USE OF ACAMPROSATE IN PREGNANCY

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(Date of issue: April 2020, Version: 4)

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.

Summary

Acamprosate is a synthetic amino acid neuromediator analogue that is similar in structure to taurine and gamma-amino-butyric acid (GABA), and which inhibits excitatory neurotransmission. It is licensed for use in conjunction with counselling for maintaining abstinence in alcohol-dependent patients.

Animal reproductive toxicity studies have provided evidence of fetal malformation and increased rates of stillbirth. However, these effects were only observed following administration of doses much greater than those used in human therapy.

Published human data is limited to one population-based retrospective cohort study of 54 acamprosate-exposed pregnancies.  This study does not provide evidence of an increased rate of congenital malformation, preterm delivery, low birth weight or neonatal complications following in utero acamprosate exposure. Rate of miscarriage was not studied.

Unpublished human exposure data consist of a small uncontrolled case series and reports collected prospectively by UKTIS.  These data include cases of miscarriage, congenital malformation, and adverse neurodevelopmental effects.  However, the total number of exposed pregnancies is small (n=32) and data are heavily confounded, in most cases by maternal alcohol use.  It is therefore not possible to reliably comment on the risk posed to the developing fetus following intrauterine acamprosate exposure.

While it is not currently possible to recommend the routine use of acamprosate during pregnancy, alcohol is a confirmed human teratogen, and as such, maternal acamprosate use may be considered beneficial in some cases. Where gestational acamprosate use is considered, the potential risks to the fetus should be weighed against the known risks to both mother and fetus of excessive alcohol exposure, on a case-by-case basis.

Exposure to acamprosate 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. As there are extremely limited data to predict the fetal effects of maternal acamprosate use in pregnancy, particularly following use in the first trimester, additional fetal monitoring may be warranted. Due to the limited amount of data currently available, the reporting of exposures to UKTIS is encouraged.

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.