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USE OF VENLAFAXINE IN PREGNANCY

Date of issue: February 2016
Version: 1.3

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 venlafaxine use in pregnancy is available at www.medicinesinpregnancy.org.

Summary

Venlafaxine is a serotonin and noradrenaline reuptake inhibitor (SNRI) indicated for the treatment of depression. Its mechanism of action is similar to that of selective-serotonin reuptake inhibitors (SSRIs), which have been associated with cardiac malformations in the infant following exposure in pregnancy in some but not all studies.

Data from cohort studies on the use of venlafaxine in human pregnancy do not indicate an increased overall risk of congenital malformation. However, a large case-control study reported associations with a number of specific congenital malformations including hypospadias, gastroschisis, cleft palate, limb, and heart defects. Currently the data are too limited to confirm or exclude an increased risk of malformations after in utero exposure to venlafaxine. 

Associations between maternal exposure to venlafaxine and increased risks of spontaneous abortion and preterm delivery have been reported, however the data are inconsistent and likely confounded by indication and other factors.

Neonatal complications observed in infants exposed to venlafaxine in utero are similar to those reported with SSRIs and include respiratory problems, low apgar score, hypoglycaemia, 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). Monitoring of the neonate post-delivery is advised.

As in utero SSRI exposure is associated with an increase in the occurrence of persistent pulmonary hypertension of the newborn (PPHN), there are theoretical concerns that in utero venlafaxine exposure could also result in PPHN. Although there are no published data which identify an association, data are insufficient to disprove this theory.  An increased risk of PPHN cannot be excluded, although the absolute risk is likely to be low.

Reports of lower than average IQ in children exposed to antidepressants in utero have been found, however the effects of venlafaxine exposure on neurodevelopment have not been widely studied.  Preliminary findings suggest that children exposed to antidepressants in utero, including venlafaxine, and children of untreated depressed women have lower IQs and exhibit more behavioural problems than children of non-exposed children of non-depressed women.

Where maternal treatment with venlafaxine is clinically indicated it should be offered, provided the women is carefully counselled regarding the available human pregnancy safety data or the prescriber considers risk of not treating the maternal condition too great to withhold treatment on the basis of the undetermined fetal risk.

At present there is insufficient evidence to warrant additional fetal monitoring for congenital malformations.  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 considering the need for additional pregnancy monitoring.  Discussion with UKTIS is recommended in all cases.
                     
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.