USE OF DOSULEPIN IN PREGNANCY

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(Date of issue: April 2019, Version: 2.1)

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

Summary

Tricyclic antidepressants (TCAs) block the re-uptake of both serotonin and noradrenaline and are used in the management of depression, anxiety disorders and neuropathic pain. Currently available TCAs include amitriptyline, clomipramine, dosulepin, doxepin, imipramine, lofepramine, nortriptyline and trimipramine. 

The available data provides no strong evidence of an association between maternal use of TCAs as a class during pregnancy and an increased risk of congenital malformation overall, or of any specific malformations. There is limited or no information on use of specific TCAs, therefore an increased risk of malformations cannot be ruled out. A possible association between in utero clomipramine exposure and cardiac malformations has been suggested but remains to be confirmed. Other findings are conflicting; however possible associations with spontaneous abortion, preterm delivery, preeclampsia, and autism spectrum disorder have been identified.

An increased incidence of neonatal complications has been reported in the offspring of women with psychiatric illnesses; however the relative contributions of the underlying maternal condition and specific drug treatments have not been clearly defined. Use of TCAs throughout pregnancy or near delivery may be associated with withdrawal symptoms in the neonate and/or poor neonatal adaptation syndrome (PNAS). These symptoms are likely to be more severe in infants exposed in utero to more than one CNS acting drug.

It is important to ensure that maternal mental health disorders are treated appropriately during pregnancy. Where a patient is stabilised on a TCA, either prior to conception or during pregnancy, the risk of discontinuing or changing medication, or reducing the dose, should be carefully weighed against the risk of relapse of the maternal condition.

The currently available data do not support the need for any additional fetal monitoring following in utero exposure to TCAs; however data on individual TCAs is limited and the need for additional monitoring should therefore be determined on a case-by-case basis. Other risk factors may also 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.