonyl amine class. Vortioxetine acts as a serotonin reuptake inhibitor as well as being active at a number of serotonergic receptors. In addition, vortioxetine administration has been reported to increase the efflux of norepinephrine, dopamine and acetylcholine. Vortioxetine is used in the treatment of major depressive episodes.

Data regarding gestational exposure to vortioxetine are limited, and although there is currently no good evidence of an association between gestational exposure to vortioxetine and miscarriage, congenital malformation, intrauterine death, low birth weight or preterm delivery, an increased risk cannot be excluded. There are no data regarding neurodevelopment following gestational vortioxetine exposure.

There are no data regarding neonatal complications following gestational exposure to vortioxetine. Due to the mechanism of action, neonatal complications may theoretically be similar to those observed following exposure to selective serotonin reuptake inhibitors (SSRIs), which include respiratory problems, low Apgar score and convulsions. Use of centrally acting drugs throughout pregnancy or around the time of delivery is associated with an increased risk of poor neonatal adaptation syndrome (PNAS).

Gestational SSRI exposure is associated with a small increased risk (<0.4% vs. 0.1 to 0.2%) of persistent pulmonary hypertension of the newborn (PPHN). Vortioxetine has a similar mechanism of action to the SSRIs and there are theoretical concerns that gestational vortioxetine exposure could also increase the risk of PPHN. Although there are no published data which identify an association between gestational exposure to vortioxetine and PPHN, the available data are insufficient to disprove this theory and an increased risk of PPHN cannot be excluded, although the absolute risk is likely to be low. As PPHN is potentially serious, this should be discussed with women considering vortioxetine use in pregnancy.

The Medicines and Healthcare products Regulatory Agency (MHRA) has advised that there is a small overall increased risk of postpartum haemorrhage (PPH) attributable to SSRI/selective noradrenaline reuptake inhibitor (SNRI) use in the month prior to delivery, but this risk may be higher in women with other risk factors for abnormal bleeding. Although no studies have investigated an association between vortioxetine and PPH, as vortioxetine has a similar mechanism of action to the SSRIs, there are theoretical concerns that gestational vortioxetine exposure could increase the risk of PPH. Careful assessment of the risk of PPH versus the risk of maternal relapse should the medication be discontinued is advised when considering continued use in late pregnancy. Prescribers are also encouraged to ensure maternal compliance with heparin self-administration in all pregnant women with risk factors for venous thromboembolism.

It is important to ensure that mental health conditions are treated appropriately. As such, vortioxetine 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 vortioxetine, 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 vortioxetine is continued in pregnancy, the lowest effective dose should be used.

 
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.