USE OF PAROXETINE IN PREGNANCY

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(Date of issue: January 2017, Version: 2.3)

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

Summary

Paroxetine is a selective serotonin reuptake inhibitor (SSRI) used in the treatment of depression, obsessive-compulsive disorder, post-traumatic stress disorder, anxiety disorders (generalised or social) and panic disorder with or without agoraphobia.

Data on the risk of congenital malformations following paroxetine use in early pregnancy are conflicting; the majority of individual studies have demonstrated no statistically significant increase in the overall risk of any malformation or of cardiac malformations specifically. However, some, but not all, meta-analyses have identified significant increased rates of both cardiac malformations and malformations in general, although the latter finding is considered to have been significantly influenced by the increased rate of cardiac malformation.

As a result of a potential signal of paroxetine teratogenesis in 2005 it is currently the most studied of the SSRIs. However, increased rates of cardiac malformation in offspring exposed to other SSRIs in the first trimester have also been demonstrated. Furthermore, antidepressants as a group of medications have also been associated with cardiac anomalies. It is therefore unclear whether the available findings concerning maternal paroxetine use in pregnancy represent a risk with the individual drug, a class effect of SSRIs, or are produced due to confounding from other factors related to the maternal illness. The teratogenic potential of paroxetine therefore remains unclear. Those studies that do show an increase in risk of cardiac malformation suggest that the absolute risk (0.86-2.15%) is only slightly raised above the background rate (0.8%).

The evidence regarding the risk of spontaneous abortion and preterm delivery with paroxetine exposure is also conflicting. No association with intrauterine death or low birth weight has been found.

In utero exposure to any SSRI in the weeks prior to delivery confers a risk of transient neonatal withdrawal syndrome and infants should be monitored for associated central nervous system, motor, respiratory, and gastrointestinal symptoms. An increased risk of persistent pulmonary hypertension (PPHN) of the newborn has also been reported following exposure to SSRIs as a class beyond 20 weeks of gestation and, although this remains an uncommon event (0.2-1.2% vs. 0.1-0.2% in the background population), it represents a potentially serious neonatal complication.

It is important to ensure that maternal mental health is treated appropriately. As such, paroxetine may be suitable for use in pregnancy, but the risks and benefits of use must be considered on a case-by-case basis. Where possible, non-pharmaceutical management of depression and/or anxiety is preferable in pregnancy. Where a patient is stabilised on paroxetine, 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 maternal relapse during pregnancy may pose to both mother and child. In cases where treatment with paroxetine is continued in pregnancy, the lowest effective dose should be used. 

At present there is insufficient evidence to warrant additional fetal monitoring. Exposure to paroxetine 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.

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.