USE OF FLUOXETINE IN PREGNANCY

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(Date of issue: January 2017, Version: 2.2)

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

Summary

Fluoxetine is a selective serotonin reuptake inhibitor (SSRI) used in the treatment of depression, obsessive-compulsive disorder and bulimia nervosa.

The majority of studies have demonstrated no statistically significant increase in overall risk of any malformation, with only one cohort study and two meta-analyses which combined the same primary data suggesting a slight increase in occurrence. Data concerning the risk of cardiac malformation following fluoxetine use in early pregnancy are conflicting, and whilst most studies have shown no association, three cohort studies and a meta-analysis have provided evidence of a slight increase in absolute risk above the background rate. It should be noted however that the majority of the available studies do not take maternal alcohol use into account. Since the published data are contradictory, the teratogenic potential of fluoxetine currently remains unproven.

There is no good evidence of an association between fluoxetine use in pregnancy and spontaneous abortion, intrauterine death, preterm delivery, low birth weight and neurodevelopmental delay. However, the available data are too limited to state that there is no increase in risk.

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, fluoxetine 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 fluoxetine, 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 fluoxetine is continued in pregnancy, the lowest effective dose should be used. 

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